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 addition to being responsible forleading 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:$150000 to $159000 USD; the salary range is an estimate and may vary based on experience level region and the Companys 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:510 years of experience in medical writing with a strong focus on CMC regulatory documentation.
• Education:Minimum of a Bachelors 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 ().

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 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 In the event of revocation we will delete your personal data immediately.

Required Experience:

Staff IC