Principal Medical Writer - CMC - US

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

As a Principal Medical Writer, your key responsibilities will include:

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.

Required Qualifications:

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). 

Key Competencies:

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. 

For further insight into who we are and what we do, please explore our website (www.trilogywriting.com).

Trilogy Writing & Consulting, an Indegene Company, is an Equal Opportunity Employer committed to fostering a culture of inclusion, diversity, and respect. We do not discriminate against any individual on the basis of race, color, religion or belief, sex, sexual orientation, gender identity or expression, age, national or ethnic origin, disability, marital or parental status, or any other characteristic protected under applicable laws. All employment decisions, including recruitment, hiring, training, compensation, promotion, and separation, are made based on business needs, individual merit, and qualifications. 

It is important to Trilogy to ensure the highest possible degree of protection for your personal data. All personal data collected and processed within the scope of an application for employment with Trilogy are protected against unauthorized access and manipulation by technical and organizational measures and are not forwarded to third parties. Your data will be collected for the purpose of filling employment opportunities offered by Trilogy Writing & Consulting GmbH in Germany or its subsidiaries Trilogy Writing & Consulting Ltd in the UK, Trilogy Writing & Consulting LLC in Canada, and Trilogy Writing & Consulting, Inc. in the USA. By submitting your data with this application, you consent to its use for this purpose within Trilogy. You can revoke this consent at any time without needing to give a reason by informing us of your revocation under [email protected]. In the event of revocation, we will delete your personal data immediately.