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Senior / Principal Regulatory Writer

4 months ago

Liverpool, United Kingdom Barrington James Full time

SENIOR MEDICAL WRITER (Germany, UK, USA, Canada, Portugal, Italy, Ireland)

Only candidates who meet the following requirements will be considered:

  • Candidate must live in one of the following countries: Germany, UK, USA, Canada, Portugal, Italy, Ireland. Applicants will work from one of our offices (Frankfurt, Germany; Cambridge, UK; Durham, NC, USA) or fully/partially remotely. Freelancers need not apply.
  • Submission of documents in English:
  • Cover letter specifying how you comply with the experience requirements listed below
  • CV

The candidate must have the following writing experience:

  • At least 5 years of experience actively writing regulatory documents.
  • Worked as the lead writer on >3 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.
  • Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
  • Competency in the use of document management systems and associated tools.

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

  • Diploma/Masters/Bachelor’s degree in science/pharmacy (Ph.D. 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 Senior 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.

Remuneration will be relative to the level of experience, with all standard Trilogy benefits.