Senior​/Principal Medical Writer

Trilogy Writing & Consulting, a Indegene Company, is hiring Senior/Principal Medical Writers (USA) to produce regulatory documentation for the international pharmaceutical industry. You will play a pivotal role in delivering comprehensive services to our clients that extend beyond writing.

Applicants must live in the USA and be authorized to work for any employer in the USA. We are unable to sponsor visas. Candidates may work fully remotely or on a hybrid schedule from our Durham, NC office.

• Prepare a variety of clinical regulatory documents—including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications—as the lead writer in collaboration with client authoring teams.
• Ensure documents are produced according to agreed timelines, manage project budgets, adhere to SOPs, and meet the requirements of Trilogy and its clients.
• Provide document‑specific advice to clients.
• Oversee and coordinate other writers and QC specialists assisting with documents under your responsibility.
• Project‑manage timelines and review cycles of your documents.
• Work within the client’s regulatory document management systems.

• Minimum of a Bachelor’s degree in science or pharmacy (Ph.D. not required).
• Fluent written and spoken English skills.
• Minimum 3–5 years of experience actively writing regulatory documents; experience as a lead writer on CTD documents is required for Principal level.
• Experience as lead writer on key regulatory documents such as Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications.
• For Principal level: experience as lead writer with multiple‑document projects involving global, multinational teams, including team management, project management, review management, and budget oversight.
• Ability to manage multiple projects simultaneously.
• Experience interacting directly with clients or authors, coordinating review cycles, meetings, and project timelines.
• In‑depth knowledge of regulatory guidance (e.g., ICH, FDA, EMA) for clinical trial conduct and document‑specific guidance.
• For Principal level: experience in multiple therapeutic areas, allowing confident work without lead‑in time.
• Competency in using document management systems and review tools.
• A keen eye for detail and appreciation for well‑written documents.
• Excellent interpersonal skills and ability to collaborate with diverse team members.
• Flexibility and focus under tight timelines.

• Competitive base salary range: $120,000 to $159,000 USD (approximate; actual compensation varies by experience and location).
• Annual bonus opportunity.
• Generous paid time off (vacation, holiday, birthday, illness).
• Comprehensive benefits: medical, dental, vision, disability, life insurance (AD&D).
• 401(k) retirement savings plan with company match.
• Full AMWA membership and annual conference attendance paid.
• Continuous personal and professional development opportunities.
• Free weekly yoga sessions.
• Other fun and exciting events that encourage team bonding and development.

Trilogy Writing & Consulting, an Indegene Company, is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate merit, and qualification.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.