Senior Director, Pharmaceutical and Medical Device Writing Services
Criterion Edge · United States · US
Medical Writing
Remote
physician
Pharmacist
Nurse
Demand68
Career growth62
Healthcare fit58
Remote potential95
5-year outlook
Senior director-level regulatory medical writing leadership typically commands high compensation, but exact pay varies by location, client mix, and business responsibilities; no salary figure is stated.
Clinical license
Not required
Applicant reach
narrow
Seniority
executive
Employment type
full-time
Date found
2026-10-18
Intelligence details
Flexible work details
- Engagement type
- Permanent
- Hours
- Full-time
- Eligible countries
- United States
- Profession fit
- physician, Pharmacist, Nurse
- 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 hands-on regulatory medical writing and submission leadership experience. Clinicians without a direct medical writing portfolio are unlikely to be competitive.
Who should apply
Senior regulatory medical writers with pharmaceutical/biologic submission experience and EU MDR CER expertise; clinicians who have spent years authoring INDs/NDAs/BLAs, CSRs, ISS/ISE, and leading writing teams or client engagements.
CV angle
Lead with documented authorship and leadership of INDs/NDAs/BLAs, CSRs, CTD Modules 2-5, ISS/ISE, CERs, Notified Body responses, cross-functional review resolution, and writer/client management. Use clinical training as supporting evidence of scientific judgment, not as a substitute for direct regulatory writing experience.
Skills to highlight
- Regulatory medical writing
- Clinical Study Reports (CSRs)
- CTD/eCTD Modules 2-5
- Clinical Evaluation Reports (CER)
- EU MDR
- Notified Body responses
- Cross-functional leadership
- Client relationship management
Role summary
A remote senior director role leading pharmaceutical and medical device regulatory writing services, including hands-on authorship and review of complex submissions, CERs under EU MDR, client advisory, writer development, resourcing, and quality oversight.
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