SUMMARY:An emerging biopharmaceutical company is seeking a Senior Director, Medical Writing to lead and oversee the medical writing function across a diverse portfolio of clinical development programs, spanning from early-phase clinical trials to Phase 3 studies. This leadership role entails strategic direction, oversight, and management of regulatory writing activities, including clinical trial protocols, investigator brochures, briefing books, clinical study reports (CSRs), and other key documents essential for regulatory submissions and scientific communication (e.g., DSURs, health authority meeting requests, INDs, etc.).
The position requires strong leadership capabilities, a comprehensive understanding of end-to-end oncology clinical development, and the ability to collaborate across multiple disciplines, including clinical, regulatory, clinical pharmacology, biomarker and translational medicine, and clinical operations. The ideal candidate should be adept at adapting to shifting priorities and regulatory outcomes while thriving in a fast-paced environment with multiple deliverables across various therapeutic areas. A hands-on approach, with the ability to manage individual projects alongside team leadership, is essential. This role reports to the Chief Medical Officer (CMO) for oncology and includes direct reports.
KEY RESPONSIBILITIES:
Leadership and Strategy:
Lead and manage the medical writing team, providing mentorship, guidance, and performance feedback to ensure timely and successful project execution.
Partner with senior leadership, clinical development, regulatory affairs, and other departments to align medical writing strategies with overall clinical development objectives.
Develop and implement best practices, templates, and processes to ensure high-quality, compliant, and consistent documentation.
Ensure that all medical writing activities adhere to regulatory guidelines, industry standards, and internal procedures.
Document Creation and Review:
Oversee the preparation of regulatory and clinical documents, including clinical trial protocols, investigator brochures, briefing books, CSRs, and clinical sections of IND/CTA/NDAs/BLAs.
Ensure timely completion of medical writing deliverables, meeting the highest scientific, regulatory, and quality standards.
Provide editorial oversight and review support for scientific communications, including manuscripts, abstracts, and posters.
Regulatory Submissions and Support:
Lead the development of documents for regulatory submissions (e.g., IND, NDA, BLA) in compliance with relevant regulatory requirements and guidelines (FDA, EMA, ICH).
Collaborate closely with regulatory affairs teams to review and refine documents for regulatory filings, ensuring accurate representation of clinical data and trial outcomes.
Contribute to the preparation and review of responses to regulatory agency queries and feedback.
Collaboration and Communication:
Maintain clear and effective communication with internal and external stakeholders to manage expectations, resolve issues, and ensure alignment on timelines and content.
Provide training and guidance to teams on best practices in medical writing and regulatory documentation.
Team Development and Oversight:
Lead and mentor a team of medical writers, fostering professional growth and development.
Establish performance metrics and key performance indicators (KPIs) to ensure the successful execution of medical writing deliverables.
Cultivate a culture of continuous improvement within the medical writing function.
QUALIFICATIONS:
Education:
Advanced degree (Ph.D., M.D., or Pharm.D.) in a scientific or medical discipline preferred. A Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field will also be considered with relevant experience.
Experience:
Minimum of 10 years of experience in medical writing within the pharmaceutical or biotechnology industry, including at least 5 years in a leadership role.
Extensive experience in writing regulatory documents for clinical trials across all phases (Phase 1 to Phase 3).
Proven expertise in regulatory submissions (IND, NDA, BLA) and a deep understanding of regulatory requirements and guidelines (FDA, EMA, ICH).
Demonstrated experience managing teams, mentoring writers, and working collaboratively with cross-functional teams.
Skills:
Exceptional written and verbal communication skills, with the ability to present complex scientific concepts clearly and concisely.
Strong attention to detail and a commitment to delivering high-quality documentation.
Ability to manage multiple priorities, meet deadlines, and thrive in a dynamic environment.
Proficiency in medical writing software and document management systems.
Strong leadership skills with the ability to inspire, mentor, and guide a team of medical writers.
