Senior/Principal Medical Writer - USA
Durham, North Carolina, United StatesAll locationsDurham, North Carolina, United StatesUSA Hybrid
$159–$120,000 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
Trilogy Writing & Consulting, a n Indegene Company, is hiring Senior/Principal Medical Writers (USA) to support our growing company in producing regulatory documentation for the international pharmaceutical industry. At Trilogy, you will play a pivotal role in delivering comprehensive services to our clients that extend beyond writing. Our writers are integral members of clinical development teams supporting the 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). If this excites you, then apply below.
What you'll bring
- Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications.
- Ensur ing that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company’s clients.
- A minimum of 3-5 years of experience of actively writing regulatory documents
- experience as a lead writer on CTD documents is required for Principal Medical Writer.
- For Principal Medical Writer, m ust have experience as the lead writer with multiple-document projects with global, multinational teams, including team management, project management, review management, and budget oversight.
- Must be able to manage multiple projects simultaneously.
- Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
- Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
- Must have in-depth working knowledge of the relevant regulatory guidance ( e.g. ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance.
- For Principal Medical Writer, Experience in multiple therapeutic areas to have confidence to work in these areas without lead-in time.
- Competency in the use of document management systems and review tools.
- For the Principal Medical Writer level, ability and willingness to take on any project for which a Lead Writer is needed.