Senior Medical Writer - London, United Kingdom - X4 Group

X4 Group

Verified Company

London, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Join an international regulatory consultancy as a Senior Medical Writer and support the Head of Department in creating a broad range clinical and regulatory documents for global submissions.

The Company:

Senior Medical Writer Responsibilities:

Create and update regulatory documentation for submission to regulatory authorities according to appropriate regulations, standards, guidelines (ICH and GXP), and company/client requirements, keeping to agreed timelines.
Documents include Study Protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFS), Clinical Study Reports (CSRs), Clinical Overviews, Integrated Summaries of Safety and Efficacy, IMPDs, NDAs, BLAs, MAAs etc.
Collaborate with interdisciplinary teams, international client functions, vendors, publishing, and Regulatory Consultants
Ensure consistency, completeness, and adherence to agency guidelines, internal/client work instructions and SOPs throughout regulatory documentation
Stay current with industry practices, regulatory requirements, and medical developments that affect regulatory medical writing.
Evaluate, contribute to and review SOPs, guidelines, and work instructions to ensure regulatory documentation are standardised and adhere to relevant guidelines
Conduct literature searches to support Regulatory Applications.

Salary:
£50,000-£60,000 per annum DOE.

If this role isn't what you're looking for don't worry. At X4 Communications we cover all permanent and contract positions, with specialist industry sector teams.

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