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Principal Regulatory Writer

Business Type: Medical Communications Agency
Job Type: Medical Communication
Job Level: Experienced (non manager)
Position: Full Time
Location: United Kingdom
Reference: PRW
Job Details:

As part of our ambitious expansion plans, we are looking for a Principal Regulatory Writer to join our successful team. Our Principal Regulatory Writer will lead the planning and delivery of regulatory submissions and other large regulatory projects, prepare clinical regulatory documents in a diverse range of therapy areas for our pharmaceutical clients, and be able to evaluate scientific data objectively, in order to describe results and scientific concepts in a concise and accurate manner. 


Bioscript Regulatory is part of the Bioscript Group, an international, independent agency group, driving continuous improvement in healthcare standards and outcomes through inspirational scientific communications. We provide a full range of medical communication solutions, including specialist health economic and regulatory writing services, meeting and event support as well as a range of publication and digital services. Because we believe in enabling our employees to do what they do best, we recruit for excellence in specialised areas and provide many opportunities for personal and professional development. Based in East Cheshire, Bioscript has grown steadily since inception in 2005, adding new clients and talented new staff every year.


Why Bioscript?
  • Science is at the core of everything we do.
  • We offer the opportunity to learn from regulatory/medical communications experts.
  • We take pride and ownership in the quality of our work.
  • We have a genuine focus on employee well-being.
  • We maintain a flexible working environment to help our team achieve a sensible work/life balance.
  • We offer a friendly, supportive and engaging environment in which individuals can thrive.


We are looking for candidates with drug-development experience, relevant to the field of regulatory writing. You will need a strong scientific background, including a minimum of a BSc (or equivalent) in an appropriate scientific discipline. You must have excellent written and spoken English skills, and a good working understanding of clinical development and ICH guidelines for regulatory documents. You should hav authored a range of regulatory documentation including common technical document (CTD) modules, and regulatory briefing and response documents.  Experience of leading regulatory submissions is essential; and experience of line management would be advantageous.


Attracting and developing talent is key to our success and we will support you every step of the way to reach your full potential.


Bioscript is committed to promoting a diverse and inclusive community - a place where we can all be ourselves and succeed on merit.


All offers of employment are subject to the candidate''s ability to provide suitable documentary evidence of their right to work in the UK.

Posted: 05/04/2021 | NPJ Ref: 268676
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