Director, Medical Writing

Role Summary:

The Associate Director, Medical Writing is responsible for the timely preparation of high quality, compliant clinical and regulatory documents. This position is responsible for the medical writing activities for one or more clinical programs and will interact with other functions (eg, clinical development, clinical operations, clinical pharmacology, research, preclinical, biomarkers, program management, and medical affairs) as necessary. This position will function with limited supervision as required and ensures deliverables are of high quality and completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals.

Previous experience in authoring and reviewing clinical, nonclinical, and regulatory documents is desired. The ability to lead strategic discussions to ensure aligned messaging throughout regulatory documentation is critical. Outstanding communication skills are a must.

This role is based in Waltham, MA with hybrid work flexibility.

Primary Responsibilities Include:

• Writes, edits, and collaborates with program team members on a variety of regulatory documents including protocols, investigator brochures, clinical study reports, CTDs, and briefing books
• Reviews, edits, and ensures quality of documents or sections of documents prepared by functional area representatives as required and ensures adherence to standards
• Oversees document review comment resolution meetings
• Contributes to overall project management and to cross-functional working groups as needed to facilitate efficient development and finalization of clinical and regulatory documents for submissions
• Supports the development of best practices for authoring and reviewing, with a focus on continuous process improvement

Education and Skills Requirements:

• Minimum of a Bachelor’s degree (advanced degree preferred) in Life Sciences, or related discipline, with a solid understanding of the basic principles of biochemistry and molecular biology
• Minimum 5 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company
• Competence in writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents per company and other guidelines
• Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
• Proficiency with typical office applications (eg, Microsoft Office, Adobe Acrobat) and in shared document systems (eg, SharePoint, Veeva)
• Ability to work independently: prioritize tasks, problem solve, and complete high-quality documents under aggressive timelines
• Aptitude for compilation, analysis, and presentation of data
• Ability to work with multiple contributors to produce a final unified document
• Commitment to accuracy and detail-oriented work