Medical Writer Ii, Oncology

Johnson & Johnson Johnson & Johnson · Pharma · Spring House, PA +8

This role focuses on medical writing within the pharmaceutical industry, specifically for oncology treatments. The Medical Writer II will develop, write, and coordinate various clinical and regulatory documents, including protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory responses. The position involves working within a team, adhering to established procedures and guidelines, and gaining knowledge of internal systems and regulatory requirements. The role requires interaction with cross-functional teams and may involve mentoring junior staff.

What you'd actually do

  1. Writes and coordinates basic clinical documents such as, but not limited to, Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs.
  2. Writes, contributes to, and/or coordinates low to medium complexity clinical and regulatory documents such as, but not limited to, Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision.
  3. Performs document QC, completes list of abbreviations or references, conducts literature searches, and performs other basic tasks with supervision as needed.
  4. Participates in and may lead cross-functional document planning and review meetings. Works in a team environment with some guidance while increasing independence for longer-term activities.
  5. Takes an active role on assigned projects with respect to timing, scheduling, and tracking.

Skills

Required

  • Medical writing experience
  • Knowledge of clinical and regulatory document types
  • Understanding of pharmaceutical industry processes
  • Ability to work in a team environment
  • Attention to detail

Nice to have

  • Experience with specific therapeutic areas (e.g., Oncology)
  • Familiarity with regulatory guidelines (e.g., ICH)
  • Mentoring or training experience