Principal Medical Writer
$169,500–$201,500 year
Hybrid · San Diego, California, United States
San Diego, California, United StatesHybridFull Time$169,500–$201,500 yearSenior LevelBachelors DegreeUnknown
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
Lead authoring and editing of clinical and regulatory documents to support regulatory submissions (INDs/CTAs/BLAs/NDAs/MAAs), including protocols, IBs, CSRs, and promotional/poster materials; manage document review and approvals; mentor writers; collaborate with contractors and vendors; apply AI/tools and document-management systems; contribute to manuscripts and cross-functional initiatives; travel between Pasadena and San Diego offices as needed.
Required Qualifications
- Bachelor's degree in physical science, life science, or health-related field such as biology, chemistry, or nursing
- at least 8 years coordinating, authoring, and editing protocols, IBs, CSRs, and other clinical regulatory documents in a pharmaceutical company or CRO environment supporting submissions to U.S. and/or EU health authorities
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