Job Overview
Leadership and Strategy:
- Lead and manage the medical writing team, providing mentorship, guidance, and performance feedback to ensure the successful execution of all writing projects.
- Collaborate closely with senior leadership, clinical development, regulatory affairs, and other functional departments to align medical writing strategies with overall clinical development goals.
- Develop and implement writing standards, templates, and processes to ensure high-quality, compliant, and consistent document delivery.
- Ensure that medical writing activities comply with regulatory guidelines, industry standards, and internal procedures.
Document Creation and Review:
- Oversee the preparation of key regulatory and clinical documents, including clinical trial protocols, investigator brochures, briefing books, clinical study reports (CSRs), and clinical sections of IND/CTA/NDAs/BLAs.
- Ensure medical writing deliverables are completed on time and meet the highest scientific, regulatory, and quality standards.
- Provide oversight and editing support for team members responsible for authoring manuscripts, abstracts, posters, and other scientific communications.
Regulatory Submissions and Support:
- Lead medical writing efforts for regulatory submissions (e.g., IND, NDA, BLA) and ensure alignment with regulatory requirements and guidelines (FDA, EMA, ICH).
- Partner with regulatory affairs to review and refine documents in preparation for regulatory filings, ensuring accurate presentation of clinical data and trial results.
- Participate in the development and review of responses to regulatory agency questions and comments.
Collaboration and Communication:
- Communicate effectively with internal and external stakeholders to manage expectations, resolve issues, and ensure alignment on document timelines and content.
- Provide training and guidance to internal teams on best practices for medical writing and regulatory documentation.
Team Development and Oversight:
- Lead and mentor a team of medical writers, supporting their development and career growth.
- Establish performance metrics and key performance indicators (KPIs) to track the successful execution of medical writing deliverables.
- Foster a culture of continuous improvement within the medical writing team.
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 related field will also be considered with relevant experience.
