Director, Medical Writing

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Provide strategic guidance and hands-on execution for the creation of high-quality, compliant clinical and regulatory documents that support development programs.

• Collaborate with Clinical Development, Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Research, Preclinical, Translational Biomarkers, Program Management, and Medical Affairs.

• Oversee the planning, authorship, review, and finalization of documents for submissions to the FDA and global health authorities.

• Manage both internal and external medical writing resources to ensure timely delivery of accurate, high-quality documents.

• Write, edit, and collaborate on protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and other related submission materials.

• Review and enhance documents prepared by contributors for quality, consistency, scientific accuracy, and regulatory compliance.

• Contribute to project planning and participate in cross-functional working groups.

• Establish and refine medical writing processes, templates, and best practices.

⛳️ Requirements

• A Bachelor’s degree in life sciences or a related field is required; an advanced degree is preferred.

• Over 10 years of medical writing experience in the pharmaceutical or biotechnology sectors.

• Extensive experience in authoring and reviewing clinical and regulatory documents.

• Capability to lead strategic discussions that ensure alignment of content and messaging across submissions.

• Exceptional communication skills to effectively influence cross-functional stakeholders.

• Experience in managing both internal and external medical writing resources, including vendors, consultants, and cross-functional contributors.

• Proficiency in writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents.

• Strong knowledge of FDA and international regulations, ICH guidelines, and regulatory processes, including CTD requirements.

• Experience in developing and implementing medical writing strategies across programs, submissions, or therapeutic areas.

• Proficient in Microsoft Office, Adobe Acrobat, and shared document management systems such as SharePoint.

• Ability to prioritize, manage multiple projects simultaneously, and produce high-quality work within tight deadlines.

• In-depth understanding of the requirements for clinical, nonclinical, and regulatory documents supporting INDs, CTAs, annual reports, and related submissions.

• Strong attention to detail, accuracy, and consistency.

• Ability to synthesize, analyze, and present complex clinical and scientific data clearly and accurately.

• Self-motivated, proactive, and effective in problem-solving within a dynamic, cross-functional environment.

• Strong collaboration skills and the ability to integrate input from multiple contributors into submission-ready documents.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• Retirement savings plan with company matching.

• Opportunities for professional development and continuing education.

• Flexible work arrangements and a supportive work environment.