Senior/Principal Regulatory Medical Writer and Manager of Regulatory Medical Writing
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Candidates MUST have at least some experience writing Clinical Trial Informed Consents, Clinical Trial Protocols and Safety Narratives. Education without practical working experience WILL NOT WORK.
Please inquire for formal job descriptions
Senior/Principal Regulatory Medical Writer (11 positions)
Manager Regulatory Medical Writing (1 position)
Home-Based in the US or Canada
Permanent (no option for contract)
- Will write clinical documents for submission to regulatory authorities
- Documents include briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document, clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy
- Will act in the capacity of project and/or lead for medical writing projects
- May serve as primary client contact and negotiate deliverable timelines and resolve project-related issues
- Will serve as the Medical Writing representative on cross-functional teams
- Will provide medical editing/review of draft and final documents prepared by other writers
- Will ensure document content/style adheres to FDA/EMA guidelines
- Will coordinate interdepartmental team review and sign-off of document deliverables
- Will coordinate production/distribution of draft/final documents
- Will perform literature searches/reviews for background information
- Will review statistical analysis plans/mock statistical output to assist in determining appropriateness of content/format for clinical writing
- Bachelor degree REQUIRED, advanced degree preferred
- Solid Regulatory/Clinical Medical Writing REQUIRED
- MUST include at least some experience writing Clinical Trial Informed Consents, Clinical Trial Protocols and Safety Narratives
- NDA Submission experience a PLUS
- Up to 15% domestic travel REQUIRED
Please email your resume to Lindsey Summers at lsummers(at)pharmascent(dot)com or call at 303-694-5482.
Pharmascent, A Division of The Ascent Services Group specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry.
Pharmascent specializes in contract staffing, contract to hire, direct hire search and small project consulting services for the FDA-regulated industries. Our team has over 40 years of combined experience in identifying top notch professionals for direct hire and contract staffing needs. We have an expansive network within the industry, enabling us to target and recruit qualified candidates in a timely and efficient manner. We understand that “people” are the key to a successful organization. Our goal is to deliver innovative people through proven best practices and effective resource optimization.
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