Compliance Lead

Recruiter
Just Pharma
Location
Cambridgeshire
Posted
31 Jan 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Just Pharma are assisting a mid-sized pharma company based in Cambridgeshire to recruit a Compliance Lead to work in their Clinical R&D department. This is a full time, office-based position. REQUIREMENTS The successful candidate will: * Work in conjunction with Clinical R&D Directors to develop and implement strategy, ensuring all operational activities follow all GxP regulatory standards. * Support and monitor compliance with internal processes and systems. * Generate compliance metrics for reporting to Clinical R&D Directors, GCP compliance forum, and the Quality Steering Group. * Be the named GCP archivist for clinical R&D – oversee internal archiving as well as external archiving for investigator sites. * Liaise with global counterparts to ensure strategic alignment. * Be involved with the preparation, coordination and action planning of activities relating to internal and external audits for clinical R&D. * Develop, review and maintain department procedures and SOPs. * Be involved with internal and external training. The ideal candidate will: * Have a proven knowledge of current legislation. * Have strong project management skills as well as CRO/CMO oversight. * Strong experience in eTMF essential. * Must have strong knowledge of the drug development process. * Good knowledge of clinical R&D and compliance activities.

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