Manager, Content Strategy and Development (Medical Writing)- Oncology
$146,540–$189,640 year
On-siteFoster City, California, United States
Job Summary
Prepare clinical documentation for global regulatory submissions, including clinical study reports, protocols, amendments, and investigator brochures according to regulatory requirements and Gilead internal standards. Author integrated clinical summaries, pediatric investigation plans, and regulatory responses while collaborating with cross-functional teams in Regulatory Affairs, Clinical Research, and Clinical Operations. Manage document timelines and resource planning, participate in regulatory submission teams to guide optimal data presentation, and contribute to the development of document standards, templates, and processes. Lead document strategy for Medical Writing within the Oncology focus area.
Required Qualifications
- 6+ years of relevant experience
- BS/BA
- 4+ years of relevant experience with MA/MAS/MPH/MBA
- 2+ years of relevant experience with PharmD/PhD or equivalent
- The ability to understand the needs of a team and manage their expectations and use various communication styles to work effectively with teams
- The ability to balance integrity and efficiency when managing attention to detail
- Knowledge of regulatory document requirements/guidelines
- Proficiency in the use of Microsoft Office and document management systems
- Relevant experience includes clinical research and development, regulatory affairs, or related industry/academic experience
- Direct experience preparing clinical/regulatory documents in a medical writing/clinical submissions environment
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