Associate Director, Medical Writer
On-site · Westlake Village, California, United States
Job Summary
Medical Writer Associate Director responsible for leading strategic document preparation across INDs, NDAs, and briefing documents, including clinical study protocols, CSRs, DSURS, Investigator Brochures, safety narratives, and manuscripts for peer-reviewed publication. The role coordinates cross-functional teams (clinical development, medical affairs, regulatory affairs, safety) to ensure ICH-GCP-compliant, high-quality scientific writing and timely delivery of regulatory and publication documents. Duties include establishing templates and standards, overseeing document development and finalization, staying current with global regulatory requirements (FDA, EMA, PMDA, ICH), and providing strategic oversight while managing multiple priorities in endocrinology and pulmonology-related projects.”,
Required Qualifications
- BS/BA +12 / MS/MBA 8-10, PhD 5+ years experience as described in job posting
- Degree in science or medical related field. Master’s or PhD preferred.
- Minimum of 7 years relevant industry experience in medical writing in sponsor/CRO setting or academia, or related areas such as quality, regulatory submissions, publications, clinical research, or product support/R&D.
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