Summary:
The Director of Medical Writing will act as the leader of the medical writing staff at a leading biotechnology research center focused on oncology. They will write and edit clinical study reports (CSRs) and common technical documents (CTD) summaries for regulatory submission while providing guidance and leadership to junior writers. If you are a medical writer looking to step into a leadership role at a leading oncology research company, please see below.
The Director of Medical Writing will be responsible for:
- Writing and editing clinical trial documents as necessary, including CSRs and CTDs, for submission to regulatory agencies, including but not limited to, the FDA
- Guiding and supervising junior-level staff, as well as consultant medical writers on document preparation as needed.
- Assembles CSR and CTD summary appendices and narratives
- Creating and editing Clinical Protocols and Investigator Brochures drafts as well as summarizing and analyzing data from statistical tables and other sources.
- Proposes and manages timelines for document preparation and review
- Being the contact person for regular and ad hoc project teams and/or guiding junior medical writers to do so.
The Director of Medical Writing should have the following qualifications:
- Bachelor's degree in a related discipline and a minimum of 13 years related experience OR
- Master's degree in a related discipline and a minimum of 11 years related experience OR
- PhD in a related discipline and a minimum of 8 years related experience
- 12 years of relevant experience with preferred experience in biotech/pharmaceutical industries
- Experience and significant participation in preparation of documents for regulatory submissions (e.g., clinical protocols, INDs, NDAs, BLAs, CTDs) is essential.
- Specific oncology experience is necessary.
- Leads or manages the work of junior staff by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing
If you are interested in the Director of Medical Writing role, then please don't wait to apply!
