Director, Medical Writing

Company Overview:

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 .

Role Summary:

The Associate Director, Medical Writing is responsible for the timely preparation of high quality, compliant clinical and regulatory documents. This position is responsible for the medical writing activities for one or more clinical programs and will interact with other functions (eg, clinical development, clinical operations, clinical pharmacology, research, preclinical, biomarkers, program management, and medical affairs) as necessary. This position will function with limited supervision as required and ensures deliverables are of high quality and completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals.

Previous experience in authoring and reviewing clinical, nonclinical, and regulatory documents is desired. The ability to lead strategic discussions to ensure aligned messaging throughout regulatory documentation is critical. Outstanding communication skills are a must.

This role is based in Waltham, MA with hybrid work flexibility.

Primary Responsibilities Include:

Writes, edits, and collaborates with program team members on a variety of regulatory documents including protocols, investigator brochures, clinical study reports, CTDs, and briefing books

Reviews, edits, and ensures quality of documents or sections of documents prepared by functional area representatives as required and ensures adherence to standards

Oversees document review comment resolution meetings

Contributes to overall project management and to cross-functional working groups as needed to facilitate efficient development and finalization of clinical and regulatory documents for submissions

Supports the development of best practices for authoring and reviewing, with a focus on continuous process improvement

Education and Skills Requirements:

Minimum of a Bachelor’s degree (advanced degree preferred) in Life Sciences, or related discipline, with a solid understanding of the basic principles of biochemistry and molecular biology

Minimum 5 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company

Competence in writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents per company and other guidelines

Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)

Proficiency with typical office applications (eg, Microsoft Office, Adobe Acrobat) and in shared document systems (eg, SharePoint, Veeva)

Ability to work independently: prioritize tasks, problem solve, and complete high-quality documents under aggressive timelines

Aptitude for compilation, analysis, and presentation of data

Ability to work with multiple contributors to produce a final unified document

Commitment to accuracy and detail-oriented work

  The pay range displayed below is the range of base pay compensation within which the company expects to pay for this role at the time of this posting. Individual compensation depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

Salary Range $194,000 — $213,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

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.