Director, Medical Writing

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

📋 Description

• Provide strategic direction and hands-on execution for the development 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.

• Ensure that scientific messaging is clear and consistent across submissions to the FDA and global health authorities.

• Oversee the planning, writing, reviewing, and completion of clinical and regulatory submission documents.

• Manage both internal and external medical writing resources to ensure that accurate, high-quality documents are delivered on schedule.

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

• Review and refine 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 enhance medical writing processes, templates, and best practices.

⛳️ Requirements

• A bachelor’s degree in life sciences or a related field is required.

• More than 10 years of medical writing experience in the pharmaceutical or biotechnology sector.

• Extensive experience in preparing clinical and regulatory documents.

• Profound expertise in authoring and reviewing clinical and regulatory documentation.

• Capability to lead strategic discussions that align 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.

• Proficient 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 related to document preparation, production, and submission, including CTD requirements.

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

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

• Ability to prioritize tasks, manage multiple projects concurrently, and deliver high-quality work within tight deadlines.

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

• Ability to synthesize, analyze, and present complex clinical and scientific data in a clear and accurate manner.

• Self-directed, proactive, and capable of effective problem-solving in a fast-paced, cross-functional environment.

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

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible work environment with a focus on work-life balance.

• Supportive and inclusive company culture.