Senior Regulatory Writer

4 weeks ago

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: Durham, NC, USA) or fully/partially remotely. Freelancers need not apply.
Submission of documents in English:
The candidate must have the following writing experience:
At least 5 years of experience actively writing regulatory documents.
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.
In addition to having the above writing experience, applicants must have:
Diploma/Masters/Bachelor’s degree in science/pharmacy (Ph.Fluent written and spoken English skills.
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.
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. For further insight into who we are and what we do, please look at our website.

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