Principal Medical Writer (Remote - UK)
RemoteUnited Kingdom
United KingdomRemoteFull TimeSenior LevelDoctorate Or Professional DegreePharmaceuticalMedium
Full TimeSenior LevelDoctorate Or Professional DegreeMediumPharmaceutical
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 Module documents. Maintain timelines and workflow for writing assignments while interacting independently with clients to coordinate project facets. Mentor medical writers and other team members involved in the writing process, taking ownership of assignments by proactively consulting department representatives for guidance. Manage production of interpretive guides with a focus on scientific rigor and absence of bias.
Required Qualifications
- Bachelor's, Masters or PhD Degree in scientific, medical, clinical discipline or related field
- at least 6 years of previous regulatory writing experience
- Substantial clinical study protocol experience, as lead author
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- Understanding of clinical data
- Exceptional writing skills
- Excellent organizational skills and the ability to multi-task
- Expert proficiency with styles of writing for various regulatory documents
- Expert proficiency with client templates & style guides
- competent communicator skills for projects
- Take ownership of a given assignment
- proactively consulting other project team members and other department representatives for information or guidance as necessary
- Mentor medical writers and other members of the project team who are involved in the writing process
- 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
- Must be available for weekend shifts
- Must be able to lift 50 lbs
Desired Qualifications
- Masters or Phd degree
- Experience in regulatory submissions (clinical study reports) presented to regulatory authorities
- Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines
- Not required, but experience with orphan drug designations and PSP/PIPs
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