One of our leading international drug development clients has a job opening for a Senior Regulatory Writer for their Clinical Team. This position can be based out of their UK/EU offices, or full time remote in the UK, Germany or the Netherlands.
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Senior Regulatory Writer (SRW) is a major contributor to document authorship for a variety of documents across different service lines. The SRW will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team. We are looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals.
- Lead or participate in a project team which may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer
- Author documents per client specifications, templates, style guides, and other guidance documents
- Author documents per regulatory authority guidelines and requirements
- Act as client advisor, working with all parties to lead development of strategies for organizing and preparing regulatory documents
- Bachelor’s degree
- 3-5+ years of regulatory writing experience or equivalent experience with clinical related documentation
- Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
- Experience in the development of submission-level documents (does not require functioning as a document lead)
- Experience in the development of clinical documents such as Clinical Study Reports, Investigator Brochures, protocols ISS and/or ISE
- Strong understanding of the document creation process and of the drug development lifecycle
- Able to synthesize data across multiple data sources and documents to create summary reports
ORGANISATION AND OFFER
As their Regulatory Science division, this company accelerates the regulatory submissions of medical innovations worldwide through customized regulatory solutions, including strategy, communications, operations and technology. This company is comprised of some of the most respected talent in the industry, including thought leaders, writers and editors, and regulatory submissions specialists. Our people are talented, quality-minded, and client and stakeholder-oriented.
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme? Check this LINK
For more information, please contact Ralph Looijen on +31 (0)20 20 44 502