Location: United States (Bay Area strongly preferred)

Therapeutic Focus: Immune Tolerance | Regulatory T Cells | Autoimmune Diseases | Epigenetics

Employment Type: Contract

About RegCell

RegCell is a biotechnology company developing an epigenetic reprogramming approach to restore antigen-specific immune tolerance by generating highly functional, stable regulatory T cells.

Cofounded by 2025 Nobel Laureate Professor Shimon Sakaguchi, whose discovery of regulatory T cells fundamentally transformed the understanding of immune tolerance and autoimmunity, RegCell is advancing a next-generation therapeutic strategy with the potential to meaningfully improve treatment approaches for autoimmune and immune-mediated diseases.

Medical Writer, Clinical Development (Consultant) | RegCell | San Francisco Bay Area / Remote

RegCell is a clinical-stage biotech pioneering epigenetic Treg cell therapy for autoimmune disease. We are engineering regulatory T cells to restore immune tolerance, a fundamentally new approach to treating conditions where the immune system attacks the body. We're advancing our lead program toward first-in-human studies.

We're looking for an experienced Medical Writer to join us on a consulting basis and help prepare the clinical development documents that will underpin our IND submission and first-in-human study.

What you'll work on:

Investigator's Brochure (IB) — authorship and updates
Informed consent forms and patient-facing materials
Study-level operational documents (monitoring plans, pharmacy manuals, study reference materials)
From time to time, you may be asked to prepare or revise agency, query responses, CSRs, and related documents.

What we're looking for:

5+ years of clinical medical writing experience in biotech or pharma, including sponsor-side IND and Phase I documentation
Strong command of ICH E6, E8, E3 guidelines and FDA regulatory documentation requirements
Advanced degree in life sciences, pharmacy, or related discipline (PhD, PharmD, or MS preferred)
Ability to work independently, manage multiple deliverables, and thrive on compressed timelines
Experience with cell therapy, gene therapy, or autoimmune/immunology programs is a strong plus
Prior experience supporting first-in-human studies at early-stage biotech is highly valued

How to Apply

Apply directly through LinkedIn. Please attach the following to your application:

Your CV or resume
1–2 writing samples — published documents or appropriately redacted regulatory writing (e.g., protocol, IB section, CSR narrative, or FDA briefing document)

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