Job Summary
As a key member of the cross-functional Development Team responsible for providing regulatory writing expertise and leadership to formulate the writing strategy for key regulatory documents for submission, the Sr. Director, Head of Regulatory & Medical Writing will guide the medical and regulatory writing group (contractors and internal writers) to ensure high-quality deliverables. The role collaborates with Clinical Scientists, Medical Monitors, Regulatory and other functional groups to ensure scientific excellence in the execution of clinical trials and builds a medical writing group when appropriate. Reporting to the SVP, Head of Regulatory Affairs, this role drives regulatory and medical writing deliverables on time and to quality standards.
Responsibilities
* Ensure appropriate allocation of internal and external resources needed for all regulatory writing deliverables.
* Hire and manage medical writers internally and oversee external medical writing contractors.
* Forecast and maintain budget for the regulatory writing team.
* Assess efficiencies, identify areas for improvement, and initiate improvement processes.
* Coordinate, author, and edit documents supporting clinical trial conduct and reporting, including but not limited to:
o Clinical study protocols and protocol amendments (in partnership with Clinical Science/Clinical Development)
o Clinical study reports
o Investigator's brochures and annual updates
o IND submissions and annual reports
o Lay‐person summary
o Integrated summary reports
o Clinical, Nonclinical and Multidisciplinary Information Amendments
o NDA, BLA, MAA, (e)CTD submissions
o Risk Management Plans
o Health Authority responses
o Briefing Documents, ODDs, BTDs/PRIME, FTD, etc.
* Participate in relevant subteam(s) and ensure effective planning and management of timelines for all components of assigned documents across projects.
* Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
* Support and develop deliverables required for global transparency and disclosure, such as plain‐language lay summaries and regulatory document redactions for EU posting regulations; partner with Biometrics to develop standard TFLs and text tables for deliverables.
* Maintain and review standard processes and templates.
* Review and edit documents as required.
* Work effectively and lead in cross‐functional working groups.
Qualifications
* Candidates must have a BS with 15+ years of experience, or an MS/advanced science degree (e.g., RN, NP, MSN, PharmD, PhD, MD) with 10+ years of oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical/biotech industry.
* Prior experience leading a regulatory writing group.
* Experience writing or leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA).
* Proficiency in computer software (word processing, graphics, reference manager, document management systems).
* Familiarity with all drug development phases, clinical study protocol design, CTA/IND submissions, investigator's brochures, and clinical study data collection and reporting.
* Advanced knowledge of routine document content preparation, including style guides, medical dictionaries, and regulatory guidance documents/templates.
* Experience writing protocols (Phase 1–3 oncology), investigator's brochures, clinical study reports, Health Authority briefing packages, and responses. Pediatric Investigational Plan (PIP) experience is preferred.
* Advanced understanding of regulatory requirements, GCP, and guidelines associated with regulatory documents.
* Ability to interpret and summarize complex tabular and graphical data presentations.
* Strong organizational, documentation, and communication skills with the ability to multitask.
* Adaptable and flexible, willing to adjust to multiple demands and shifting priorities; able to meet day‐to‐day challenges with confidence and professionalism.
* Detailed knowledge of GCP, ICH Guidelines, and current US FDA regulations.
Salary Range
$254,127 - $289,388 plus bonus and equity.
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