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)
