Senior Director, Head of Regulatory & Medical Writing

Job Summary
- Provide regulatory writing expertise and leadership to formulate writing strategy for key regulatory documents for submission.
- Guide medical/regulatory writing group (contractors and internal writers), ensuring appropriate work allocation and document preparation; provide review and substantive editing to deliver high-quality documents.
- Collaborate cross-functionally (Clinical Scientists, Medical Monitors, Regulatory, other functions; clinical medical writing as applicable) to ensure scientific excellence in execution of clinical trials.
- Own regulatory writing & medical writing deliverables for assigned project(s) per timelines and quality standards (reporting to SVP, Head of Regulatory Affairs).

Responsibilities
- Allocate internal/external resources for regulatory writing deliverables.
- Hire/manage medical writers; manage external writing contractors.
- Forecast/maintain regulatory writing team budget; assess efficiencies and initiate improvements.
- Coordinate, author, and edit clinical trial conduct/reporting documents, including protocols/amendments, clinical study reports, investigator’s brochures/updates, IND submissions/annual reports, lay summaries, integrated summary reports, clinical/nonclinical/multidisciplinary amendments, NDA/BLA/MAA/(e)CTD submissions, Risk Management Plans, health authority responses, and briefing packages/ODDs/BTDs (e.g., PRIME/FTD).
- Plan/manage timelines for document components; contribute to document strategy (messaging, flow, logic, consistency).
- Support global transparency/disclosure deliverables (e.g., plain language lay summaries; EU posting/redactions; EU CTR results); partner with Biometrics on standard TFLs/text tables.
- Maintain/review standard processes and templates; lead cross-functional working groups.

Qualifications
- BS with 15+ years, or MS/advanced degree (e.g., RN, NP, MSN, PharmD, PhD, MD) with 10+ years oncology clinical research experience as clinical/regulatory medical writer in pharma/biotech.
- Prior experience leading a regulatory writing group.
- Experience authoring/leading critical clinical documents in major regulatory filings (NDA/BLA/MAA).
- Proficiency with software (word processing, graphics, reference manager, document management systems).
- Familiarity with discovery-to-market drug development and clinical protocol design; CTA/IND submissions; investigator’s brochures; data/results reporting.
- Advanced knowledge of routine document content prep (style guides, medical dictionaries, regulatory guidance/templates).
- Experience with protocols (Phase 1–3 oncology), investigator’s brochures, clinical study reports, health authority briefing packages, and health authority responses; Pediatric Investigational Plans (PIPs) preferred.
- Advanced understanding of regulatory requirements, GCP, and guidelines for regulatory documents; ability to interpret complex tabular/graphical data; strong organization/documentation/communication; multitasking; adaptable.

Salary Range
- $254,127–$289,388 plus bonus and equity.