Medical Writer II, Clinical/Regulatory

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.