Senior Medical Writer – Oncology Focus (PhD Required)
Location:
home based
Type:
contract
Experience Level:
10+ Years
Industry:
Biotech / Pharma
Position Summary:
We are seeking a highly experienced Medical Writer with a strong oncology background and a PhD. This role is not for someone who’s only been in isolated writing roles — we're looking for someone who understands the entire document development lifecycle, has led major regulatory submissions, and can collaborate cross-functionally with internal teams and external vendors.
Must-Have Qualifications:
- PhD in life sciences or related field
- 10+ years of medical writing experience in the pharmaceutical or biotechnology industry
- Oncology experience is essential — candidates must have directly worked on oncology programs and be able to articulate this clearly in their CV
- Demonstrated leadership in writing and managing:
- INDs
- NDAs / BLAs
- Clinical Study Reports (CSRs)
- Investigator’s Brochures (IBs)
- Clinical Protocols
- Hands-on with TLFs – able to collate, interpret, and use them within deliverables
- Experienced in hosting and leading review meetings, commenting live, and managing follow-up discussions
- Ability to work across departments (regulatory, clinical, stats, vendors) to ensure deliverables are on time and high quality
- Clear, concise, scientifically accurate writing with strong attention to detail
Nice-to-Have Skills:
- Familiarity with Veeva Vault RIM
- Strong knowledge of AMA Manual of Style
- Experience using EndNote for reference management
- Comfort with document QC tools or review platforms
...