---
title: 'Medical Writer II, Clinical/Regulatory at Rezolute'
canonical: 'https://feeny.ai/job/medical-writer-ii-clinical-regulatory-rezolute-redwood-city-h43j74mshd1b'
type: 'job'
last_seen: '2026-10-16'
---

# Medical Writer II, Clinical/Regulatory at Rezolute

- **Company:** Rezolute
- **Location:** Redwood City, CA
- **Work type:** onsite
- **Posted:** 2026-10-15
- **Last confirmed live:** 2026-10-16
- **Apply:** https://jobs.lever.co/rezolutebio/07b0ffb2-4a20-4d40-a94c-44ce2bf118e0

## Job description

Location: Redwood City, California

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).

We are seeking an experienced and detail-oriented Medical Writer II to join our dynamic team. In this role, you will be responsible for developing high-quality, scientifically accurate, and regulatory-compliant documents for clinical trials, regulatory submissions and medical affairs. Interfaces with cross-functional groups to ensure accurate and timely completion/delivery of information and review of writing projects. You will collaborate with cross-functional teams, including clinical researchers, regulatory professionals, and subject matter experts, to produce materials that support the advancement of clinical trials, product development, and regulatory submissions.

The Medical Writer II serves as medical writing lead on assigned projects. Works closely with in-function and cross-functional team(s) on project strategies. Implements all activities related to the preparation of writing projects. Coordinates the review, approval, and other appropriate functions involved in the production of writing projects. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.  Arranges and conducts review meetings with the team. Ensures required documentation is obtained.

## Responsibilities

- Scientific Writing & Documentation:
- Prepare and author clinical trial protocols, investigator brochures, clinical study reports, patient narratives, and regulatory submission documents (e.g., INDs, NDAs, CTDs).
- Able to take a limited set of source materials and independently write complete, high-quality first draft of academic manuscripts with minimal supervision.
- Develop clear, concise, and scientifically accurate documents that communicate complex medical and scientific information to both expert and non-expert audiences.
- Ensure compliance with regulatory guidelines, industry standards, and client specifications.
- Collaboration & Communication:
- Work closely with clinical, regulatory, and medical affairs teams to ensure the timely delivery of high-quality documents.
- Liaise with clients to understand project requirements and ensure that their expectations are met.
- Lead or contribute to client meetings and presentations, providing strategic advice on writing-related matters.
- Review & Editing:
- Review and edit documents prepared by cross-functional team members, ensuring consistency, clarity, and scientific accuracy.
- Project Management:
- Manage multiple writing projects simultaneously, ensuring deadlines and quality standards are met.
- Identify potential challenges in document preparation and proactively address them.
- Research & Analysis:
- Conduct in-depth literature reviews to gather relevant background information.
- Interpret complex data from clinical trials, laboratory studies, and medical research to present findings clearly and accurately.
- Regulatory Knowledge:
- Stay up-to-date with changes in regulatory requirements, guidelines, and industry trends.
- Ensure that all documents comply with the latest FDA, EMA, ICH, and other relevant regulatory requirements.

Qualifications:

- BA or higher degree. A Master’s or PhD in life sciences, pharmacology, medicine, or a related field is preferred.
- 1-2 years of experience as a medical writer, with a focus on clinical, regulatory, or scientific writing in the pharmaceutical, biotechnology, or healthcare industries.
- Demonstrated experience in preparing regulatory documents and publications for submission to regulatory agencies (e.g., FDA, EMA).

Skills & Competencies:

- Strong understanding of clinical trial methodology and regulatory requirements.
- Excellent written and verbal communication skills.
- Proficient in Microsoft Word (including the use of templates), Microsoft Copilot, Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint.
- Experience using document management software (e.g. SharePoint, Veeva)
- High attention to detail, with the ability to critically evaluate and edit scientific content.
- Ability to work independently and as part of a team, managing multiple priorities effectively.
- Proficiency with medical writing tools, reference management software, and Microsoft Office Suite.
- Preferred:
- Very comfortable with generative AI tools (e.g., ChatGPT, Claude, Copilot, Perplexity) through regular personal or professional use, and eager to apply them to regulatory and scientific writing. Prior experience using AI for medical writing is not required, but candidates should be able to learn quickly how to use these tools in drafting, summarizing, comparing documents and quality control, while checking all AI-generated content against source documents to maintain accuracy, traceability and compliance.
- Experience in writing for multiple therapeutic areas, including endocrinology, metabolism, and/or rare diseases.
- Knowledge of medical writing software (e.g., EndNote, Adobe Acrobat, and other document management tools).
- Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets. Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.

Rezolute (RZLT) currently anticipates the base salary for the Medical Writer II role could range from $110,000 to $135,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate. Rezolute offers competitive compensation, stock options and a rich benefits package.

Qualifying employees are eligible to participate in benefit programs such as:

- Health Insurance (Medical / Dental / Vision)
- Disability, Life & Long-Term Care Insurance
- Holiday Pay
- Tracking Free Vacation Program
- 401(k) Plan Match
- Educational Assistance Benefit
- Fitness Center Reimbursement

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.

## About Rezolute

## Company Overview
- **One-liner**: Rezolute is a late-stage rare disease biotechnology company developing ersodetug, a monoclonal antibody therapy for hypoglycemia caused by congenital and tumor hyperinsulinism.
- **Entity Type**: Public (Nasdaq: RZLT)
- **Headquarters**: Redwood City, California, United States (with an additional office in Louisville)
- **Founded**: Not publicly available (IPO 2012)
- **Founders**: Not publicly available

## Core Business
- **Primary industry**: Biotechnology – rare disease therapeutics
- **Target customers**: B2B – healthcare providers, patients, and payers; focuses on addressing severe unmet medical needs in hyperinsulinism
- **Mission/purpose**: Significantly improve outcomes for individuals with hypoglycemia caused by hyperinsulinism ([rezolutebio.com – About](https://rezolutebio.com/job-openings/))

## Products & Services
- **Ersodetug (lead candidate)**: An intravenously administered human monoclonal antibody that allosterically binds to the insulin receptor, down‑modulating insulin action to restore normal glucose levels. Being developed for two indications:
  - **Congenital Hyperinsulinism (sunRIZE Phase 3 study)** – completed enrollment (May 2025) with 62 participants; topline results expected December 2025.
  - **Tumor Hyperinsulinism (upLIFT Phase 3 study)** – initiated mid‑2025; FDA agreed to a single‑arm open‑label design; topline results expected second half 2026.
  - Designations: Orphan Drug (US/EU), Rare Pediatric Disease, Breakthrough Therapy (US), PRIME (EU), ILAP (UK) ([ir.rezolutebio.com – 10-K](https://ir.rezolutebio.com/sec-filings/content/0001104659-25-090848/0001104659-25-090848.pdf))

## Market Standing
- **Valuation/Market Cap**: $317.7 million (as of recent data, per LinkedIn) ([linkedin.com](https://linkedin.com/company/rezolute))
- **Key Metric (Public)**: Annual revenue of $14.1 million (likely from grants or collaboration revenue; no product revenue yet) ([linkedin.com](https://linkedin.com/company/rezolute))
- **Notable Investors/Partners**: Not publicly available – company is publicly traded and does not disclose a lead investor list. Key partners include clinical trial sites and regulatory agencies (FDA, EMA).
- **Growth Signals**:
  - Headcount: 50 employees (+2.9% YoY) ([linkedin.com](https://linkedin.com/company/rezolute))
  - Phase 3 sunRIZE study fully enrolled; topline data pending December 2025.
  - Phase 3 upLIFT study enrolling with streamlined design; data expected second half 2026.
  - FDA granted Breakthrough Therapy Designation for tumor HI in May 2025.
  - Multiple regulatory designations accelerating development pathway.

## Competitive Advantages
- **Unique mechanism**: Ersodetug acts downstream from beta cells at the insulin receptor, allowing it to potentially treat all forms of hyperinsulinism (genetic or acquired) regardless of underlying cause.
- **Dosing convenience**: Half‑life >2 weeks enables monthly intravenous administration.
- **Regulatory momentum**: Orphan Drug, Rare Pediatric Disease, Breakthrough Therapy, PRIME, and ILAP designations provide expedited review, potential priority review voucher, and closer FDA/EMA collaboration.
- **Pivotal data catalysts**: Two Phase 3 studies read out within ~12‑18 months, creating clear value inflection points.

## Strategic Focus
- Execute the two ongoing Phase 3 trials (sunRIZE in congenital HI, upLIFT in tumor HI).
- Assuming positive topline data from sunRIZE, submit a Biologics License Application (BLA) to the FDA for ersodetug in mid‑2026.
- Continue to build commercial and medical affairs infrastructure (recent job postings indicate hires in Commercial Operations, Marketing, Payer Strategy, and Supply Chain) ([rezolutebio.com – Job Openings](https://rezolutebio.com/job-openings/)).

## Why Work Here
- **Mission‑driven**: Employees work on therapies for ultra‑rare, life‑threatening conditions with high unmet medical need.
- **Benefits**: Comprehensive health/dental/vision insurance, competitive salaries, annual bonus, 401(k) with company match, tuition assistance, on‑site meals, flexible spending accounts ([rezolutebio.com – Benefits](https://rezolutebio.com/job-openings/)).
- **Work environment**: Hybrid/office policy not explicitly stated; roles are based in Redwood City (HQ) and Louisville. Recent openings include remote-friendly functions? Not confirmed.
- **Growth opportunity**: Small company (~50 people) entering late‑stage development and pre‑commercial build‑out – employees can have broad impact and career advancement.
- **Engineering culture**: For biotech, the focus is on clinical operations, regulatory, and commercial roles rather than traditional engineering. IT positions (Business System Engineer) exist.

## Sources
1. [linkedin.com – Rezolute company page](https://linkedin.com/company/rezolute)
2. [rezolutebio.com – Job Openings & Benefits](https://rezolutebio.com/job-openings/)
3. [ir.rezolutebio.com – SEC 10-K Filing (September 2025)](https://ir.rezolutebio.com/sec-filings/content/0001104659-25-090848/0001104659-25-090848.pdf)
4. [rezolutebio.com – Leadership page](https://rezolutebio.com/leadership/)

## Other roles at Rezolute

- [Executive & Administrative Business Partner](https://feeny.ai/job/executive-administrative-business-partner-rezolute-redwood-city-c1620sbmm02k) — Redwood City, CA
- [Director / Senior Director, Pharmacovigilance Operations](https://feeny.ai/job/director-senior-director-pharmacovigilance-operations-rezolute-remote-dnq13sn8dzh0)
- [Manager, Statistical Programming](https://feeny.ai/job/manager-statistical-programming-rezolute-remote-g58ra51zr042)
- [Manager, Quality Assurance](https://feeny.ai/job/manager-quality-assurance-rezolute-redwood-city-ea9hyav4h4dr) — Redwood City, CA
- [Sr. Medical Science Liaison](https://feeny.ai/job/sr-medical-science-liaison-rezolute-remote-p0q0xz8s2neg)
- [Senior Manager, External Supplier Operations](https://feeny.ai/job/senior-manager-external-supplier-operations-rezolute-redwood-city-pqxs0q5vsnyp) — Redwood City, CA
- [Sr Director, Regulatory Affairs](https://feeny.ai/job/sr-director-regulatory-affairs-rezolute-redwood-city-wqvf8n5fvptf) — Redwood City, CA
- [Head of Global Product Supply](https://feeny.ai/job/head-of-global-product-supply-rezolute-redwood-city-9yv4d2b9fg0s) — Redwood City, CA
- [Director Program Manager, Product Launch (Rare Disease)](https://feeny.ai/job/director-program-manager-product-launch-rare-disease-rezolute-redwood-city-vn56yjrm5v16) — Redwood City, CA
- [Sr. Director, Commercial Supply Chain](https://feeny.ai/job/sr-director-commercial-supply-chain-rezolute-redwood-city-e3ss6gz4cayw) — Redwood City, CA