Responsibilities:
- Prepare all clinical and regulatory documents (protocols, protocol amendments, clinical study reports, investigator brochures, IND Reports, and briefing books)
- Responsible for consistency and accuracy of all medical writing content (clarity, style guide, organization, scientific standards, and formatting)
- Serve on cross-functional project teams to manage the review and approval process
- Partner with functional leads to create timelines within the regulatory content life cycle to deliver documentation
Requirements:
- Master's or doctorate degree in life sciences; oncology or infectious disease experience preferred
- 3+ years of writing experience within the biotech/pharmaceutical industry
- Experience authoring, reviewing and approval of clinical and regulatory documents including IND/NDA/MAA and CTD submission documents
- Ability to interpret clinical, statistical, and technical data
We have a current opportunity for a Senior Medical Writer on a permanent basis. The position will be based in South San Francisco CA. For further information about this position please apply.
