We're Hiring – Medical Writer Consultant (Contract)
📍 Location: US Remote (West Coast preferred)
📅 Contract: Initial 3–6 months, potential extension
⏰ Workload: 20–40 hours per week
🚀 Start: November 2026
I'm currently supporting a pharmaceutical organisation looking for an experienced Medical Writer Consultant to join on a freelance basis.
This opportunity will focus on hands-on medical writing across late-stage clinical development and upcoming FDA regulatory submission activities.
Key Responsibilities:
- Draft, review and finalise clinical and regulatory submission documents, including NDA/BLA documentation.
- Prepare CTD clinical modules, clinical summaries, integrated summaries and clinical study reports (CSRs).
- Support FDA response packages, briefing books and agency meeting materials.
- Collaborate with Regulatory Affairs, Clinical Development, Biostatistics and Medical teams.
- Independently manage medical writing deliverables from first draft through finalisation.
Key Requirements:
- Ideally 7+ years of medical writing experience within pharmaceutical or biotechnology organisations.
- Direct NDA and/or BLA submission experience is essential.
- Strong experience writing FDA-facing regulatory documents.
- Experience supporting late-stage / Phase III clinical development programmes.
- Ability to work independently and manage competing submission deadlines.
- NDA/BLA resubmission or Complete Response Letter (CRL) experience is highly desirable.
- Experience in a small biotech or lean pharmaceutical environment is advantageous.
If this sounds relevant to your background, please reach out or apply directly. I'd love to share more details! 😊
