Principal Medical Writer - CMC - US
About The Position
Trilogy Writing & Consulting, an Indegene Company, has an immediate opening for a Principal Medical Writer specializing in Chemistry, Manufacturing, and Controls (CMC) in the United States (East Coast). At Trilogy, you will support our growing company in producing regulatory documentation for the international pharmaceutical industry and will play a pivotal role in delivering comprehensive services to our clients that extend beyond writing. We are seeking a CMC writer experienced in interpreting technical data from manufacturing, quality control, and analytical development teams to create comprehensive, compliant, and accurate CMC dossiers for regulatory authorities. In addition to being responsible for leading the development, review, and finalization of high-quality documentation for regulatory submissions (e.g., IND, NDA, BLA, MAA), you will serve as a subject matter expert supporting the development of our medical writing AI platform. Applicants must live in the US and be authorized to work for any employer in the US (we are unable to sponsor or take over sponsorship of an employment visa at this time); may work either fully remotely or a hybrid schedule (in office/remote) from our Durham, NC, USA office. Trilogy offers the following: Competitive base salary (range: $150,000 to $159,000 USD; the salary range is an estimate and may vary based on experience level, region, and the Company’s compensation practices) Annual bonus opportunity A generous allowance of paid time off (vacation, holiday, birthday, illness) Comprehensive benefit plans to include medical, dental, vision, disability, life insurance with AD&D 401K retirement savings plan with company match Full AMWA membership and annual conference attendance paid for by Trilogy Continuous personal and professional development opportunities Free weekly yoga sessions Other fun and exciting events that encourage team bonding and development
Requirements
- Industry Experience: 5–10+ years of experience in medical writing, with a strong focus on CMC regulatory documentation.
- Education: Minimum of a Bachelor’s degree in Chemistry, Pharmacy, or a relevant scientific discipline.
- Regulatory Knowledge: Deep understanding of ICH Guidelines, particularly for Module 3 (CMC).
- Communication: Excellent written and oral communication skills, with the ability to explain complex scientific concepts to diverse audiences.
- Project Management: Strong ability to manage multiple, complex projects with shifting priorities.
- Software Proficiency: Expert knowledge of Microsoft Office Suite (Word, Excel) and Electronic Document Management Systems (eDMS).
Nice To Haves
- Strategic Thinking: Ability to anticipate, identify, and resolve issues, ensuring smooth regulatory submission processes.
- Attention to Detail: Exceptional capability for identifying errors in scientific data, spelling, grammar, and formatting.
- Collaboration: Proven ability to work in a collaborative, cross-functional team environment.
Responsibilities
- Document Development: Write, edit, and review complex CMC regulatory documents, including Module 3 (Quality) of the eCTD, Quality Overall Summaries (QOS), and briefing books.
- Data Synthesis: Interpret and summarize technical data from analytical development, drug substance, and drug product manufacturing, ensuring consistency with regulatory standards.
- Regulatory Compliance & Strategy: Ensure all documents adhere to ICH, FDA, and EMA regulations. Collaborate with Regulatory Affairs to develop submission strategies.
- Supporting AI development: Drive development of the CMC outputs by generating and reviewing CMC outputs from our medical writing platform and working with the AI development team to improve the quality of the outputs
- Cross-functional Leadership: Lead CMC writing teams, coordinating inputs from diverse departments such as Manufacturing, Quality Assurance, Regulatory Affairs, and CMC technical teams.
- Quality Control & Review: Perform rigorous peer reviews and final quality checks on documents to ensure scientific accuracy, clarity, and grammatical correctness.
- Mentorship: Provide guidance, training, and mentorship to junior medical writers.
Benefits
- Competitive base salary (range: $150,000 to $159,000 USD; the salary range is an estimate and may vary based on experience level, region, and the Company’s compensation practices)
- Annual bonus opportunity
- A generous allowance of paid time off (vacation, holiday, birthday, illness)
- Comprehensive benefit plans to include medical, dental, vision, disability, life insurance with AD&D
- 401K retirement savings plan with company match
- Full AMWA membership and annual conference attendance paid for by Trilogy
- Continuous personal and professional development opportunities
- Free weekly yoga sessions
- Other fun and exciting events that encourage team bonding and development
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
