Endo Pharmaceuticals / Par Pharmaceutical

55 job(s) at Endo Pharmaceuticals / Par Pharmaceutical

Endo Pharmaceuticals / Par Pharmaceutical Field, Ohio
Description Job Summary - a concise overview of the job Endo Aesthetics is an exciting new affiliate of Endo International focused on providing physicians and their patients with expanded choices in medical aesthetic treatments and procedures. We are seeking a passionate, driven Aesthetic Business Manager (ABM) to launch a new and innovative cellulite treatment to the market. The ABM will be responsible for prospecting customers in the medical aesthetic market, providing product information/clinical data, facilitating training, in-practice marketing and sharing appropriate information regarding Endo Aesthetics. The ABM will develop new accounts in the defined geographic territory while meeting and exceeding established sales quotas. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Endo Aesthetics Business Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of Time §  Accountable for meeting or exceeding assigned sales objectives on a monthly, quarterly and annual basis.§  Develops quarterly, monthly and weekly plans designed to maximize customer relationships and improve face-to-face selling time in assigned territory.§  Communicates initial strategy for all new pipeline opportunities and works with Regional Sales Manager (RSM) on how to advance all such opportunities through the sales cycle.§  Communicates and monitors all opportunities in a timely fashion and with a sense of urgency.§  Delivers tangible near term actions with a vision to longer-term sustainable revenues across company offerings.§  Through active listening and questions, understands and has the ability to influence the customer's decision-making process and leads the customer to positive decisions.§  Demonstrates strong customer service focus and ability to effectively communicate value propositions.§  Develops and maintains a strong relationship with Regional Sales Manager that enables collaborative efforts to be utilized.§  Develops strong relationships with key decision makers at multiple levels.§  Is proficient in knowledge of Endo products and of competitive products and positioning.§  Responsible for demonstrating knowledge of target customers, competitive accounts, new growth opportunities and time and territory management; submitting reports to RSM consistently on a weekly basis.§  Implements key marketing strategies, business objectives, and treatment/practice growth plans.§  Develops a working territory business plan that includes account segmentation, forecasting, marketing initiatives, and sales execution strategies (i.e. staff training pull through plans, in-office events, etc.).§  Develops and coordinates physician training programs, practice enhancement in-services, and patient events.§  Demonstrates and provide technical product and procedure expertise.§  Completes all assigned paperwork in a timely and accurate manner (i.e. expense reports, business plans, etc.).§  Ensures individual and Company compliance with all federal, state, and local laws, and all company policies and procedures Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree or equivalent experience within an aesthetic medical practice·       5+ years successful medical/dental/device sales or a combination of Business to Business and medical/dental/device and sales·       Demonstration of sustained, high performance (President’s Club, Circle of Excellence or equivalent top sales award) ·       New product launch and/or experience capitalizing on new market opportunities·       Medical aesthetic industry experience (preferred)KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Experience and knowledge of general marketing principles and concepts within an aesthetic or other relevant medical practice§  Experience and knowledge of inner workings of a physician’s practice§  Strong knowledge of the aesthetic market in the assigned territory§  Consultative selling skills and/or B2B selling experience in the aesthetic medical space§  Strong customer service focus and ability to effectively communicate value propositions§  Successful experience with KOL identification and developmentSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  High level of business acumen§  Proven consultative selling skills§  Strong analytical skills§  High customer service orientation with a sense of urgency to respond to the needs of the customer§  Strong conflict and problem resolution skills§  Ability to develop key strategies at the account level and effectively execute§  Strong interpersonal skills§  Strong negotiating skills§  Financial/budgetary experience§  Highly organized and able to prioritize effectively§  Strong presentation, verbal and written communication skills§  Proficiency with Excel, Word, PowerPoint and other software skills§  Ability to travel as required by specific territories§  High aptitude for learning, coaching, and situational awareness§  Ability to work independently and collaborativelyPhysical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Overnight travel may be required Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Chestnut Ridge, New York
Description Job Summary - a concise overview of the jobUnder the general direction of the Customer Due Diligence & State Licensing Manager, the Customer Due Diligence & State Licensing Specialist will assist with all day-to-day operations.  The Associate will be responsible for all aspects of state licensing and registering of the company facilities with the appropriate state agencies including, but not limited to, initial licensure, renewals, decommissioning/site closures, change of corporate ownership, corporate name changes, filing of new officers, directors or designated site reps, scheduling new facility or renewal inspections, surety bond maintenance, arranging fingerprinting and background checks, submitting check requests, preparing documents for physical or on-line submissions. Collaborate with other teams on licensing nuances, specific state filings challenges and/or special projects. Monitor state regulatory changes through third party system to ensure company is in compliance at all times. Communicate directly with state agencies on matters related to licensure. Foster and build strong business relationships with related state agencies and industry organizations. Maintain state licensing spreadsheet and database. Ensure all files, electronic and hard copy, are up-to-date in accordance with corporate record retention policies.  With respect to Customer Due Diligence, the Associate will assist with reviewing flagged orders in the order analysis system, release justified orders, investigate and escalate questionable orders, reach out to customers as needed, work with 3PL SOMs team to resolve issues, maintain point of contact spreadsheet, maintain logbook and hard copy records. Be able to provide backup and handle operations when Customer Due Diligence and State Licensing Manager is out of the office. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.§  No budget authority. §  No decision-making authority. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeRegulatory§   Prepares and submits state licensing documents (i.e. renewals, initial applications, letters of notification, etc.)§   Monitors third-party vendor regulatory database for legislative changes and advises team-ensuring company is in compliance at all times.30%Data Analysis §   Reviews orders of interest in OAS system. Releases justified orders.§   Escalates questionable orders for additional investigation.25%Documentation§   Maintains Licensing, Point of Contact and Logbook spreadsheets§   Maintains electronic and hard copy files for auditing and corporate record retention purposes. 25%Liaison§   Serves as the primary contact with the state licensing agencies and a secondary contact in relation to customer due diligence.10%
Endo Pharmaceuticals / Par Pharmaceutical Chestnut Ridge, New York
Description Job Summary - a concise overview of the jobThe Controlled Substances & Reference Standard Coordinator is responsible for managing the control substances program and the reference standard program of the analytical laboratory. The position requires a higher level of understanding of the testing requirements and methodologies typically used in any pharmaceutical laboratory. Also, the incumbent must have a good understanding of DEA and FDA regulations in dealing with controlled substances used as medicine. In order to manage both programs, the Controlled Substances & Reference Standard Coordinator will be responsible for dispensing, and continually writing and reviewing Lab notebooks, reports and protocols. He/she is responsible for working to ensure compliance in each laboratory.All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Scope covers the Generics business, typically supporting one site, as well as Endo R&D and Commercial. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeCompliance§  Uses laboratory software for control substance management in LIMS (laboratory Information management system).§  Receives and dispenses controlled substances to analysts for testing; dispenses reference standards.§  Reconciles controlled substances in LIMS for reporting and disposing; Maintains inventory of controlled substances.§  Responsible for the disposal and destruction of the controlled substances.§  Procures USP and other primary standards and manages the inventory.§  Responsible for the removal of expired standards from the program.75%Collaboration§  Works with the DEA /QA to complete the biannual inventory.§  Works with R&D DEA coordinators to complete bi-annual inventory.§  Interacts with internal DEA group and regulatory groups as needed.20%Training§  Provides effective training for application of new processes, revisions of DEA requirements, and new guidelines.5%Technical§  Maintains knowledge of regulations, cGMPs, and current industry standards and guidance.§  Actively monitors compendia communications for reference standard updates, and determines if the updates have any effect on current reference standard programs.ContinuousTotal100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree in Chemistry or related scientific discipline with a minimum of 3-5 years’ experience in Quality Control R&D in a pharmaceutical company.§  Experience in technical writing, including requirements gathering, is required.KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Good understanding of DEA and FDA regulations in dealing with controlled substances used as medicine.§  Working knowledge of regulations, cGMPs, and current industry standards and guidance.§  Working knowledge of HPLC/GC to work in the lab if required.§  Working knowledge and hands on experience with LIMS software.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Ability to audit, communicate issues and develop resolutions.§  Ability to apply project management skills to ensure fulfillment of long-term requirements is required.§  Ability to read and interpret governing body regulations.§  Must be detail oriented and have the ability to prioritize work.§  Ability to lead, manage and participate on teams.§  Ability to work well independently and in a team environment.§  Demonstrated proficiency at a baseline level with MS Office Suite including MSWord, MS Excel, MS PowerPoint, and MS Access is required. §  Ability to prioritize work.§  Training capabilities.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to sit/stand in an office and lab environment. Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Rochester, Michigan
Description Job Summary - a concise overview of the jobThe Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.  Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment.  Detects, conducts, and reports on OOS/OOT/NOE and other investigations.  Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.  Participates in troubleshooting analyses and instrumentation.  Trains less senior staff.  All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Typically supports one Par business, at a single site Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeAnalysis & Testing§  Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. §  Uses laboratory software for analyses§  Reviews and approves laboratory test data and documentation for completeness and compliance§  Is alert to and detects abnormalities during performances of tests and reviews. Elevates abnormalities to Supervisor§  Performs lab methods transfer and participate in method validation/verification studies65%Lab Equipment§  Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping§  Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals§  Troubleshoots instrument/chromatography problems and identifies improvements/CAPAs20%Investigations§  Detects, conducts and reports on OOS/OOT/NOE and other investigations§  Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action§  Writes, edits and reviews SOPs and laboratory investigations10%Training§  Maintains assigned training records current and in-compliance§  Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures5%Compliance§  Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting §  Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs§  Follows internal processes related to controlled substancescontinuousSafety§  Follows EH&S procedures to ensure a safe work environment§  Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDScontinuousTotal100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR§  Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experienceKnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports§  Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.§  Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS§  Has demonstrated competence in conducting chemical analyses§  Strong knowledge of wet chemistry techniques§  Competency in Microsoft Office SuiteSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific   e.g. coaching, negotiation, calibration, technical writing etc.§  Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information§  Ability to display and analyze data in a logical manner§  Strong verbal and written communication skills as well as good computer skills§  Strong attention to details and accurate record keeping§  Establish and maintain cooperative working relationships with others§  Solid organizational skills§  Ability to coach less senior staff and develop laboratory skills and ability§  Ability to take initiative, set priorities and follow through on assignmentsPhysical RequirementsPhysical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.  Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals§  Must occasionally lift and/or move up to 15-25 lbs.§  Ability to wear personal protective equipment, including respirators, gloves, etc. §  Specific visions abilities are required by this job include close vision and color vision§  Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Irvine, California
Description Reliability Technician III, Engineering Services, Irvine, CA About Par Pharmaceutical:Par Pharmaceutical, headquartered in Chestnut Ridge, NY, develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patient quality of life. Par, among the top leaders in the U.S. generics industry, possesses a portfolio that includes sterile injectables, alternative dosage forms and many other differentiated products. Par is advancing a robust research and development (R&D) pipeline of potential products.  Par is an operating company of Endo International plc (NASDAQ: ENDP), a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients through excellence in development, manufacturing and commercialization. Learn more at www.endo.com or www.parpharm.com. POSITION SUMMARY:Performs facility reliability maintenance activities in accordance with approved procedures, requiring limited supervision.  Proficient at analyzing and troubleshooting the root cause of facility equipment problems.  May also be required to be proficient at analyzing and troubleshooting the root cause of manufacturing equipment problems.  Implements effective preventive and/or corrective maintenance repairs to provide increased reliability.  Assists in developing standard operating procedures (SOPs) and proactive maintenance (PM), and may assist in planning non-destruct test methods and participates in the P-F curve analysis and FMEA.  Refers deviations from SOPs to the supervisor.  Identifies maintenance improvements that increase efficiency, throughput, and quality.  May train others in setting up equipment.  Identifies and solves complex problems.  Understands the practical application to problems and situations ordinarily encountered and makes decisions that require choosing from several options.ROLE AND RESPONSIBILITIES:Independently performs preventive and predictive maintenance tasks on all facility equipment according to the frequency written in SOPs.Performs condition-based monitoring while PM's are being performed, and notes problems or changes in the comment section of the PM form.Adheres to Reliability Centered Maintenance (RCM) strategies utilizing a pro-active approach to minimize equipment downtime.Independently troubleshoots problems or breakdowns on control valves, motors, pumps, actuator, HVAC controls, boilers, chillers, domestic water, compressed air systems, deionized water systems, and other facilities equipment in the plant. May also independently troubleshoot problems and breakdowns on agitators, tablet presses, encapsulation machines, blenders, ovens, vectors, fitzmills, and other production equipment in the Manufacturing department.May work on packaging or manufacturing equipment as required.Supports engineering and capital projects with input on equipment acquisition or repair.Completes work in a timely fashion and motivates others to do the same.Contributes to team and project success by sharing previously acquired knowledge.Collaborates within own work unit and with those from other departments outside of work unit and/or with external vendors/suppliers.Motivates others to achieve high levels of competence and provides on the job training and guidance as requested.Assists in developing SOPs and PM’s, and may assist in planning non-destruct test methods and participates in the P-F curve analysis and FMEA.Conforms to all training requirements, including Company required and utilities equipment training.Provides on the job training and guidance to other Facilities Reliability Technicians.Attends all Maintenance and other meetings when mandatory.Follows all applicable SOPs, including, but not limited to, lock-out, tag-out and PPE requirements.Performs other duties as assigned.REQUIRED QUALIFICATIONS:A high school diploma or equivalent is required, with 7+ years’ related experience and certification in assigned area(s), as required.ACCP-Level II Certification or equivalent experience.Has a wide range of technical skills and operational knowledge in procedures, techniques, tools, materials, and/or needed equipment.Understands the practical applications to problems and situations ordinarily encountered.Fully knowledgeable of cGMP regulations and processes.Understanding of Non-destruct Test Methods, P-F curves and FMEA desired.Knowledge of equipment capabilities and the ability to train others.Knowledge of processes described in SOPs, where to find and how to use SOPs, and have the ability to train others in relevant SOPs and documentation.Qualified with appropriate certifications, as required, and demonstrates competence in equipment maintenance, repair and set-up.Troubleshoots all relevant equipment independently.Assesses and performs PM tasks and trains others in this area.Reads and follows schematics, engineered drawings, technical drawings, and/or blueprints.Interfaces with external vendors and service providers.Ability to use the BMS (Bldg. Management System) for HVAC.Basic math, writing skills, problem solving.Basic computer skills.Ability to use hand tools.Control Precision - ability to quickly and repeatedly adjust the controls of a machine to exact positions.Proficient in troubleshooting & repair in 4 or more of the following areas:ElectricalHydraulicsPneumaticsMechanicalPLC'sSpecialized in at least 4 of the following 5 areas:Utility – purified water systems, compressed air, boiler, chilled water, electrical distribution, product dust collection systems.Building Maintenance – sewers, electronic card readers (when applicable), lighting.Fire suppression systems.HVAC competence and certification, as required.General building & grounds maintenance. PHYSICAL REQUIREMENTS:Must be able to stand for long periods of time (12 hour shifts).Lift at least 50 pounds.Climb ladders.Wear a respirator and pass associated respirator tests and/or requirements.Able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.Reaction Time - ability to quickly respond with manual dexterity to a signal (sound, light, picture) when it appears.Dexterity - ability to make precisely coordinated movements of the fingers of one or both hands to grasp, manipulate, or assemble very small objects.Vision - ability to see details at close range (within a few feet of the observer).Hearing - ability to detect or tell the differences between sounds that vary in pitch and loudness. Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Endo Pharmaceuticals / Par Pharmaceutical Rochester, Michigan
Description Manager, Maintenance Engineering, Engineering Services, Michigan-Rochester About Endo International plcEndo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA, employing approximately 3,000 people worldwide.  For 2018 Endo, reported revenue of $2.947B and adjusted diluted EPS of $2.89.  Learn more at www.endo.com. POSITION SUMMARY: The Manager, Maintenance Engineering oversees the staff and maintenance of equipment and facilities.  This includes systems utilized by the maintenance department to monitor and control environmental condition and processes (i.e. BAS, Calibration, PLC, and control systems). This position will work with the operations managers and supervisors to prioritize work activities and dispatch the correct trade in a timely manner. ROLE AND RESPONSIBILITIES: Equipment and Facilities MaintenanceAssures that equipment is maintained in accordance with all cGMP, OSHA, governmental, and corporate standards.Directs engineering investigations and prepares written reports when product-related equipment and system abnormalities occur.Oversees the operation of the WFI, clean steam, compressed air, and nitrogen systems.Monitors and prioritizes maintenance needs and assigns work as priorities dictate.Investigates and analyzes accidents involving equipment and systems; takes appropriate corrective actions to eliminate safety hazards; and completes any required documentation in a timely manner.Actively participates in regulatory and contract customer audits involving equipment.Collaborates with Tech Ops and Manufacturing to support project work and new equipment FATs to ensure a smooth transition of equipment and process to operation.Coordinates activities with the EHS team to assure that new and existing equipment applications are designed to minimize personnel safety hazards.Misc. Support and CommunicationLeads and/or actively participates in the project management of new product and process implementations.Collaborates with Manufacturing, Pharmaceutical Technology, and Quality Operations to control and reduce production variances. Supports project work of PMO office as needed.Provides regular reports to communicate departmental activities, project status, and events that impact manufacturing operations.People ManagementConducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution maintenance staff.Ensures that all staff are trained on the most updated version of the operating procedures.Hires, trains, and manages performance of staff. Sets goals and objectives for individuals and teams.Identifies and evaluates employee training requirements.Delegates work duties to individual staff members.BudgetAccurately forecasts manufacturing maintenance budget needs. REQUIRED QUALIFICATIONS: Education & ExperienceBachelor of Science degree in Chemical, Mechanical, or Electrical Engineering or related studies required with 10+ years’ progressive technical experience ORMS with 8+ years’ experience as noted above.Previous facility/production maintenance experience in a cGMP or regulatory environment is preferred.Previous supervisory experience is preferred.Pharmaceutical industry experience is preferred. Hands-on experience working with industrial automation such as Programmable Logic Controller (PLC), Variable Frequency Drive (VFD), etc. KnowledgeStrong knowledge of Manufacturing processes and equipment.Knowledge of pharmaceutical QMS requirements for change control, investigations, and good documentation practices.Knowledge of  Blue Mountain Regulatory Asset Management or equivalent ProgramKnowledge of Building Management Systems, including State and County codes. Skills & AbilitiesExpertise with Microsoft software (e.g. Word, Excel, Project, PowerPoint, Outlook, Visio). Must have the ability to work effectively with a computerized maintenance management system and instruct others on its operation.Able to understand and follow oral and written instructions.Able to communicate clearly and concisely, both oral and writing.Ability to define problems, collect data, establish facts, and draw valid conclusions and deal with several abstract and concrete variables.Ability to plan and manage multiple projects simultaneously.  Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes oneself available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. PHYSICAL REQUIREMENTS: Will sit or stand for long periods of time throughout the day.Required to lift up to 50 lbs.Will walk and climb stairs.Will reach over shoulder heights and below waist.Required to use hands to lift, handle, carry or feel.May be required to kneel, bend, talk and hear.The noise level in the work environment is usually moderateSpecific vision abilities required by this job include color visionOccasionally exposed to moving mechanical parts; outside weather conditions and risk of electrical shock. ADDITIONAL INFORMATION: Afternoon shift premium is 10% (non-union positions only)Midnight shift premium is 15% (non-union positions only)  Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.  Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled *LI-ENDP 
Endo Pharmaceuticals / Par Pharmaceutical Malvern, Pennsylvania
Description Job Summary - a concise overview of the jobThe Regulatory Affairs Labeling Director is a key member of the Regulatory Affairs Labeling team and reports directly to the Regulatory Affairs Vice President. The Labeling Director will be responsible for certain projects in the development/revision of labeling for both NDA and ANDAs and play an integral role in leading the Regulatory Affairs Labeling Team. The Labeling Director will be expected to work in an environment that requires strict adherence to procedures necessary to ensure error free labeling and FDA submissions. §  Provide labeling support for achieving key milestones for each developmental lead project while maintaining labeling support for all marketed products (NDA and ANDA).§  Responsibility for implementation of reference listed drugs (RLD) labeling updates for ANDAs.§  Author labeling section for all NDA and contract manufactured ANDA’s Annual Reports.§  Coordinate all labeling development, reviews and approvals through the RA Labeling Group§  Development/revision and adherence to Labeling SOPs and Business Practices§  Responsibility for developing and managing updates to carton and container labeling/artwork§  Responsibility for managing key labeling-related FDA activities such as NDC management, bar code requirements, SPL requirements, serializations issues, and any other labeling regulated activities as needed§  Responsibility for providing oversight and guidance for QC/audit checks of labeling throughout the company All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Branded & Generics; partner with India & NY to aid in more consistent labeling processes Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeLeadership§  Represent the RA Labeling Group at meetings for assigned projects§  Coordinate labeling review and approval process for both branded and generic drugs§  Chair the Labeling Review Committee for assigned projects30%Business§  Participate on New Product Development and Marketed Product teams, providing regulatory support to assure that labeling regulatory  requirements are incorporated as part of the product development process and life cycle management§  Develops regulatory strategies with an accurate assessment of regulatory impact and risk§  Development/revision and adherence to Labeling SOPs and Business Practices30%Organization Support§  Responsible for managing the development of artwork for branded and generic product labeling§  Author labeling section for all NDA and ANDA Annual Reports§  Prepare and manage labeling submissions to FDA§  Prepare Labeling for quarterly Periodic Safety Reports (PSR)§  Responsible for managing the creation of branded and generic pharmaceutical Structured Product Labeling (SPL) documents§  Responsible for  the creation of interactive Package Inserts (PIs) for Endo.com website§  Responsible for  the creation of carton and container labeling (management of artwork vendors)§  Manage the complete Drug Listings for branded and generic pharmaceuticals§  Responsible for managing key labeling-related FDA activities such as NDC management, bar code requirements, SPL requirements, serializations issues, and any other labeling regulated activities as needed§  Responsible for providing oversight and guidance for QC/audit checks of labeling throughout the company40%Customer Focus§  Work with contract manufacturers and labeling vendors§  Working with cross-functional team members both within Endo and with the partner companiescontinuousTotal100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Minimum Bachelor’s Degree or equivalent experience.§  Minimum 10 years pharmaceutical industry experience with 3 years Regulatory Affairs/Labeling experience.§  Broad based pharmaceutical industry knowledge (Regulatory, Manufacturing, Quality Assurance, Supply Chain, Marketing)§   Experience working with Quark, Photo Shop, InDesign and Illustrator software is a plusKnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Strong knowledge of regulations/guidelines governing labeling of pharmaceutical products is required, for both branded and generic drugs§  Working knowledge of FDA electronic submission documents required.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Strong, professional interpersonal skills including ability to communicate effectively with people individually and groups; experience establishing and maintaining effective relationships with business leaders and external partners; ability to manage stressful situations§  Experience consulting with senior scientific, research and commercial professionals and ability to interact with diplomacy and tact and to influence decision making related to regulatory compliance.§  Experience participating on and leading teams with shared responsibility for outcomes and decision-making; operate across matrix comfortably; establish expectations and team roles; develop and implement communication and follow-up approaches; resolve conflicts§  Experience working independently with minimal supervision§  Knowledge of regulations relating to prescription drug labeling are essential, both for branded and generic products§  Excellent proof reading skills§  Proficiency in art work development using InDesign, and Illustrator software is a plus§  Problem Solving§  Priority Setting§  Drive for Results§  Motivating Others§  Integrity and Trust§  Customer FocusPhysical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to work in an office environment  Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Remote, Texas
Description Job Summary - a concise overview of the job Endo Aesthetics is an exciting new affiliate of Endo International focused on providing physicians and their patients with expanded choices in medical aesthetic treatments and procedures. We are seeking a passionate, driven Aesthetic Business Manager (ABM) to launch a new and innovative cellulite treatment to the market. The ABM will be responsible for prospecting customers in the medical aesthetic market, providing product information/clinical data, facilitating training, in-practice marketing and sharing appropriate information regarding Endo Aesthetics. The ABM will develop new accounts in the defined geographic territory while meeting and exceeding established sales quotas. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Endo Aesthetics Business Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of Time §  Accountable for meeting or exceeding assigned sales objectives on a monthly, quarterly and annual basis.§  Develops quarterly, monthly and weekly plans designed to maximize customer relationships and improve face-to-face selling time in assigned territory.§  Communicates initial strategy for all new pipeline opportunities and works with Regional Sales Manager (RSM) on how to advance all such opportunities through the sales cycle.§  Communicates and monitors all opportunities in a timely fashion and with a sense of urgency.§  Delivers tangible near term actions with a vision to longer-term sustainable revenues across company offerings.§  Through active listening and questions, understands and has the ability to influence the customer's decision-making process and leads the customer to positive decisions.§  Demonstrates strong customer service focus and ability to effectively communicate value propositions.§  Develops and maintains a strong relationship with Regional Sales Manager that enables collaborative efforts to be utilized.§  Develops strong relationships with key decision makers at multiple levels.§  Is proficient in knowledge of Endo products and of competitive products and positioning.§  Responsible for demonstrating knowledge of target customers, competitive accounts, new growth opportunities and time and territory management; submitting reports to RSM consistently on a weekly basis.§  Implements key marketing strategies, business objectives, and treatment/practice growth plans.§  Develops a working territory business plan that includes account segmentation, forecasting, marketing initiatives, and sales execution strategies (i.e. staff training pull through plans, in-office events, etc.).§  Develops and coordinates physician training programs, practice enhancement in-services, and patient events.§  Demonstrates and provide technical product and procedure expertise.§  Completes all assigned paperwork in a timely and accurate manner (i.e. expense reports, business plans, etc.).§  Ensures individual and Company compliance with all federal, state, and local laws, and all company policies and procedures Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree or equivalent experience within an aesthetic medical practice·       5+ years successful medical/dental/device sales or a combination of Business to Business and medical/dental/device and sales·       Demonstration of sustained, high performance (President’s Club, Circle of Excellence or equivalent top sales award) ·       New product launch and/or experience capitalizing on new market opportunities·       Medical aesthetic industry experience (preferred)KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Experience and knowledge of general marketing principles and concepts within an aesthetic or other relevant medical practice§  Experience and knowledge of inner workings of a physician’s practice§  Strong knowledge of the aesthetic market in the assigned territory§  Consultative selling skills and/or B2B selling experience in the aesthetic medical space§  Strong customer service focus and ability to effectively communicate value propositions§  Successful experience with KOL identification and developmentSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  High level of business acumen§  Proven consultative selling skills§  Strong analytical skills§  High customer service orientation with a sense of urgency to respond to the needs of the customer§  Strong conflict and problem resolution skills§  Ability to develop key strategies at the account level and effectively execute§  Strong interpersonal skills§  Strong negotiating skills§  Financial/budgetary experience§  Highly organized and able to prioritize effectively§  Strong presentation, verbal and written communication skills§  Proficiency with Excel, Word, PowerPoint and other software skills§  Ability to travel as required by specific territories§  High aptitude for learning, coaching, and situational awareness§  Ability to work independently and collaborativelyPhysical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Overnight travel may be required Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Remote, Texas
Description Job Summary - a concise overview of the job Endo Aesthetics is an exciting new affiliate of Endo International focused on providing physicians and their patients with expanded choices in medical aesthetic treatments and procedures. We are seeking a passionate, driven Aesthetic Business Manager (ABM) to launch a new and innovative cellulite treatment to the market. The ABM will be responsible for prospecting customers in the medical aesthetic market, providing product information/clinical data, facilitating training, in-practice marketing and sharing appropriate information regarding Endo Aesthetics. The ABM will develop new accounts in the defined geographic territory while meeting and exceeding established sales quotas. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Endo Aesthetics Business Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of Time §  Accountable for meeting or exceeding assigned sales objectives on a monthly, quarterly and annual basis.§  Develops quarterly, monthly and weekly plans designed to maximize customer relationships and improve face-to-face selling time in assigned territory.§  Communicates initial strategy for all new pipeline opportunities and works with Regional Sales Manager (RSM) on how to advance all such opportunities through the sales cycle.§  Communicates and monitors all opportunities in a timely fashion and with a sense of urgency.§  Delivers tangible near term actions with a vision to longer-term sustainable revenues across company offerings.§  Through active listening and questions, understands and has the ability to influence the customer's decision-making process and leads the customer to positive decisions.§  Demonstrates strong customer service focus and ability to effectively communicate value propositions.§  Develops and maintains a strong relationship with Regional Sales Manager that enables collaborative efforts to be utilized.§  Develops strong relationships with key decision makers at multiple levels.§  Is proficient in knowledge of Endo products and of competitive products and positioning.§  Responsible for demonstrating knowledge of target customers, competitive accounts, new growth opportunities and time and territory management; submitting reports to RSM consistently on a weekly basis.§  Implements key marketing strategies, business objectives, and treatment/practice growth plans.§  Develops a working territory business plan that includes account segmentation, forecasting, marketing initiatives, and sales execution strategies (i.e. staff training pull through plans, in-office events, etc.).§  Develops and coordinates physician training programs, practice enhancement in-services, and patient events.§  Demonstrates and provide technical product and procedure expertise.§  Completes all assigned paperwork in a timely and accurate manner (i.e. expense reports, business plans, etc.).§  Ensures individual and Company compliance with all federal, state, and local laws, and all company policies and procedures Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree or equivalent experience within an aesthetic medical practice·       5+ years successful medical/dental/device sales or a combination of Business to Business and medical/dental/device and sales·       Demonstration of sustained, high performance (President’s Club, Circle of Excellence or equivalent top sales award) ·       New product launch and/or experience capitalizing on new market opportunities·       Medical aesthetic industry experience (preferred)KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Experience and knowledge of general marketing principles and concepts within an aesthetic or other relevant medical practice§  Experience and knowledge of inner workings of a physician’s practice§  Strong knowledge of the aesthetic market in the assigned territory§  Consultative selling skills and/or B2B selling experience in the aesthetic medical space§  Strong customer service focus and ability to effectively communicate value propositions§  Successful experience with KOL identification and developmentSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  High level of business acumen§  Proven consultative selling skills§  Strong analytical skills§  High customer service orientation with a sense of urgency to respond to the needs of the customer§  Strong conflict and problem resolution skills§  Ability to develop key strategies at the account level and effectively execute§  Strong interpersonal skills§  Strong negotiating skills§  Financial/budgetary experience§  Highly organized and able to prioritize effectively§  Strong presentation, verbal and written communication skills§  Proficiency with Excel, Word, PowerPoint and other software skills§  Ability to travel as required by specific territories§  High aptitude for learning, coaching, and situational awareness§  Ability to work independently and collaborativelyPhysical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Overnight travel may be required Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Malvern, Pennsylvania
Description Job Summary - a concise overview of the job The Senior Director, Medical Information and Scientific Communication is responsible for leading strategic planning for Medical Information (MI) and Scientific Communication business processes and business system optimization and ensures efficiency and effectiveness of the respective teams. The Senior Director is a member of the Medical Affairs Leadership Team and works closely with all functions in Medical Affairs to optimize efficiency, effectiveness and compliance.  Directly manages the Head of the Call Center, Medical Information (MI), and Scientific Communication. This role is responsible for the overall vision and strategy of the Medical Information function including the Call Center. This role helps ensure the MI function is optimized to provide timely information to HCPs and patients.  The role will ensures seamless relevant data dissemination to Pharmacovigilance, Quality, Legal, Compliance and relevant stakeholders in a compliant manner.  This role also ensures that 2nd line questions (not able to be handled immediately by the Call Center) are answered with the highest quality and speed by the accountable staff. In addition, this role ensures that senior staff is prepared, as well as ensuring timely and high-quality review of promotional materials and support final approval of MI scientific writing assets. This role is responsible for overall management and execution of the therapeutic area publication plans. This role is expected to contribute significantly to identifying the strategic objectives for each therapeutic area as well as identifying the optimal channels for communication of data by thorough understanding of the therapeutic area publications and societies where such data are presented/published. The Senior Director will develop strategic objectives to support appropriate use of Endo products and communicate information within Medical Affairs and other Endo functions in order to better understand experiences with Endo products. The position will also oversee and manage an internal MI team, Scientific Communication team providing guidance and decision making for Endo initiatives. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.This position oversees the processes and policies within Medical Affairs and those that intersect Medical Affairs and other departments within and outside of R&D.  Effective and continuous collaboration with Commercial, Compliance, Legal, and Finance is required.  Is responsible to ensure the Head of the Call Center’s daily oversight meets with Medical Information vision and strategy. Is responsible to provide leadership for establishing publication strategies, development of publication plans and implementation of publication-related projects.  Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of Time Medical InformationCall Centers§  Provide strategic oversight of external customer Call Center activities to ensure compliant and efficient processes are followed.§  Ensure policies and procedures allow for information flows from internal and external sources to facilitate the dissemination of accurate, timely, consistent, and balanced information to internal and external customers.o   Customers include external healthcare professionals, internal Endo personnel, and sometimes consumers/patients.§  Work independently yet ensure strategic alignment of information with key internal stakeholders and experts, as necessary.§  Ensure policies and procedures allow for research, review, and approved scientific research and responses to customer inquiries.§  Ensure policies and procedures allow for effective and compliant response to unexpected events (e.g. product recalls, changes in FDA guidance’s) as well as Quality complaints25%Medical Information§  Ensure policies and procedures allow for the proactive complaint development of medical response documents, creation of customized responses, and revision/update existing documents in database.§  Ensure that review and approval of scientific medical response documents, written by colleagues in the department, occurs in a high-quality, quick and complaint manner.§  Ensure, when required, review and approval of product-related branded and/or non-branded material intended for promotional purposes, including any product-related material developed for internal sales training, reimbursement material, and any information intended to be disseminated outside Endo.§  Develop and implement policies, practices and procedures.§  Oversee the strategy of plans to assist in successful product launches, manage integration of new products§  Assist in education of staff and internal partners on therapeutic areas of interest, product characteristics as needed.35%Scientific Communications§  Responsible for the development of publications strategic plan supporting Endo sponsored studies, as well as those conducted collaboratively with external researchers and clinical practitioners.§  Ensures timely development and implementation of the therapeutic area publication plans.§  Ensure that communication needs are met by linking knowledge gaps to data generated to fill those gaps.§  Identify strategic objectives for each therapeutic area as well as identifying the optimal channels for communication of data by thorough understanding of the therapeutic area and societies where such data is presented/published.§  Responsible to develop and implement quality control measures as needed to ensure accuracy of data to be communicated.40%Total100%  QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Pharm.D., MD or PhD, with Medical Information, Scientific Communication experience required and a minimum 10 years of experience in pharmaceutical industry.§  People Management skills required.§  Medical writing/editing experience for scientific/medical journals.§  Management of agency vendors and writers.§  Budget development and management.KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Knowledge of Medical Information and Scientific Communication processes and industry standards.§  ICMJE Guidelines, Good Publications Practice, PhRMA code GCP, ICH guidelines knowledge and eCTD requirements.§  Knowledge of federal regulations pertaining to the fair and balance promotion of medicines.§  Strong knowledge and ability to master multiple therapeutic areas§  Strong biomedical literature evaluation skills.§  Computer literacy is required (MS OFFICE).§  Knowledge of inquiry response management systems or capabilities.§   Excellent verbal, written, and overall communication skills.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Experience supporting a pharmaceutical company medical information, scientific communication team and/or managing a medical information call center.§  Leadership skills, creating a vision and successfully meeting goals.§  Ability to manage and mentor medical information and call center staff.§  Customer-oriented approach and ability to effectively work in cross-functional teams.§   Ability to prioritize and manage completion of multiple deliverables simultaneously with high quality and professionalism as well as set priorities for team.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§   Up to 10% overnight travel. Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Field, Pennsylvania
Description Job Summary - a concise overview of the job Endo Aesthetics is an exciting new affiliate of Endo International focused on providing physicians and their patients with expanded choices in medical aesthetic treatments and procedures. We are seeking a passionate, driven Aesthetic Business Manager (ABM) to launch a new and innovative cellulite treatment to the market. The ABM will be responsible for prospecting customers in the medical aesthetic market, providing product information/clinical data, facilitating training, in-practice marketing and sharing appropriate information regarding Endo Aesthetics. The ABM will develop new accounts in the defined geographic territory while meeting and exceeding established sales quotas. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Endo Aesthetics Business Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of Time §  Accountable for meeting or exceeding assigned sales objectives on a monthly, quarterly and annual basis.§  Develops quarterly, monthly and weekly plans designed to maximize customer relationships and improve face-to-face selling time in assigned territory.§  Communicates initial strategy for all new pipeline opportunities and works with Regional Sales Manager (RSM) on how to advance all such opportunities through the sales cycle.§  Communicates and monitors all opportunities in a timely fashion and with a sense of urgency.§  Delivers tangible near term actions with a vision to longer-term sustainable revenues across company offerings.§  Through active listening and questions, understands and has the ability to influence the customer's decision-making process and leads the customer to positive decisions.§  Demonstrates strong customer service focus and ability to effectively communicate value propositions.§  Develops and maintains a strong relationship with Regional Sales Manager that enables collaborative efforts to be utilized.§  Develops strong relationships with key decision makers at multiple levels.§  Is proficient in knowledge of Endo products and of competitive products and positioning.§  Responsible for demonstrating knowledge of target customers, competitive accounts, new growth opportunities and time and territory management; submitting reports to RSM consistently on a weekly basis.§  Implements key marketing strategies, business objectives, and treatment/practice growth plans.§  Develops a working territory business plan that includes account segmentation, forecasting, marketing initiatives, and sales execution strategies (i.e. staff training pull through plans, in-office events, etc.).§  Develops and coordinates physician training programs, practice enhancement in-services, and patient events.§  Demonstrates and provide technical product and procedure expertise.§  Completes all assigned paperwork in a timely and accurate manner (i.e. expense reports, business plans, etc.).§  Ensures individual and Company compliance with all federal, state, and local laws, and all company policies and procedures Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree or equivalent experience within an aesthetic medical practice·       5+ years successful medical/dental/device sales or a combination of Business to Business and medical/dental/device and sales·       Demonstration of sustained, high performance (President’s Club, Circle of Excellence or equivalent top sales award) ·       New product launch and/or experience capitalizing on new market opportunities·       Medical aesthetic industry experience (preferred)KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Experience and knowledge of general marketing principles and concepts within an aesthetic or other relevant medical practice§  Experience and knowledge of inner workings of a physician’s practice§  Strong knowledge of the aesthetic market in the assigned territory§  Consultative selling skills and/or B2B selling experience in the aesthetic medical space§  Strong customer service focus and ability to effectively communicate value propositions§  Successful experience with KOL identification and developmentSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  High level of business acumen§  Proven consultative selling skills§  Strong analytical skills§  High customer service orientation with a sense of urgency to respond to the needs of the customer§  Strong conflict and problem resolution skills§  Ability to develop key strategies at the account level and effectively execute§  Strong interpersonal skills§  Strong negotiating skills§  Financial/budgetary experience§  Highly organized and able to prioritize effectively§  Strong presentation, verbal and written communication skills§  Proficiency with Excel, Word, PowerPoint and other software skills§  Ability to travel as required by specific territories§  High aptitude for learning, coaching, and situational awareness§  Ability to work independently and collaborativelyPhysical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Overnight travel may be required Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Field, Maine
Description Job Summary - a concise overview of the job Endo Aesthetics is an exciting new affiliate of Endo International focused on providing physicians and their patients with expanded choices in medical aesthetic treatments and procedures. We are seeking a passionate, driven Aesthetic Business Manager (ABM) to launch a new and innovative cellulite treatment to the market. The ABM will be responsible for prospecting customers in the medical aesthetic market, providing product information/clinical data, facilitating training, in-practice marketing and sharing appropriate information regarding Endo Aesthetics. The ABM will develop new accounts in the defined geographic territory while meeting and exceeding established sales quotas. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Endo Aesthetics Business Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of Time §  Accountable for meeting or exceeding assigned sales objectives on a monthly, quarterly and annual basis.§  Develops quarterly, monthly and weekly plans designed to maximize customer relationships and improve face-to-face selling time in assigned territory.§  Communicates initial strategy for all new pipeline opportunities and works with Regional Sales Manager (RSM) on how to advance all such opportunities through the sales cycle.§  Communicates and monitors all opportunities in a timely fashion and with a sense of urgency.§  Delivers tangible near term actions with a vision to longer-term sustainable revenues across company offerings.§  Through active listening and questions, understands and has the ability to influence the customer's decision-making process and leads the customer to positive decisions.§  Demonstrates strong customer service focus and ability to effectively communicate value propositions.§  Develops and maintains a strong relationship with Regional Sales Manager that enables collaborative efforts to be utilized.§  Develops strong relationships with key decision makers at multiple levels.§  Is proficient in knowledge of Endo products and of competitive products and positioning.§  Responsible for demonstrating knowledge of target customers, competitive accounts, new growth opportunities and time and territory management; submitting reports to RSM consistently on a weekly basis.§  Implements key marketing strategies, business objectives, and treatment/practice growth plans.§  Develops a working territory business plan that includes account segmentation, forecasting, marketing initiatives, and sales execution strategies (i.e. staff training pull through plans, in-office events, etc.).§  Develops and coordinates physician training programs, practice enhancement in-services, and patient events.§  Demonstrates and provide technical product and procedure expertise.§  Completes all assigned paperwork in a timely and accurate manner (i.e. expense reports, business plans, etc.).§  Ensures individual and Company compliance with all federal, state, and local laws, and all company policies and procedures Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree or equivalent experience within an aesthetic medical practice·       5+ years successful medical/dental/device sales or a combination of Business to Business and medical/dental/device and sales·       Demonstration of sustained, high performance (President’s Club, Circle of Excellence or equivalent top sales award) ·       New product launch and/or experience capitalizing on new market opportunities·       Medical aesthetic industry experience (preferred)KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Experience and knowledge of general marketing principles and concepts within an aesthetic or other relevant medical practice§  Experience and knowledge of inner workings of a physician’s practice§  Strong knowledge of the aesthetic market in the assigned territory§  Consultative selling skills and/or B2B selling experience in the aesthetic medical space§  Strong customer service focus and ability to effectively communicate value propositions§  Successful experience with KOL identification and developmentSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  High level of business acumen§  Proven consultative selling skills§  Strong analytical skills§  High customer service orientation with a sense of urgency to respond to the needs of the customer§  Strong conflict and problem resolution skills§  Ability to develop key strategies at the account level and effectively execute§  Strong interpersonal skills§  Strong negotiating skills§  Financial/budgetary experience§  Highly organized and able to prioritize effectively§  Strong presentation, verbal and written communication skills§  Proficiency with Excel, Word, PowerPoint and other software skills§  Ability to travel as required by specific territories§  High aptitude for learning, coaching, and situational awareness§  Ability to work independently and collaborativelyPhysical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Overnight travel may be required Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Rochester, Michigan
Description Supervisor, Manufacturing Quality Assurance, Quality Assurance Operations, Michigan-Rochester About Endo International plcEndo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA, employing approximately 3,000 people worldwide.  For 2018 Endo, reported revenue of $2.947B and adjusted diluted EPS of $2.89.  Learn more at www.endo.com. POSITION SUMMARY: The Supervisor, under limited management, ensures compliance with cGMP and company  policies/procedures/ specifications. Oversees Specialists, ensuring manufacturing ops conform to established procedures / regulatory requirements. Ensures timely completion of batch record reviews and audits manufacturing areas. Interfaces with Quality Management Systems including but not limited to TrackWise, Maximo and inventory mgt. Writes/evaluates/approves quality investigations, corrective and preventive actions (CAPA), SOPs, and protocols. Leads teams to develop/implement Continuous Improvement within dept and across site. Assist in troubleshooting manufacturing problems and inspection/packaging defects. Make improvements in cGMP standards, implement new quality initiatives; assist in reviewing/ approving cGMP documentation.QA Mfg responsibilities for a single site. ROLE AND RESPONSIBILITIES: Quality Assurance ManagementPerforms on-line auditing in Inspection and Packaging (AQL checks) or Mfg when necessary.Assists and supports Sterile Filling, Bulk Mfg, Inspection & Packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.Assists MQA Specialists in solving compliance errors when detected during processes.Participates in or leads Cross Functional Investigations as assigned by upper management. Make effective decisions in a timely manner and be focused on execution until completion.Recognizes problems within scope of job; promptly communicates to management.Follows directions and demonstrates proper judgment when a deviation occurs.Provides QA oversight in mfg ops to ensure product/facilities comply with SOPs/policies/cGMPs.Participates in resolving deviations and implementing CAPA.Independently manages simple to complex discrepancies.Key Quality contact for manufacturing discrepancy mgt, batch review, and line support.Performs assigned tasks and work to achieve company goals and department objectives.Leads or participates in and provides leadership for projects as designated by upper mgmt.Recognizes trends, deviations, problems and promptly reports them to management.Schedules floor/area coverage to meet production needs.Reviews and approves master batch records supporting commercial & clinical production as well as validation protocols and reports for equipment requalification or IQ/OQ/PQ.Multitasks and manages competing priorities while meeting production timelines.Represents Quality Assurance at meetings. Documentation & SOPsReviews batch record documentation included but not limiting to bulk, sterile filling, inspection, packaging and components to ensure compliance with SOPs and policies.Participates in development, authoring and/or review of SOPs/policies to support QA ops. ComplianceEnforces quality standards and process controls.Leads or responds to, quality audits when applicable to assure conformance with regulatory and internal requirements.  Has the skills necessary to conduct own internal audits.Works in timely, safe manner conforming to regulatory, co. and compendial requirements.Provides direct manufacturing QA support during internal/external regulatory inspections. Staff DevelopmentSupervises/trains QA staff at various levels, such as in-process, sampling, product release etc.Monitors employee performance, provides feedback, conducts performance reviews, develop and administer enhancement plans, and follow-up on personnel issues where necessary.Provides and designs group performance metrics.Develops personal performance goals and group objectives.Oversees the qualification and requalification of personnel. REQUIRED QUALIFICATIONS: Education & ExperienceBS/BA degree in Chemistry, Life Science, or related field from an accredited college or University.7+ yrs pharma exp. with 2+ yrs supervisory experience in cGMP/pharma environment or equivalent. Equivalent combinations of education and experience will be considered.Experience in Sterile Injectable facility preferred.Experienced in training techniques.Experience in sterile product, quality assurance, quality control or packaging operations.   KnowledgeProficient with manufacturing operations and quality procedures to comply with regulations.Maintains a working knowledge of government and industry Quality standards.Solid understanding and use of ANSI sampling techniques and principles.Intermediate principles of mathematical and statically computations.Must have proficiency in cGMP/GLP, GLP, CFR, ISO and USP practices in a FDA regulated environment.  Must have SOP, investigation, and project protocol writing skills Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.Must have an understanding of cGMPs, Prior experience with regulatory (FDA) inspections. Skills & AbilitiesAble to analyze and troubleshoot problems. Able to effectively handle conflict/resolution situations between different departments and inter-department.Must have good verbal and written communication skillsAbility to interpret quality standards for implementation including ability to manage systems or processes. Ability to make sound decisions about scheduling, allocation of resources, managing priorities and work hours.  Ability to lead moderate to complex projects or systems. PHYSICAL REQUIREMENTS: Extended periods of sitting, standing, walking; reach with hands/arms; climb or balance; stoop, kneel, crawl; talk or hear; taste or smell, looking at monitor, moderate noise levels; some bus. travel. Work in cGMP environment.ADDITIONAL INFORMATION: Afternoon shift premium is 10% (non-union positions only)Midnight shift premium is 15% (non-union positions only)  Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.  Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled *LI-ENDP 
Endo Pharmaceuticals / Par Pharmaceutical Chestnut Ridge, New York
Description Company Website Analytical R&D Scientist II – Chestnut Ridge, NY: Perform analytical method validations/verifications under moderate supervision for raw materials and finished products. Write/review analytical test methods, validation/verification protocols, and reports. Troubleshoot OOS results. Conduct routine and non-routine laboratory analyses such as raw materials, finished product testing, stability testing, and manufacturing in-process testing, which requires critical levels of accuracy. Analyze and interpret results in written and oral format in consultation with supervisor/project leaders. Follow all SOPs and Safety Guidelines and work in compliance with cGMP/cGLP regulations. Maintain R&D lab as a GMP-compliant and safe working environment. Ensure notebooks reviewed in a timely manner, in accordance with SOPs. Review laboratory notebooks, raw data and testing results to ensure accurate documentation if required. Document analytical data under cGMP and corporate guidelines. Provide general lab support: routine instrument cleaning/preventive maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping. Keep the training record related to the job functions up to date and make sure one receive proper training before performing any tests. Applicant must have a Master Degree in Pharmaceutical Science or Pharmaceutical Manufacturing. Must have 2 years of experience working as research an Associate in a Pharmaceutical Company handling laboratory functions. Must have experience in HPLC and GC based analytical methods: assay, Chiral Purity, Residual Solvents, Dissolution, Water Content FTIR; Operating, Calibrating, Troubleshooting HPLC, GC, UV/VIS, Dissolution Apparatus, FTIR, and Karl Fischer Titrator, PH Meter and Analytical Balance. Must have experience of working in compliance with SOP, CGMP, FDA, ICH, DEA, OSHA and DEA Regulations, MSDS, USP, EP and JP. 40 hours per week, M-F 9:00am-5:00pm. Must have proof of legal authority to work in the United States. Mail resumes to HR at Par Pharmaceutical, 6 Ram Ridge Road, Chestnut Ridge, NY 10977. Job Ref. #20190315.
Endo Pharmaceuticals / Par Pharmaceutical Irvine, California
Description Manager, Procurement, Supply Chain, Irvine, CA About Par Pharmaceutical: Par Pharmaceutical, headquartered in Chestnut Ridge, NY, develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patient quality of life. Par, among the top leaders in the U.S. generics industry, possesses a portfolio that includes sterile injectables, alternative dosage forms and many other differentiated products. Par is advancing a robust research and development (R&D) pipeline of potential products.  Par is an operating company of Endo International plc (NASDAQ: ENDP), a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients through excellence in development, manufacturing and commercialization. Learn more at www.endo.com or www.parpharm.com. POSITION SUMMARY:The Manager, Procurement is responsible for managing and centralizing the procurement of all supplies for the site for commercial purposes with the exception of API. The role works cross-functionally within the assigned site to execute strategies, gain alignment, drive cost reduction and streamline inventories in house.  Source all key supplies for the site and manage excipients and consumables for targeted or potentially targeted products identified for internal use.ROLE AND RESPONSIBILITIES:Keep abreast of the market and provide market intelligence to management on potential opportunities meeting the criteria for introduction of alternative suppliers.Maintain knowledge of market pricing for key chemical entities to maintain competitive edge within the market. Identify price discrepancies noted between Endo’s source and market pricing, work with related group to identify alternate sources.Provide support through commercial product life cycle. Ensure that all groups and/or partners have the data and materials they need within the timeframe needed.  Follow the Companies guidelines for JDE/SAP and Finance when placing orders or creating vendor/item numbers.  Assist Supply Chain with transition of project once nearing launch timeline.Assess potential opportunities that may yield potential savings and overall improvement.Manage assigned category spend.Manage the day-to-day purchasing operations at the site (but not limited to) including GMP items, consumables, and all site supplies to support all departments.Centralize all procurement activities for the site.Provide support through commercial product life cycle.Ensure that all groups and/or partners have the data and materials to support on time and quality PAS filings.Assist Supply Chain with transition of project post filing.Conduct employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of staff.Hire, train, and manage performance of staff.Set goals and objectives for individuals and teams.Delegate work duties to individual staff members.Special projects as assigned/directed by Associate Director of Supply Chain. REQUIRED QUALIFICATIONS:Bachelor’s degree or equivalent in a scientific or other related discipline.10+ years’ related work experience within the pharmaceutical industry working closely with R&D, Business Development and Manufacturing or an equivalent overall level of knowledge based upon previous work experience.Purchasing experience in the pharmaceutical area; sterile and ophthalmic experience a plus.People management experience a plus.Strong background in Pharmaceutical Ingredients’ Sourcing.Strong knowledge of key manufacturers/suppliers and associated specialties.Maintain knowledge of market pricing for key chemical entities to maintain competitive edge within the market.Understanding of the generic market, competitive landscape and legal environment as it pertains to R&D API procurement.Knowledge of computer systems and software applications.Work independently and manage multiple complex projects, and execute strategic plans.Strong analytical negotiation, communication, contract execution and project management skills.Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.PHYSICAL REQUIREMENTS:Limited domestic and international travel required. Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required. Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Endo Pharmaceuticals / Par Pharmaceutical Remote, Texas
Description Job Summary - a concise overview of the job Endo Aesthetics is an exciting new affiliate of Endo International focused on providing physicians and their patients with expanded choices in medical aesthetic treatments and procedures. We are seeking a passionate, driven Aesthetic Business Manager (ABM) to launch a new and innovative cellulite treatment to the market. The ABM will be responsible for prospecting customers in the medical aesthetic market, providing product information/clinical data, facilitating training, in-practice marketing and sharing appropriate information regarding Endo Aesthetics. The ABM will develop new accounts in the defined geographic territory while meeting and exceeding established sales quotas. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Endo Aesthetics Business Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of Time §  Accountable for meeting or exceeding assigned sales objectives on a monthly, quarterly and annual basis.§  Develops quarterly, monthly and weekly plans designed to maximize customer relationships and improve face-to-face selling time in assigned territory.§  Communicates initial strategy for all new pipeline opportunities and works with Regional Sales Manager (RSM) on how to advance all such opportunities through the sales cycle.§  Communicates and monitors all opportunities in a timely fashion and with a sense of urgency.§  Delivers tangible near term actions with a vision to longer-term sustainable revenues across company offerings.§  Through active listening and questions, understands and has the ability to influence the customer's decision-making process and leads the customer to positive decisions.§  Demonstrates strong customer service focus and ability to effectively communicate value propositions.§  Develops and maintains a strong relationship with Regional Sales Manager that enables collaborative efforts to be utilized.§  Develops strong relationships with key decision makers at multiple levels.§  Is proficient in knowledge of Endo products and of competitive products and positioning.§  Responsible for demonstrating knowledge of target customers, competitive accounts, new growth opportunities and time and territory management; submitting reports to RSM consistently on a weekly basis.§  Implements key marketing strategies, business objectives, and treatment/practice growth plans.§  Develops a working territory business plan that includes account segmentation, forecasting, marketing initiatives, and sales execution strategies (i.e. staff training pull through plans, in-office events, etc.).§  Develops and coordinates physician training programs, practice enhancement in-services, and patient events.§  Demonstrates and provide technical product and procedure expertise.§  Completes all assigned paperwork in a timely and accurate manner (i.e. expense reports, business plans, etc.).§  Ensures individual and Company compliance with all federal, state, and local laws, and all company policies and procedures Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree or equivalent experience within an aesthetic medical practice·       5+ years successful medical/dental/device sales or a combination of Business to Business and medical/dental/device and sales·       Demonstration of sustained, high performance (President’s Club, Circle of Excellence or equivalent top sales award) ·       New product launch and/or experience capitalizing on new market opportunities·       Medical aesthetic industry experience (preferred)KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Experience and knowledge of general marketing principles and concepts within an aesthetic or other relevant medical practice§  Experience and knowledge of inner workings of a physician’s practice§  Strong knowledge of the aesthetic market in the assigned territory§  Consultative selling skills and/or B2B selling experience in the aesthetic medical space§  Strong customer service focus and ability to effectively communicate value propositions§  Successful experience with KOL identification and developmentSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  High level of business acumen§  Proven consultative selling skills§  Strong analytical skills§  High customer service orientation with a sense of urgency to respond to the needs of the customer§  Strong conflict and problem resolution skills§  Ability to develop key strategies at the account level and effectively execute§  Strong interpersonal skills§  Strong negotiating skills§  Financial/budgetary experience§  Highly organized and able to prioritize effectively§  Strong presentation, verbal and written communication skills§  Proficiency with Excel, Word, PowerPoint and other software skills§  Ability to travel as required by specific territories§  High aptitude for learning, coaching, and situational awareness§  Ability to work independently and collaborativelyPhysical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Overnight travel may be required Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Malvern, Pennsylvania
Description Job Summary - a concise overview of the jobThe Data Management Director is an influential leader responsible for the global Data Management strategy for all studies, Programs, Phases and therapeutic areas. Provides day to day leadership for Data project management, medical coding, data systems and quality, and is accountable for the implementation of Program and study data strategies and overall project delivery. Is the key point person for operational excellence in partnership with Biostatistics, Clinical, Statistical Programming, and other Development functions. Ensures that adequate resourcing is available internally and externally through strategic partnerships to meet milestones and performance/quality requirements across all drug programs. Partners within R&D to ensure strategy is aligned, partners with Biostatistics and Clinical Operations to ensure excellence in all aspects of statistical trial data acquisition and reporting as well as other functions within R&D, including Drug Safety, Regulatory, R&D Compliance, to collaborate on work streams and initiatives that impact all of R&D. Supports Early Clinical Development through Late Stage Development by ensuring that Data Management processes, standards, templates and best practices are applied fit for purpose to meet Endo Program needs. Manages, coaches, and supports staff in order to develop excellence. The Data Management Director role requires a thorough understanding of clinical data, efficiencies in guiding its collection, oversight of its management and assurance of its integrity in the clinical trial process.  Responsible for qualifying and managing external service providers and for managing internal data management staff and/or in-house consultants. This position is responsible directly or through oversight of external service providers for the development, implementation and maintenance of appropriately validated systems/applications for clinical data management, and for providing data management support for clinical trials. This position is responsible for the development of data acquisition standards and practices with keen attention to quality and regulatory compliance.  Participates in clinical trial planning efforts as key contact for data acquisition and delivery. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.§  Plan, budget and coordinate finances and timeline for the purpose of project related EDC set-up, support, training, and Data Management services.§  Ensure consistent interpretation and use of Endo standards across projects.§  Define and initiate scope of projects with external vendors and review cost, schedule, and performance; oversight of external service providers. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeLead Data Management Activities in Development and Execution of Clinical Trials§  Oversee day to day activities of data managers working on studies within a program§  Participate in Clinical Development taskforces and initiatives around standardization and technology, as needed§  Serve as an active member of Study Teams§  Work with other functions to manage timelines and ensure that clinical data management deadlines are met§  Liaise with third-party vendors such as CROs and central laboratories in support of timelines and data-related deliverables§  Work with database builders to develop EDC databases, edit checks and reports§  May define database and edit check specifications to support the protocol and analyses§  May develop UAT requirements for new study databases and revisions§  Participate in database testing in accordance with UAT Plan§  Create and maintain data management documentation§  Regularly review and query clinical trial data as indicated in the Data Validation Specifications and Integrated Data Review Plan§  Help design listings in support of data management, clinical and medical reviews of data§  Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics, audit reports, and input from project team members and other stakeholders§  Train other personnel on study-related items and data management principles, as needed§  Ensure coordination with Pharmcovigilance on adverse event reconciliation§  Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required§  Participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities§  Help develop Data Management standards§  Train and/or supervise the daily responsibilities of more junior staff as assigned100%  100%    QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s Degree with 10 years in the pharmaceutical/clinical research industry.§  5 - 7 years of experience in Data Management in the pharmaceutical/clinical research industry with experience in a managerial role (projects/personnel).§  Ability to direct and manage the activities of outside Data Management vendors.§  Familiarity with SAS dataset structure.KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Knowledge of current and emerging trends in data management of clinical trial data.§  Knowledge of the drug development process.§  Knowledge and understanding of the principles, concepts, methods and standards of Clinical Data Management (CDM).§  Knowledge of regulations related to CDM and clinical research such as GCP, ICH Guidance, 21 CFR, CDISC and SDTM data model.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Proficient computer skills across multiple applications such as word processing, spreadsheet and presentation software.§  Skills in the use of SAS programming, database management, external data streams (e.g. EDC, IWRS, ePro, central labs).§  CRF design/database design/data review skills.§  Attention to detail.§  Verbal and written communication skills.§  Interact effectively with a wide variety of internal personnel and outside vendors.§  Ability to identify new or changing business needs and take actions to meet them.§  Results driven and solution seeking.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Office Environment Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Field, South Carolina
Description Job Summary - a concise overview of the job Endo Aesthetics is an exciting new affiliate of Endo International focused on providing physicians and their patients with expanded choices in medical aesthetic treatments and procedures. We are seeking a passionate, driven Aesthetic Business Manager (ABM) to launch a new and innovative cellulite treatment to the market. The ABM will be responsible for prospecting customers in the medical aesthetic market, providing product information/clinical data, facilitating training, in-practice marketing and sharing appropriate information regarding Endo Aesthetics. The ABM will develop new accounts in the defined geographic territory while meeting and exceeding established sales quotas. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Endo Aesthetics Business Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of Time §  Accountable for meeting or exceeding assigned sales objectives on a monthly, quarterly and annual basis.§  Develops quarterly, monthly and weekly plans designed to maximize customer relationships and improve face-to-face selling time in assigned territory.§  Communicates initial strategy for all new pipeline opportunities and works with Regional Sales Manager (RSM) on how to advance all such opportunities through the sales cycle.§  Communicates and monitors all opportunities in a timely fashion and with a sense of urgency.§  Delivers tangible near term actions with a vision to longer-term sustainable revenues across company offerings.§  Through active listening and questions, understands and has the ability to influence the customer's decision-making process and leads the customer to positive decisions.§  Demonstrates strong customer service focus and ability to effectively communicate value propositions.§  Develops and maintains a strong relationship with Regional Sales Manager that enables collaborative efforts to be utilized.§  Develops strong relationships with key decision makers at multiple levels.§  Is proficient in knowledge of Endo products and of competitive products and positioning.§  Responsible for demonstrating knowledge of target customers, competitive accounts, new growth opportunities and time and territory management; submitting reports to RSM consistently on a weekly basis.§  Implements key marketing strategies, business objectives, and treatment/practice growth plans.§  Develops a working territory business plan that includes account segmentation, forecasting, marketing initiatives, and sales execution strategies (i.e. staff training pull through plans, in-office events, etc.).§  Develops and coordinates physician training programs, practice enhancement in-services, and patient events.§  Demonstrates and provide technical product and procedure expertise.§  Completes all assigned paperwork in a timely and accurate manner (i.e. expense reports, business plans, etc.).§  Ensures individual and Company compliance with all federal, state, and local laws, and all company policies and procedures Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree or equivalent experience within an aesthetic medical practice·       5+ years successful medical/dental/device sales or a combination of Business to Business and medical/dental/device and sales·       Demonstration of sustained, high performance (President’s Club, Circle of Excellence or equivalent top sales award) ·       New product launch and/or experience capitalizing on new market opportunities·       Medical aesthetic industry experience (preferred)KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Experience and knowledge of general marketing principles and concepts within an aesthetic or other relevant medical practice§  Experience and knowledge of inner workings of a physician’s practice§  Strong knowledge of the aesthetic market in the assigned territory§  Consultative selling skills and/or B2B selling experience in the aesthetic medical space§  Strong customer service focus and ability to effectively communicate value propositions§  Successful experience with KOL identification and developmentSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  High level of business acumen§  Proven consultative selling skills§  Strong analytical skills§  High customer service orientation with a sense of urgency to respond to the needs of the customer§  Strong conflict and problem resolution skills§  Ability to develop key strategies at the account level and effectively execute§  Strong interpersonal skills§  Strong negotiating skills§  Financial/budgetary experience§  Highly organized and able to prioritize effectively§  Strong presentation, verbal and written communication skills§  Proficiency with Excel, Word, PowerPoint and other software skills§  Ability to travel as required by specific territories§  High aptitude for learning, coaching, and situational awareness§  Ability to work independently and collaborativelyPhysical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Overnight travel may be required Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Field, New Jersey
Description Job Summary - a concise overview of the job Endo Aesthetics is an exciting new affiliate of Endo International focused on providing physicians and their patients with expanded choices in medical aesthetic treatments and procedures. We are seeking a passionate, driven Aesthetic Business Manager (ABM) to launch a new and innovative cellulite treatment to the market. The ABM will be responsible for prospecting customers in the medical aesthetic market, providing product information/clinical data, facilitating training, in-practice marketing and sharing appropriate information regarding Endo Aesthetics. The ABM will develop new accounts in the defined geographic territory while meeting and exceeding established sales quotas. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Endo Aesthetics Business Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of Time §  Accountable for meeting or exceeding assigned sales objectives on a monthly, quarterly and annual basis.§  Develops quarterly, monthly and weekly plans designed to maximize customer relationships and improve face-to-face selling time in assigned territory.§  Communicates initial strategy for all new pipeline opportunities and works with Regional Sales Manager (RSM) on how to advance all such opportunities through the sales cycle.§  Communicates and monitors all opportunities in a timely fashion and with a sense of urgency.§  Delivers tangible near term actions with a vision to longer-term sustainable revenues across company offerings.§  Through active listening and questions, understands and has the ability to influence the customer's decision-making process and leads the customer to positive decisions.§  Demonstrates strong customer service focus and ability to effectively communicate value propositions.§  Develops and maintains a strong relationship with Regional Sales Manager that enables collaborative efforts to be utilized.§  Develops strong relationships with key decision makers at multiple levels.§  Is proficient in knowledge of Endo products and of competitive products and positioning.§  Responsible for demonstrating knowledge of target customers, competitive accounts, new growth opportunities and time and territory management; submitting reports to RSM consistently on a weekly basis.§  Implements key marketing strategies, business objectives, and treatment/practice growth plans.§  Develops a working territory business plan that includes account segmentation, forecasting, marketing initiatives, and sales execution strategies (i.e. staff training pull through plans, in-office events, etc.).§  Develops and coordinates physician training programs, practice enhancement in-services, and patient events.§  Demonstrates and provide technical product and procedure expertise.§  Completes all assigned paperwork in a timely and accurate manner (i.e. expense reports, business plans, etc.).§  Ensures individual and Company compliance with all federal, state, and local laws, and all company policies and procedures Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree or equivalent experience within an aesthetic medical practice·       5+ years successful medical/dental/device sales or a combination of Business to Business and medical/dental/device and sales·       Demonstration of sustained, high performance (President’s Club, Circle of Excellence or equivalent top sales award) ·       New product launch and/or experience capitalizing on new market opportunities·       Medical aesthetic industry experience (preferred)KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Experience and knowledge of general marketing principles and concepts within an aesthetic or other relevant medical practice§  Experience and knowledge of inner workings of a physician’s practice§  Strong knowledge of the aesthetic market in the assigned territory§  Consultative selling skills and/or B2B selling experience in the aesthetic medical space§  Strong customer service focus and ability to effectively communicate value propositions§  Successful experience with KOL identification and developmentSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  High level of business acumen§  Proven consultative selling skills§  Strong analytical skills§  High customer service orientation with a sense of urgency to respond to the needs of the customer§  Strong conflict and problem resolution skills§  Ability to develop key strategies at the account level and effectively execute§  Strong interpersonal skills§  Strong negotiating skills§  Financial/budgetary experience§  Highly organized and able to prioritize effectively§  Strong presentation, verbal and written communication skills§  Proficiency with Excel, Word, PowerPoint and other software skills§  Ability to travel as required by specific territories§  High aptitude for learning, coaching, and situational awareness§  Ability to work independently and collaborativelyPhysical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Overnight travel may be required Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Irvine, California
Description Instrument Calibration & Repair Technician, Engineering Services, Irvine, CA About Par Pharmaceutical: Par Pharmaceutical, headquartered in Chestnut Ridge, NY, develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patient quality of life. Par, among the top leaders in the U.S. generics industry, possesses a portfolio that includes sterile injectables, alternative dosage forms and many other differentiated products. Par is advancing a robust research and development (R&D) pipeline of potential products.  Par is an operating company of Endo International plc (NASDAQ: ENDP), a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients through excellence in development, manufacturing and commercialization. Learn more at www.endo.com or www.parpharm.com. POSITION SUMMARY:Working from blueprints, written or verbal instructions, installs, inspects, assembles, troubleshoots, repairs, adjusts, and calibrates control and regulating instrumentation, weighing equipment, testing equipment, and electronic communication equipment such as measuring devices, meters and gauges, electrical and electronic controls, plant paging equipment, etc., at levels that support uninterrupted manufacturing operations and current Good Manufacturing Practices.  Essential duties includes:Performs calibrations, assuring traceability to the National Institute of Standards and Technology (N.I.S.T.) on instruments and weighing equipment and controls located throughout the plant.Maintains calibration records in accordance with Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Standard Operating Procedures (SOPs).Installs, repairs, replaces, adjusts and/or aligns critical process instrumentation, weighing equipment, and laboratory instrumentation.Installs, troubleshoots, and maintains sensors, data gathering panels, wiring, and ancillary devices which make up the plant-wide Building Automation System (BAS).Supports maintenance and calibration activities within a single site.Maintains the following relationships on a regular basis:Inside the Company:- Production Line Supervisors                        daily- Manufacturing Engineers                            daily- Project Engineers                                         daily- Laboratory Supervisors                               daily     - Maintenance Supervisors                            daily Outside the Company:- Contractors                                                  daily- Vendors                                                        weekly- Metrology Standards References                as required ROLE AND RESPONSIBILITIES:Configures, constructs, and maintains electrical/electronic testing instrumentation.Assists in the review of calibration and maintenance procedures to assure accuracy and pertinence.Maintains and calibrates weighing equipment (laboratory balances, floor scales, etc.) located in all areas of the plant.Troubleshoots, maintains, repairs, and calibrates process instrumentation and controls located throughout the facility.Completes documentation required for calibrations, planned maintenance work, and line utilization logs.Utilizes hand tools and instrumentation in a safe manner.Maintains a clean and safe job-site at all times.Communicates all work related activities to production supervisors.Assists other trades when possible.Utilizes drawings and schematics for installation and troubleshooting.Operates Company vehicles for transportation of equipment with the facility or public highways.Participates in safety training programs.  QUALIFICATIONS:Required Qualifications:Bachelor’s degree or completion of electronics technical school with 5+ years of experience in calibration and repair of process instrumentation or 5+ military/pharma experience in TMDE, instrumentation or metrology. Preferred Qualifications:5+ years of experience in the pharmaceutical manufacturing business with extensive knowledge of GMP’s.Training in computer technology, electronic data acquisition systems, manufacturing automation equipment, test measurement and diagnostic equipment training and PLC technology.Experience with laboratory analytical instrumentation, computer technology, electronic data acquisition systems, manufacturing automation equipment, and PLC technology. Experience with performing maintenance in a heavily regulated industry.Knowledge of technical equipment and mechanical ability to interact with the equipment.cGMP, FDA, EU, GLP compliance knowledge, training and understanding.Knowledge of all Microsoft office applications.Basic written communications for SOP development and protocol development. Proficient with the following types of machines & equipment:Power and hand toolsLaddersRegulating instrumentationPrecision measuring standardsManufacturing process equipmentHighway vehicles, i.e., automobiles and trucksIn-plant transport vehicles, i.e., scootersConfined space entry equipmentRespirators and other personal protective equipment  PHYSICAL REQUIREMENTS:Must regularly abide by the following safety considerations: Confined Space Entry Training, Lockout/Tagout Training, Ladder Safety, Respirator Fit Testing, Electrical Safety Training, Personal Protective EquipmentMust be able to navigate the following working conditions: Clean Room Gowning, Confined spaces, Machine rooms, Shop areas, Powerhouse, Manufacturing areas, Laboratories, Clean room, Rooftops and catwalks Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required. Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled