Based on the discovery by our Founder, Professor Shimon Sakaguchi, we are developing stable, functional-induced Tregs that are antigen-specific (S/F-iTregs). Our S/F-iTregs address the limitations of earlier attempts to create therapeutic Tregs and competitive advantages over CAR-Treg approaches.

Industry: Biotechnology Research
Company Size: 2-10 employees

RegCell

Savvy Admin PROD

**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)

Freelance Medical Writer

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