Role OverviewServe as functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities.
What You Will Do
Author or oversee the authoring of all regulatory submission documents, conduct formal review and approval of authored documents, lead regulatory writing activities for complex product submissions, and supervise the work of contract and freelance writers.
Why It Might Be a Fit
We are looking for a leader with a doctorate degree and 2 years of directly related experience, or equivalent qualifications.
Requirements
- Doctorate degree and 2 years of directly related experience
- Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
- 5+ years of experience in medical writing in the Biotech/Pharmaceutical industry
Benefits
- Comprehensive employee benefits package
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models
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