Applicants will work in the Durham, NC office. Remote candidates will also be considered. Freelancers need not apply.

Candidate must have the following writing experience:

  • At least 10 years experience actively writing regulatory documents.
  • Worked as the lead writer on >5 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications, PSUR or DSUR, PBRER, RMP, or PIP.
  • Experience in at least 2 different types of CTD dossiers (i.e. full new chemical entity application, a variation, a generic dossier, an orphan drug dossier, a literature-based dossier [e.g. a full-mixed application under Article 8(3) of Directive 2001/83/EC]).
  • Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
  • Ability and willingness to take on any project for which a Lead Writer is needed.
  • Competency in the use of document management systems and associated tools.

In addition to having the above writing experience, applicants must have:

  • Masters/Bachelors degree in science/pharmacy (PhD not necessary).
  • Fluent written and spoken English skills.
  • An appreciation for a well written document and an eye for details.
  • Excellent, proven interpersonal skills and enjoy proactively participating on a team with diverse personalities.
  • Flexibility and the ability to stay focused under tight timelines.

As a Principal Medical Writer, you will

  • Prepare a variety of clinical regulatory documents (as described above) as the lead writer 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 on documents under your responsibility.
  • Project manage the timelines and review cycles of your documents.
  • Work in the client’s regulatory document management systems.

At Trilogy Writing you will be part of a team that provides a service to clients of more than just writing. Our writers are integral parts of clinical development teams with worldwide pharmaceutical companies. We assist those teams in writing and coordinating successful documentation across a broad spectrum of therapeutic areas, whether it is for regulatory submission packages or for publication in scientific journals. As a growing company, 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 look at our website.

If you are interested in exploring where your own creative input can take you, contact us. For further information about the position, feel free to call Gretchen Griffin at +1 984 260 3631.

To apply, please write in English, specifying how you comply with the experience requirements, with your CV to Pamela Jes Fernandez at jobs(Replace this parenthesis with the @ sign) . Applicants who do not have the experience specified above will not be considered.