Trilogywriting
Senior/Principal Medical Writer - USA
Trilogywriting, Durham, North Carolina, United States, 27703
Overview
Trilogy Writing & Consulting, an Indegene Company, is hiring Senior/Principal Medical Writers (USA) to support regulatory documentation for the international pharmaceutical industry. Our writers are integral members of clinical development teams, delivering writing and coordination of successful documentation across a broad spectrum of therapeutic areas. As our company continues to expand, there is room to develop with us, and your ideas will form our future together. For further insight into who we are and what we do, please explore our website (www.trilogywriting.com). Eligibility
Applicants must live in the USA and be authorized to work for any employer in the USA; we are unable to sponsor or take over sponsorship of an employment visa at this time.
Candidates may work either fully remotely or on a hybrid schedule (in‑office/hybrid) from our Durham, NC office. Responsibilities
Prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) as the lead writer in collaboration with client authoring teams and supported by other writers. Ensure all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy and our clients. Provide document‑specific advice to clients. Oversee and coordinate other writers and QC specialists assisting with documents under your responsibility. Project manage the timelines and review cycles of your documents. Work in the client’s regulatory document management systems. Qualifications
Minimum Bachelor’s degree in science or pharmacy (Ph.D. not required). Fluent written and spoken English skills. 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 (CTD), Investigator Brochures, IMPDs/INDs, and scientific publications. For Principal Medical Writer: experience as lead writer on multiple‑document projects with 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 of the documents, coordinating review cycles, meetings, and project timelines. In‑depth knowledge of relevant regulatory guidance (e.g., ICH, FDA, EMA) for clinical trial conduct, including document‑specific guidance. Competency in the use of document management systems and review tools. An appreciation for a well‑written document and an eye for detail. Excellent interpersonal skills and ability to work proactively on a diverse team. Flexibility and ability to stay focused under tight timelines. Perks
Competitive base salary ($120,000‑$159,000 USD; estimate, may vary based on experience, region, and compensation practices). Annual bonus opportunity. A generous allowance of paid time off (vacation, holiday, birthday, illness). Comprehensive benefits plans: medical, dental, vision, disability, life insurance with AD&D. 401(k) retirement savings plan with company match. Full AMWA membership and annual conference attendance paid by Trilogy. Continuous personal and professional development opportunities. Free weekly yoga sessions and other fun events that encourage team bonding. Equal Opportunity
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, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other protected characteristic. All employment decisions, from hiring to separation, will be based on business requirements and the candidate’s merit and qualification. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
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Trilogy Writing & Consulting, an Indegene Company, is hiring Senior/Principal Medical Writers (USA) to support regulatory documentation for the international pharmaceutical industry. Our writers are integral members of clinical development teams, delivering writing and coordination of successful documentation across a broad spectrum of therapeutic areas. As our company continues to expand, there is room to develop with us, and your ideas will form our future together. For further insight into who we are and what we do, please explore our website (www.trilogywriting.com). Eligibility
Applicants must live in the USA and be authorized to work for any employer in the USA; we are unable to sponsor or take over sponsorship of an employment visa at this time.
Candidates may work either fully remotely or on a hybrid schedule (in‑office/hybrid) from our Durham, NC office. Responsibilities
Prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) as the lead writer in collaboration with client authoring teams and supported by other writers. Ensure all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy and our clients. Provide document‑specific advice to clients. Oversee and coordinate other writers and QC specialists assisting with documents under your responsibility. Project manage the timelines and review cycles of your documents. Work in the client’s regulatory document management systems. Qualifications
Minimum Bachelor’s degree in science or pharmacy (Ph.D. not required). Fluent written and spoken English skills. 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 (CTD), Investigator Brochures, IMPDs/INDs, and scientific publications. For Principal Medical Writer: experience as lead writer on multiple‑document projects with 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 of the documents, coordinating review cycles, meetings, and project timelines. In‑depth knowledge of relevant regulatory guidance (e.g., ICH, FDA, EMA) for clinical trial conduct, including document‑specific guidance. Competency in the use of document management systems and review tools. An appreciation for a well‑written document and an eye for detail. Excellent interpersonal skills and ability to work proactively on a diverse team. Flexibility and ability to stay focused under tight timelines. Perks
Competitive base salary ($120,000‑$159,000 USD; estimate, may vary based on experience, region, and compensation practices). Annual bonus opportunity. A generous allowance of paid time off (vacation, holiday, birthday, illness). Comprehensive benefits plans: medical, dental, vision, disability, life insurance with AD&D. 401(k) retirement savings plan with company match. Full AMWA membership and annual conference attendance paid by Trilogy. Continuous personal and professional development opportunities. Free weekly yoga sessions and other fun events that encourage team bonding. Equal Opportunity
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, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other protected characteristic. All employment decisions, from hiring to separation, will be based on business requirements and the candidate’s merit and qualification. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
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