Senior Medical Writer (Remote - UK)
RemoteUnited Kingdom
United KingdomRemoteFull TimeSenior LevelPharmaceuticalMedium
Full TimeSenior LevelMediumPharmaceutical
Job Summary
Critically evaluate medical literature to select primary resources for study design, then write and edit clinical development documents including protocols, investigator's brochures, clinical study reports, and regulatory submissions. Manage timelines and workflows for writing assignments while interacting independently with clients to coordinate all project facets. Mentor junior medical writers and other team members involved in the writing process, ensuring adherence to client templates and style guides. Maintain ownership of assignments by proactively consulting department representatives for guidance.
Required Qualifications
- At least 3 years of previous experience in the pharmaceutical industry
- Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
- The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
- Substantial clinical study protocol experience, as lead author, required
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- Exceptional writing skills are a must
- Excellent organizational skills and the ability to multi-task are essential prerequisites
- Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
- Experience being a project lead, or managing a project team
Desired Qualifications
- Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
- Understanding of clinical data
- Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
- Not required, but experience with orphan drug designations and PSP/PIPs a plus
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