Manager to Associate Director Regulatory Medical Writing

Manager to Associate Director Regulatory Medical Writing

San Francisco Bay Area- MUST be on-site

Permanent (relocation candidates okay)

 

Responsibilities

• Proven experience writing regulatory documents including CSRs, CTD Summaries, Investigative Brochures ect
• Ability to lead in depth Medical Writing projects while concurrently managing the work of other medical writers
• Regulatory writing SME for project teams; main point of contact for cross-functional groups
• Works cross-functionally with contributors such as Clinical Operations and Biometrics Departments to ensure accuracy of data while adhering to project timelines

 

Qualifications

• Bachelor degree REQUIRED, advanced degree highly preferred
• Significant experience within Regulatory Affairs Medical writing in Pharma/Biotech
• Minimum of 5 years of medical writing of documents for regulatory submissions