Director, Medical Writing
- Experience
- Lead
- Employment
- Full-time
Open to US only. Set where you work from to check your eligibility.
No BS summary
Director of Medical Writing needed for a biotech company developing therapeutics for neuromuscular diseases. Requires 10+ years of medical writing experience in pharma/biotech, with a strong focus on clinical and regulatory documents for FDA/global health authority submissions. Must have deep experience authoring, editing, and reviewing key submission documents and possess exceptional communication skills to lead strategic discussions and influence stakeholders.
Core skills
Required skills
Required languages
What you'll do
- Lead the planning, authoring, review, and completion of clinical and regulatory documents required for submissions to the FDA and other global health authorities
- Manage internal and external medical writing resources to deliver accurate, high-quality documents on time and in accordance with established standards
- Author, edit, and collaborate with cross-functional team members on key documents, including protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials
- Review and refine documents or document sections prepared by functional contributors to ensure quality, consistency, scientific accuracy, and adherence to company and regulatory standards
- Contribute to project planning and cross-functional working groups to support efficient development, review, approval, and finalization of submission-ready documents
- Establish and continuously improve medical writing processes, templates, and best practices to increase quality, consistency, and operational efficiency
What they require
- Bachelor’s degree in life sciences or a related discipline required; advanced degree preferred, with a strong understanding of biochemistry and molecular biology principles
- 10+ years of medical writing experience in the pharmaceutical or biotechnology industry, with significant experience preparing clinical and regulatory documents
- D eep experience authoring and reviewing clinical and regulatory documents
- Ability to lead strategic discussions that align content and messaging across submissions
- Exceptional communication skills to influence cross-functional stakeholders
- Experience overseeing internal and external medical writing resources, including vendors, consultants, and cross-functional contributors
- Demonstrated expertise writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents
- Strong understanding of FDA and international regulations, ICH guidelines, and regulatory processes related to document preparation, production, and submission, including CTD requirements
- Experience developing and executing medical writing strategy across programs, submissions, or therapeutic areas
- Highly organized, with the ability to prioritize, manage multiple projects simultaneously, and deliver high-quality work under tight timelines
- 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-directed, proactive, and effective at problem solving in a fast-paced, cross-functional environment
- Strong collaboration skills, with the ability to integrate input from multiple contributors into clear, cohesive, submission-ready documents
Benefits
- Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .