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 be responsible for providing guidance to the medical and or regulatory writing group (contractors and internal writers) assigned to deliverables and ensuring appropriate work allocation and document preparation.; will also provide review and substantive editing of documents to ensure delivery of high-quality documents. This individual will work effectively with many other functional groups, including with Clinical Scientist(s), Medical Monitors, Regulatory and other functions as applicable, and collaborate with clinical medical writing as applicable to ensure scientific excellence in the execution of clinical trials. The Head of Regulatory Writing will build a medical writing group internally when appropriate.
Reporting to the SVP, Head of Regulatory Affairs, this role will be responsible for the regulatory writing & medical writing deliverables of assigned project(s), in accordance with the agreed timelines and quality standards.
Responsibilities:
- Ensure appropriate allocation of internal and external resources needed for all regulatory writing deliverables.
- Hire and manage medical writers internally and manage external medical writing contractors.
- Forecasting and maintaining budget for the regulatory writing team.
- Assess efficiencies, help identify areas of improvement and initiate improvement processes.
- Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to:
- Clinical study protocols and clinical protocol amendments (in partnership with Clinical Science/Clinical Development)
- Clinical study reports
- Investigator's brochures and annual updates
- IND submissions and annual reports
- Lay-person summary
- Integrated summary reports
- Clinical, Nonclinical and Multidisciplinary Information Amendments
- NDA, BLA, MAA, (e)CTD submissions
- Risk Management Plans
- Health Authority responses
- 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 all 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 requirements (e.g., plain language lay summary, applicable redactions to regulatory documents subject to EU posting regulations and results for EU CTR).Partner with Biometrics in developing standard TFLs and in text tables for deliverables as applicable
- Maintain and support developing and reviewing 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, or MS or other advanced science degree (e.g.: RN, NP, MSN, PharmD, PhD, MD) with 10+ years of experience in 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/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA).
- Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, document management systems.
- Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator's brochures and clinical study data collection and results reporting.
- Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
- Experience writing, at a minimum, protocols (Phase 1-3, in oncology), investigator's brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Pediatric Investigational Plans (PIPs) is preferred.
- Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
- Ability to interpret and summarize complex tabular and graphical data presentations.
- Strong organization, documentation and communication skills with an ability to multitask.
- Adaptable / flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
- Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
