About this role
Job Description
Responsibilities include:
- Lead and direct all aspects of critical writing activities, working cross-functionally to develop and produce high-quality deliverables such as clinical study protocols, IBs, CSRs, INDs/CTDs/amendments, analysis and development plans, safety updates and annual reports, narratives/summaries, briefing books, and additional Research/Pre-Clinical/CMC, Clinical and Regulatory documents in support of our programs.
- In partnership with cross-functional teams, critically analyze and interpret non-clinical and clinical data (internal and external) to develop crucial strategy, conclusions, and messaging. As needed, perform literature and scientific database searches in support of analyses and development of background summaries.
- Participate on teams as a key thought leader to develop strategy and approach, ensuring consistency and efficiency with how messaging and documents are built and organized, contributing scientific knowledge and analytical skills.
- Build a scalable medical and scientific writing infrastructure, with an emphasis on resourcing, that includes developing formats, templates, processes and standards, style