Principal Medical Writer - Clinical & Regulatory Writing
- Employer
- Barrington James
- Location
- England (GB)
- Salary
- Negotiable
- Start date
- 23 Apr 2021
- Closing date
- 30 Apr 2021
View more
- Discipline
- Clinical Research, Medical Communications, Medical Writing
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
Applicants will work in the Cambridge, UK 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 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.
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.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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