Director, Medical Writing

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

📋 Description

• Oversee the planning, creation, review, and finalization of clinical and regulatory documents necessary for submissions to the FDA and other global health authorities.

• Coordinate internal and external medical writing resources to produce precise, high-quality documents within established timelines and standards.

• Write, edit, and work collaboratively with cross-functional team members on essential documents, including protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and other related submission materials.

• Evaluate and enhance documents or sections prepared by functional contributors to guarantee quality, consistency, scientific accuracy, and compliance with company and regulatory standards.

• Participate in project planning and cross-functional working groups to facilitate efficient development, review, approval, and completion of submission-ready documents.

• Develop and continuously refine medical writing processes, templates, and best practices to boost quality, consistency, and operational efficiency.

⛳️ Requirements

• A Bachelor’s degree in life sciences or a related field is required; an advanced degree is preferred, along with a solid understanding of biochemistry and molecular biology principles.

• A minimum of 10 years of medical writing experience within the pharmaceutical or biotechnology sector, with extensive experience in preparing clinical and regulatory documents.

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

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

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

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

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

• A thorough understanding 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.

• Highly organized, capable of prioritizing and managing multiple projects simultaneously, and delivering high-quality work within tight deadlines.

• Detailed knowledge of requirements for key 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 skilled at problem-solving in a fast-paced, cross-functional environment.

• Strong collaboration skills, with the ability to integrate input from various contributors into clear, cohesive, submission-ready documents.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and continuous learning.

• Flexible working hours and the possibility of remote work.

• Supportive and inclusive company culture.