Our client, an innovative and dynamic pharmaceutical company, are seeking a Regulatory Writer to prepare documents such as clinical study reports, Investigator Brochures, Annual Updates, CTD tabular summaries in line with regulatory requirements and internal document standards.
This Regulatory/Medical Writer role will give you exposure to a wide range of regulatory documents including:
- Preparation of more complex regulatory documents (e.g. CTD Overviews, ISS/ISE, clinical and non-clinical regulatory responses, product labelling and post marketing documentation) as required with direction from other members of the team.
- Tracks and manages progress of CTD documentation.
- Contributes to other non-regulatory medical writing activities as required.
- Contributes to development work in relation to document standards, template development, SOPs and other aspects of document management.
- Oversees the activities and performance of external vendors (e.g. CROs) by defining writing requirements, evaluation of CRO proposals/contractual documentation, acting as interface between our client and CRO, review of Project Plan(s), tracking of deliverables etc.
- Represent the Medical Writing function for assigned tasks on internal Clinical Project Teams.
If you would like more information about this role, please contact Jonathan Hart-Smith on 01438 743047 or Email email@example.com . Alternatively, to apply, please click here.
CK Clinical Statement
By working with CK Clinical you can take advantage of our large network of contacts built upon our reputation of honesty and integrity. We will be pro-active on your behalf to introduce you to the right people in the right places. CK Clinical can offer Careers advice, help with writing your CV, assistance with your interview preparation and up to date information about the industry.
For an informal chat call Jonathan on Tel No. 01438 743047 or Email firstname.lastname@example.org. All enquiries will be dealt with complete discretion.