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Associate Director, Clinical

Job in Gaithersburg, Montgomery County, Maryland, 20883, USA
Listing for: ProKatchers LLC
Full Time position
Listed on 2026-08-18
Job specializations:
  • Pharmaceutical
    Medical Science Liaison
  • Healthcare
    Medical Science Liaison
Salary/Wage Range or Industry Benchmark: 120000 - 180000 USD Yearly USD 120000.00 180000.00 YEAR
Job Description & How to Apply Below

Job Title : Associate Director, Clinical/ Regulatory Writer

Location : Gaithersburg, MD 20878

Duration : 12 Months

Education : Master's Degree in a life science

Job Description :

We're seeking an experienced Regulatory Writer/Medical Writer with hands‑on pharmaceutical regulatory writing experience. The ideal candidate has authored Clinical Study Protocols (CSPs), Clinical Study Reports (CSRs), Investigator Brochures (IBs), Clinical Overviews, Clinical Summaries, Briefing Documents, and Health Authority responses throughout the drug development lifecycle.

Qualifications:

5–15 years of pharmaceutical regulatory writing experience.

Master's in Life Sciences (PhD preferred).

Experience leading regulatory document packages and cross‑functional teams.

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Position Requirements
10+ Years work experience
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