Freelance Medical Writer

Location: United States (Bay Area strongly preferred)Therapeutic Focus: Immune Tolerance | Regulatory T Cells | Autoimmune Diseases | EpigeneticsEmployment Type: ContractAbout RegCellRegCell 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 / RemoteRegCell 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 updatesInformed consent forms and patient-facing materialsStudy-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 documentationStrong command of ICH E6, E8, E3 guidelines and FDA regulatory documentation requirementsAdvanced degree in life sciences, pharmacy, or related discipline (PhD, PharmD, or MS preferred)Ability to work independently, manage multiple deliverables, and thrive on compressed timelinesExperience with cell therapy, gene therapy, or autoimmune/immunology programs is a strong plusPrior experience supporting first-in-human studies at early-stage biotech is highly valuedHow to ApplyApply directly through LinkedIn. Please attach the following to your application:Your CV or resume1–2 writing samples — published documents or appropriately redacted regulatory writing (e.g., protocol, IB section, CSR narrative, or FDA briefing document)