The Director, Medical Writing will focus primarily on scientific medical writing, which includes, writing and editing of protocols, investigator brochures, clinical study reports and annual reports. Must have strong project management experience along with in-depth knowledge of the clinical development process. This is an in-house opportunity in South San Francisco.
Provides leadership, planning and project management to ensure the completion of key documents (e.g. Investigator's Brochures, DSURs, clinical protocols, clinical study reports (CSRs), and clinical summary documents (such as integrated summaries of efficacy and safety), using data provided and in a format compliant with the governing regulatory agency.
Use scientific expertise to write, review, and edit reports such as the clinical protocol, investigator brochure, clinical study report, informed consent, risk/benefit analysis and integrated summary and annual reports.
Ensures key messages are clear and consistent across and within documents and contributes strategically and scientifically at the program level.
Manages external and internal medical writing resources and needs
B.S. or Advanced degree with 10+ years of experience.
Demonstrated in-depth knowledge of clinical regulatory documentation requirements (familiar with GCP, CTD, FDA, and ICH requirements).
Demonstrated ability to successfully manage multiple projects from conception to completion, working collaboratively in a team environment.
Demonstrated experience in the preparation of protocols, study reports, investigator brochures, safety updates, and Regulatory documents, including IND and NDA submissions