Role OverviewWe're seeking an experienced Director of Medical Writing to lead the development of high-quality clinical and regulatory documents across our development programs.
What You Will Do
Lead the medical writing function and oversee clinical and regulatory document development, including protocols, clinical study reports, health authority meeting materials, and submission content.
Why It Might Be a Fit
Strong leadership, communication, and collaboration skills, a strategic mindset with a hands-on approach, and a passion for advancing innovative therapies and delivering high-quality regulatory documentation.
Requirements
- 8+ years of medical writing experience in the biopharmaceutical industry
- Strong experience authoring and managing clinical and regulatory documents across the drug development lifecycle
- Knowledge of FDA, ICH, EMA, and global regulatory requirements
- Experience interpreting clinical data and working with protocols, SAPs, TFLs, safety, and efficacy outputs
- Proven ability to lead vendors and collaborate effectively across multidisciplinary teams
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