Principal Medical Writer
On-siteLondon, England, United Kingdom
Job Summary
Author high-quality medical writing deliverables for a top 5 pharmaceutical client, including protocols, study reports, IBs, ICFs, and complex regulatory documents like IND, NDA, and BLA submissions. Manage clinical program documents, coordinate cross-functional resources, and lead team meetings while independently authoring clinical, safety, and regulatory content across all research phases. Supervise less experienced writers, perform peer reviews, and conduct QC checks on documents and statistical outputs. Communicate directly with clients and internal leadership to manage timelines, expectations, and budgeted hours. Support project-related administrative tasks and maintain familiarity with ICH guidelines, EU MDR/IVDR, and company SOPs. Based in the UK or Ireland, this role requires 7+ years of experience in clinical and regulatory writing for pharma or biotech organizations.
Required Qualifications
- Advanced knowledge of clinical research principles
- demonstrated ability to interpret and present clinical data and other complex information
- Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines
- Advanced understanding of regulatory submission requirements and processes
- Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures
- Exceptional project management skills
- strong communication skills
- high attention to detail and quality
- English language proficiency
- familiarity with American Medical Association (AMA) style
- Strong experience in relationship building and strategic collaboration on key business accounts
- Thinks proactively, takes initiative, and willingly takes on new challenges
- Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables
- Works independently with exceptional time-management skills
- Works effectively in a collaborative team environment
- Demonstrates a growth mindset and positive outlook in all work activities
- Bachelor's degree or higher, preferably in medical or scientific discipline
- Minimum of 7 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company
Desired Qualifications
- proven early phase experience
- support a 'top 5' Pharmaceutical client
- Based in the UK or Ireland
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