Director Medical Writing

Overview

The Director, Medical Writing will provide Medical Writing leadership for drug development programs, collaborate with project teams on the strategy and development of clinical documents including clinical document submissions to global regulatory agencies, and provide Medical Writing leadership and oversight within Medical Writing.

Key Responsibilities

• Lead the Medical Writing efforts and strategy on drug development programs and ensure high quality and on-time writing deliverables in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs), including clinical protocols, amendments, investigator brochures, clinical study reports, summaries of biopharmaceutics, clinical pharmacology, clinical safety, and clinical efficacy, clinical overviews, and related documents.
• Directly oversee, develop, and manage medical writers on multiple programs; provide leadership, coaching, guidance, and mentorship; ensure management and training of external writers/CROs.
• Communicate program goals and priorities to the medical writers on assigned drug development programs.
• Plan, coordinate, oversee, and drive clinical filing dossiers with colleagues from the Filing Excellence group.
• Independently plan, write, and edit high-quality and on-time writing deliverables, as needed.
• Contribute to the development of global department standards (including templates, style guides, and related processes) and implementation of process improvements.
• Collaborate with Medical Writing leadership to ensure proper planning and resourcing for upcoming project writing deliverables.
• Partner effectively with Data Sciences and Statistics, Clinical Operations, Clinical Development, Regulatory Affairs, Global Patient Safety and Risk Management, Early Development, Program Management, Research, and Quality, as well as with external stakeholders.
• Serve as subject matter expert for Research and Development documents and their production, including clinical document strategies within the drug development program.

Qualifications

• Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred.
• 10 years of experience as a medical writer in the sponsor/CRO setting. Sponsor experience strongly preferred.
• Experience with leading, planning, writing, coordinating, and overseeing the clinical dossier for global regulatory filings (NDA/BLA/MAA) required. CTA/IND experience is a plus.
• 3 years of experience as a successful manager of medical writing direct reports
• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
• Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
• Impeccable attention to detail and ability to complete writing assignments in a timely manner with minimal oversight.
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
• Demonstrate clear alignment with Alnylam Core Values including,
• Commitment to People
• Fiercely Innovative
• Purposeful Urgency
• Open Culture
• Passion for Excellence.