Title: Sr Director, Medical Writing
Location: South San Francisco
Status: Hybrid role 3 days a week onsite to start with flexibility thereafter
Compensation: $260,000 to $280,000 per year
We are seeking to add an accomplished, creative and dedicated medical writer to the team. The medical writer will be responsible for writing and overseeing the completion of various regulatory and clinical/nonclinical documents. This person will work with the cross-functional teams to ensure the documents are of high quality, completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, and will oversee all the regulatory and clinical medical writing activities.
Responsibilities
- Build and lead the medical writing department by managing internal and external medical writers and assessing resource needs to meet the organizational goals.
- Establish key document development processes, standards and style guides in collaboration with a cross-functional team.
- Plan and lead submissions of clinical and regulatory documents (e.g., IND/NDA applications, protocols, eCTD clinical/nonclinical summaries/IMPD and briefing books)
- Develop and maintain SOPs relevant to medical writing function.
- Develop and maintain Company standard templates and best review practices for regulatory and clinical documentation; ensure vendors and contractors maintain company standards.
- Ensure smooth and effective document management from template to a final approved version.
- Ensure quality of documents or sections of documents prepared by functional area representatives as required and ensure adherence to standards and style guides.
- Oversee document review and comment resolution meetings with cross-functional teams.
Qualifications
- Bachelor’s degree in a scientific discipline required, advanced degree preferred.
- Minimum of 15 years of relevant clinical and regulatory writing experience; 12 years’ experience with Masters or 10 years’ experience with PhD.
- Minimum of 5 years of management experience.
- Solid understanding of the clinical development process, including the regulatory documentation required at each stage.
- Familiar with eCTD structure, and experience with eCTD summary documents (e.g. Modules 2.5 and 2.7) and/or regulatory briefing documents.
