Senior Medical Writer

1 month ago

United Kingdom Life Sciences Recruitment Full time

As a Senior/Principal Medical Writer, You Will


  • 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 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.


The Candidate Must Have The Following Writing Experience


  • At least 3 years of experience actively writing regulatory documents.
  • Worked as the lead writer on >3 (Senior Medical Writer) or >5 (Principal Medical Writer) of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs.
  • For the Principal Medical Writer level, 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]).
  • For the Principal Medical Writer level, ability and willingness to take on any project for which a Lead Writer is needed.
  • 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 review 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 detail.
  • Excellent, proven interpersonal skills and enjoy proactively participating on a team with diverse personalities.
  • Flexibility and the ability to stay focused under tight timelines.

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