Regulatory Affairs - Principal Medical Writer

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Job Details

Responsibility

:

• 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 the company 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.

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.
• 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

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info

Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
United Kingdom
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