Medical Writer II, Clinical/Regulatory

Rezolute • Redwood City, CA

2d

About The Position

Rezolute is seeking an experienced, detail-oriented Medical Writer II to develop high-quality, scientifically accurate, and regulatory-compliant documents for clinical trials, regulatory submissions, and medical affairs. The role serves as medical writing lead on assigned projects and works with in-function and cross-functional teams on project strategies and writing activities. It coordinates document review and approval, obtains required documentation, manages competing demands and deliverables, identifies and resolves writing-related issues, and conducts team review meetings.

The Medical Writer II prepares clinical and regulatory documents, including protocols, investigator brochures, clinical study reports, patient narratives, and submissions such as INDs, NDAs, and CTDs. The role also develops academic manuscript drafts from limited source materials, reviews and edits team documents, manages multiple projects, conducts literature reviews, and interprets clinical, laboratory, and medical research data. The writer collaborates with clinical, regulatory, medical affairs, clients, and subject matter experts, and keeps current with regulatory guidance and industry trends. Documents must comply with applicable FDA, EMA, ICH, and other relevant requirements.

The anticipated base salary range is $110,000 to $135,000, depending in part on location and qualifications. The role is also eligible for an annual performance bonus under the applicable plan. Rezolute offers competitive compensation, stock options, and a benefits package.

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 or Project Server; and PowerPoint.
• Experience with 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 as part of a team while managing multiple priorities.
• 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 interest in applying them to regulatory and scientific writing.
• Ability to learn to use AI tools for drafting, summarizing, document comparison, and quality control while verifying generated content against source documents for accuracy, traceability, and compliance; prior AI medical-writing experience is not required.
• Experience writing across multiple therapeutic areas, including endocrinology, metabolism, 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 to 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 in nonclinical development, CMC, PK, PD, and antibody detection.

Responsibilities

• Prepare and author clinical trial protocols, investigator brochures, clinical study reports, patient narratives, regulatory submission documents, and academic manuscripts.
• Develop clear, concise, scientifically accurate documents for expert and non-expert audiences.
• Ensure documents comply with regulatory guidelines, industry standards, client specifications, and applicable FDA, EMA, and ICH requirements.
• Serve as medical writing lead on assigned projects and work with in-function and cross-functional teams on project strategies.
• Coordinate writing activities, document reviews and approvals, and other functions involved in producing writing projects.
• 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 and provide writing-related strategic advice.
• Review and edit cross-functional team documents for consistency, clarity, and scientific accuracy.
• Manage multiple writing projects, deadlines, and quality standards; identify and proactively address document-preparation challenges.
• Conduct literature reviews and interpret clinical trial, laboratory, and medical research data for clear and accurate presentation.
• Identify and propose solutions to writing-process issues and questions, resolving or escalating them as appropriate.
• Arrange and conduct team review meetings, obtain required documentation, and negotiate outcomes and deliverables across functional areas.
• Stay current with regulatory requirements, guidelines, and industry trends.

Benefits

• Competitive compensation
• Stock options
• Health insurance (medical, dental, and vision)
• Disability insurance
• Life insurance
• 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 the applicable plan and company and individual performance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level