An independent pharmaceutical consultancy is seeking a Senior Regulatory Writers to support the Directors in leading the regulatory writing department.
Senior Regulatory Writer Role:
Lead the preparation of clinical and regulatory documents: Protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), Integrated Safety and Efficacy Summaries, Subject Consent Forms, Briefing Documents, Clinical Overviews, RMPs etc.
Work as part of a team to deliver projects in line with budgets and timelines.
Ensure high standards of quality on all documentation.
Senior Medical Writer Requirements:
Minimum 3 years of industry regulatory writing experience.
Varied therapeutic area background.
Highly proficient with styles of writing for various regulatory documents
Excellent understanding of industry regulations, Good Clinical Practices, and ICH guidelines
Masters or PhD in scientific, medical, clinical discipline preferred.
In return, you will be offered a starting salary of £45,000 - £55,000 per annum.
Interviews will be taking place from Monday 5th September so if this is of interest, please apply directly or message me on LinkedIn – Henry Shirlaw X4 Communications.
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