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Director, Medical Writing

Dyne Therapeutics · United States · US

Medical Writing
Remote
Dentist
Demand72
Career growth68
Healthcare fit62
Remote potential80
Salary band
USD 190k – 235k
5-year outlook
Senior medical writing leadership roles in biotech generally offer strong compensation, and demand should remain steady for experienced regulatory and clinical writing professionals. Exact salary will depend on location, company stage, and total compensation package.
Clinical license
Not required
Applicant reach
narrow
Seniority
senior
Employment type
full-time
Date found
2026-11-06

Intelligence details

Flexible work details

Engagement type
Permanent
Hours
Full-time
Eligible countries
United States
Profession fit
Dentist
Rate period
Annual

Listing via Himalayas.

Eligibility, licensing, and location restrictions can change. Always confirm details on the source posting before applying.

Why this is worth applying to

Worth applying only if you have substantial pharma/biotech medical writing and regulatory submission experience, especially in clinical documents such as protocols, CSRs, IBs, and CTD modules. It is not an entry point for clinicians without a medical writing track record.

Who should apply

Physician, pharmacist, or life-sciences advanced-degree professionals with 10+ years of pharmaceutical/biotech medical writing experience and direct FDA/global regulatory submission authorship. Clinicians who have transitioned into regulatory writing, clinical development documentation, or medical communications leadership may be competitive.

CV angle

Frame real clinical, research, and regulatory experience around document authorship and cross-functional leadership: protocols, investigator brochures, clinical study reports, CTD modules, briefing books, FDA/global submissions, ICH/GCP compliance, and collaboration with clinical development, regulatory, and program teams. Emphasize therapeutic-area depth, scientific accuracy, vendor/consultant oversight, and measurable delivery of submission-ready documents.

Skills to highlight

  • Medical writing and editing
  • Regulatory submissions and CTD modules
  • Clinical study reports and investigator brochures
  • ICH/GCP and FDA/global regulatory requirements
  • Cross-functional collaboration with clinical development and regulatory affairs
  • Document planning and timeline management
  • Vendor and consultant oversight
  • Scientific accuracy and consistency in clinical documents

Role summary

A senior medical writing leadership role responsible for planning, authoring, reviewing, and finalizing clinical and regulatory documents for FDA and global submissions. The director manages internal and external writing resources, improves templates/processes, and ensures consistent scientific messaging across development programs.

We publish our own intelligence summary, never the full job description. Always confirm details with the employer when you apply.