Senior​/Principal Medical Writer

Overview

Join to apply for the Senior/Principal Medical Writer - USA role at Trilogy Writing & Consulting, An Indegene Company
. Trilogy Writing & Consulting, an 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.

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

If this excites you, then apply below.

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); may work either fully remotely or a hybrid schedule (in office/remote) from our Durham, NC, USA office.

• Preparing 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 members of client authoring teams and supported by other writers, as appropriate.
• Ensuring 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.
• Providing document-specific advice to clients.
• Overseeing and coordinating other writers and QC specialists assisting on documents under your responsibility.
• Project managing the timelines and review cycles of your documents.
• Working in the client’s regulatory document management systems.

• Function as a lead writer to 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) in collaboration with members of client authoring teams and supported by other writers, as appropriate.
• Ensure 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.
• Be responsible for providing 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.

• A minimum of a Bachelor’s degree in science/pharmacy (Ph.D. not necessary).
• Fluent written and spoken English skills.
• 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.
• Must have worked as the lead writer on key regulatory document(s) such as:
  Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications.
• For Principal Medical Writer, must 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.
• 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.
• An appreciation for a well-written document and an eye for details.
• Excellent, proven interpersonal skills, and enjoy proactively participating on a team with…