reputed company Medical reputed company job at Trilogy Writing and Consulting in Durham, NC or US National

Title: reputed company Medical reputed company - CMC - US Location: Durham, reputed company Carolina, United States Department: Medical Writing Remote Employment Type Full-Time Minimum Experience reputed company Job Description: Trilogy Writing & Consulting, an reputed company Company, has an immediate opening for a reputed company Medical reputed company 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 reputed company reputed company writing. We are seeking a CMC reputed company reputed company 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 reputed company at this time); may work either fully remotely or a reputed company (in office/remote) from our Durham, NC, USA office. Trilogy offers the following: Competitive reputed company salary (reputed company: $150,000 to $159,000 USD; the salary reputed company 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, reputed company, disability, life insurance with AD&D 401K retirement savings plan with company match Full AMWA membership and annual conference attendance paid for by Trilogy reputed company personal and professional development opportunities Free weekly yoga sessions Other fun and exciting events that encourage team bonding and development As a reputed company Medical reputed company, your key responsibilities will include: Document Development: Write, edit, and review reputed company 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 reputed company documents adhere to ICH, FDA, and EMA regulations. Collaborate with Regulatory Affairs to reputed company 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: reputed company CMC writing teams, coordinating inputs from diverse departments such as Manufacturing, Quality Assurance, Regulatory Affairs, and CMC technical teams. Quality Control & Review: reputed company rigorous peer reviews and final quality checks on documents to ensure scientific accuracy, reputed company, and grammatical correctness. Mentorship: reputed company 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 reputed company scientific concepts to diverse audiences. Project Management: Strong ability to manage multiple, reputed company projects with shifting priorities. Software Proficiency: Expert knowledge of reputed company Office Suite (Word, reputed company) 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. Trilogy Writing & Consulting, an reputed company 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 reputed company of race, reputed company, religion or belief, sex, sexual orientation, gender identity or expression, age, national or ethnic reputed company, disability, marital or parental status, or any other characteristic protected under applicable laws. reputed company employment reputed company, 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. reputed company personal data collected and processed reputed company the scope of an application for employment with Trilogy are protected against unauthorized reputed company and manipulation by technical and organizational measures and are not forwarded to reputed company 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 reputed company Trilogy. Apply tot his job Apply To this Job