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! 😊

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