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Principal Regulatory Medical Writer
Cancer Research UK (CRUK). Provide expert medical writing support across regulatory and scientific documents, including Clinical Study Reports, Investigator’s Brochures, and other clinical and scientific reports .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing for regulatory documents, including Clinical Study Reports and Investigator’s Brochures, while ensuring compliance with regulatory standards. Capable of mentoring junior staff and managing cross-functional collaborations to enhance document quality and consistency.
Highest-signal resume keywords
Regulatory Writing ExperienceClinical Study Reports (CSRs)Investigator’s Brochures (IBs)Proofreading SkillsProject Management Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical WritingQuality ControlDocument PreparationClinical Trial DocumentationCompliance Metrics CompilationSOP DevelopmentScientific Report WritingEditingReviewingAttention to Detail
Soft Skills
Organisational SkillsCommunication SkillsNegotiation SkillsInfluencing Skills
Certifications & Qualifications
Higher Degree (Masters or PhD)
Industry Keywords
Medical WritingBiomedical SciencesPharmaceuticalClinical DevelopmentOncologyEarly Phase Clinical DevelopmentDevelopment Safety Update Reports (DSURs)
About the role
Key responsibilities & impact- Provide expert medical writing support across regulatory and scientific documents, including Clinical Study Reports, Investigator’s Brochures, and other clinical and scientific reports
- Act as a subject matter expert in Medical Writing activities
- Train medical writers and mentor new starters and junior Medical Writing staff
- Deputise for the Medical Writing Manager on delegated tasks
- Represent the Medical Writing group on cross-functional working groups
- Write, edit, review, and quality-control medical writing deliverables
- Ensure timely production of CSRs and IBs within applicable regulatory timeframes
- Manage preparation, updating, and tracking of CSRs, clinical trial summary results, and IB packages
- Compile compliance metrics
- Improve document writing processes and promote consistency and best practice
- Produce and maintain regulatory document templates, SOPs, and guidance documents
- Maintain awareness of CDD clinical trials and key projects
- Build relationships with CDD functions to support timely delivery of data and documents
- Review third-party documents to assess the need for IB supplements
- Assist with recruitment and potentially line-manage up to two Medical Writing team members
Requirements
What you’ll need- Science graduate (Medical/Biomedical Sciences/Pharmaceutical/Pharmacy)
- Extensive regulatory writing experience with clinical trial documents, including CSRs and IBs
- Ideally, experience working with Protocols and Development Safety Update Reports (DSURs)
- Ability to produce high-quality, scientifically and medically accurate reports
- Experience reviewing and quality checking other Medical Writers’ work
- Excellent proofreading skills and attention to detail
- Organisational and communication skills
- Negotiation and influencing skills
- Excellent written and spoken English
- Medical/Medical Sciences background or experience desirable
- Higher degree (Masters or PhD) desirable
- Experience in early phase clinical development desirable
- Oncology experience desirable
- Project management experience desirable
- Must be aged 18 or over
Benefits
Comp & perks- Benefits package
- Career and personal development opportunities
- High-quality tools
- Flexible working policy and flexible working requests considered
- Home-based contract option
- Work-life balance support
- Wellbeing support
- Adjustments during the application, interview, and work process where needed