Remote Medical Writer (part time) – Oncology (PhD Required)

Remote Medical Writer (part time) – Oncology (PhD Required)

Contract Type:

Contractor

Location:

New Jersey

Industry:

Pharmaceuticals

Contact Name:

Divna Rosenzweig

Contact Phone:

Date Published:

01-Jul-2025

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



...

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