Medical Writer II, Clinical/Regulatory
About The Position
Rezolute is seeking an experienced, detail-oriented Medical Writer II to develop high-quality, scientifically accurate, regulatory-compliant documents supporting clinical trials, regulatory submissions, and medical affairs. The position serves as medical writing lead on assigned projects and works with in-function and cross-functional teams on project strategies and deliverables. The Medical Writer coordinates project preparation, review, and approval; works with functional areas to address competing demands; resolves or escalates issues; conducts review meetings; and ensures required documentation is obtained. The role collaborates with clinical researchers, regulatory professionals, medical affairs teams, clients, and subject matter experts. It includes authoring clinical and regulatory documents, independently drafting academic manuscripts from limited source materials, reviewing and editing scientific content, managing multiple writing projects, conducting literature reviews, interpreting research and clinical trial data, and maintaining current knowledge of regulatory requirements and industry trends. Documents must comply with applicable FDA, EMA, ICH, and other relevant requirements.
Requirements
- Bachelor's degree or higher.
- 1–2 years of experience as a medical writer, focused on clinical, regulatory, or scientific writing in the pharmaceutical, biotechnology, or healthcare industries.
- Demonstrated experience preparing regulatory documents and publications for submission to regulatory agencies such as the FDA or EMA.
- Strong understanding of clinical trial methodology and regulatory requirements.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Word, including templates; Microsoft Copilot; Excel; Adobe Acrobat; MS Project/Project Server; and PowerPoint.
- Experience using document management software such as SharePoint or Veeva.
- High attention to detail and ability to critically evaluate and edit scientific content.
- Ability to work independently and collaboratively while managing multiple priorities effectively.
- Proficiency with medical writing tools, reference management software, and Microsoft Office Suite.
Nice To Haves
- Master's or PhD in life sciences, pharmacology, medicine, or a related field.
- Regular personal or professional use of generative AI tools such as ChatGPT, Claude, Copilot, or Perplexity, and eagerness to apply them to regulatory and scientific writing. Prior medical-writing AI experience is not required; candidates should be able to learn to use the tools for drafting, summarizing, comparing documents, and quality control while verifying generated content against source documents for accuracy, traceability, and compliance.
- Experience writing across multiple therapeutic areas, including endocrinology, metabolism, and/or rare diseases.
- Knowledge of medical writing software such as EndNote, Adobe Acrobat, and other document management tools.
- Advanced understanding of drug development from discovery through market, biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and dataset generation.
- Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.
Responsibilities
- Prepare and author clinical trial protocols, investigator brochures, clinical study reports, patient narratives, and regulatory submission documents such as INDs, NDAs, and CTDs.
- Independently prepare complete, high-quality first drafts of academic manuscripts from a limited set of source materials, with minimal supervision.
- Develop clear, concise, scientifically accurate documents for expert and non-expert audiences.
- Ensure documents comply with regulatory guidelines, industry standards, and client specifications.
- Work with clinical, regulatory, and medical affairs teams to deliver high-quality documents on time.
- Liaise with clients to understand project requirements and meet expectations.
- Lead or contribute to client meetings and presentations, providing strategic advice on writing-related matters.
- Review and edit documents prepared by cross-functional team members for consistency, clarity, and scientific accuracy.
- Manage multiple writing projects and meet deadlines and quality standards.
- Identify and proactively address challenges in document preparation.
- Conduct literature reviews and interpret clinical trial, laboratory, and medical research data.
- Stay up to date on regulatory requirements, guidelines, and industry trends, and ensure documents comply with applicable FDA, EMA, ICH, and other requirements.
- Lead assigned writing projects, coordinate preparation, review, approval, and related functions, negotiate deliverables across functional areas, address or escalate issues, conduct review meetings, and ensure required documentation is obtained.
Benefits
- Competitive compensation
- Stock options
- Health insurance (medical, dental, and vision)
- Disability, life, and long-term care insurance
- Holiday pay
- Tracking Free Vacation Program
- 401(k) plan match
- Educational assistance benefit
- Fitness center reimbursement
- Annual performance bonus, subject to applicable plan terms and company and individual performance
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
