Senior Medical Writer

2 months ago

London, United Kingdom X4 Group Full time

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.

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