Regulatory Medical Writer
Salary: £36,000 – £49,000 plus benefits.
Location: Stratford, London (1–2 days a week in the office); home‑based contracts available. Occasional travel within London area (4–6 times a year); travel expenses not covered.
Contract: 24 months fixed term.
Hours: 35 hours per week (flexible work requests considered, minimum 32 hours).
Closing date: 3rd June 23:55pm.
Visa: Must be eligible to work in the UK; no sponsorship offered.
Role Overview
Support the CRUK Centre for Drug Development platform trial DETERMINE by providing regulatory medical writing expertise for early phase oncology trials.
Responsibilities
- Write, edit, review, and quality‑control clinical study reports and investigator brochures.
- Manage the preparation of clinical study reports, building consensus on requirements, responsibilities, and timelines with project teams.
- Participate in preparation and review of summary clinical trial results and other disclosures.
- Schedule, prepare, and update investigator brochure packages in CDD‑sponsored trials, ensuring annual review in line with regulations.
- Liaise with the project team to complete project‑specific tasks including review of protocols, Trial Master Files, data (including expert reports), and analytical plans.
Qualifications & Experience
- Proven experience in medical / medical sciences writing.
- Significant experience in regulatory medical writing or a mix of regulatory writing plus substantial related experience in clinical trials, pharmacovigilance or medical writing.
- Science graduate or equivalent scientific writing experience.
- Good knowledge of regulatory requirements for clinical trial documents (investigator brochures, clinical study reports, posting of trial summary results).
- Excellent proofreading skills and attention to detail.
- Confident communication skills, able to foster strong internal and external working relationships.
- Project‑management skills.
- Experience in early phase oncology trials desirable but not essential.
Benefits
Generous benefits package; wide range of career and personal development opportunities; high‑quality tools; policies and processes to support work‑life balance and personal wellbeing.
Diversity & Inclusion
We actively encourage applications from people of all backgrounds and cultures, particularly those from ethnic minority backgrounds who are currently under‑represented. We aim to support every candidate to perform at their best throughout the application and work experience.
Recruitment Policy
Applicants under 18 will not be recruited.
#J-18808-Ljbffr…