Associate Director, Clinical
ProKatchers LLC
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. Keywords: Regulatory Writer, Medical Writer, Clinical Regulatory Writer, Regulatory Affairs, IND, NDA, BLA, FDA, EMA, CSR, CSP, IB, Clinical Development, Drug Development, eCTD, Pharmaceutical, CRO, Submission Lead. #J-18808-Ljbffr ProKatchers LLC
Vacancy posted 1 day ago
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