Director, Global Medical Writing

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

📋 Description

• Act as the primary writer for clinical programs and submissions within the clinical pipeline.

• Independently compose and oversee clinical study-related documents, which include clinical study protocols, master protocols, Investigator’s brochures, and clinical study reports.

• Lead cross-functional teams in the development of regulatory submission documents, regulatory response documents, and IND/CTA or global regulatory submission documents.

• Direct Medical Writing for one or more clinical programs, focusing on the planning, development, and execution of content strategy.

• Serve as a representative for Medical Writing on cross-functional clinical, regulatory, and submission teams.

• Engage in NDA/MAA/IND submission planning and documentation activities.

• Create and oversee clinical documents and assigned tasks, ensuring adherence to established timelines and quality standards.

• Drive document strategies and messaging in collaboration with project-team subject matter experts.

• Stay informed about advancements in medical writing and related technologies.

• Implement process improvements in line with R&D requirements.

• Organize and coordinate work with in-house Medical Writers and external CROs.

• Conduct medical literature searches as needed.

• Take part in company-wide initiatives, such as protocol template working groups and Investigator’s Brochure standardization.

• Review medical writing deliverables, statistical analysis plans, tables, figures, and listings as necessary.

• Manage and mentor 1–2 direct reports, with plans for future oversight of writing across a therapeutic area.

• Report to the Senior Director of Global Medical Writing.

⛳️ Requirements

• Advanced degree (MS or Ph.D.) in a relevant scientific discipline; Ph.D. is preferred.

• A minimum of 8–10 years of experience in medical writing.

• In-depth knowledge and experience in preparing high-quality clinical and regulatory documents.

• Familiarity with clinical trial disclosure requirements.

• Experience in authoring regulatory and clinical documents for global submissions, including NDA, NDS, MAA, and IND submissions across ICH regions.

• Active involvement in the planning and preparation of summary documents.

• Exceptional verbal and written communication skills.

• Strong attention to detail concerning consistency, grammar, syntax, and accuracy.

• Superior organizational and prioritization skills for handling multiple concurrent documents.

• Proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software, MS Office (Teams, Outlook, Word, Excel, PowerPoint, SharePoint), Veeva Vault, and Please Review.

• Experience in oncology, immunology, and/or neurology is highly preferred.

🏝️ Benefits

• Annual performance bonus.

• Long-term incentive plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) retirement plan with company match.

• Generous parental leave.

• Family planning benefits.

• Opportunities for personal and professional growth.