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Manager Healthcare Compliance Process Endon United Kingdom,  

Posted on : 13 May 2017

Project Description

We have an opportunity for an experienced Pharma Healthcare Compliance Specialist to take responsibility as a Manger,  ensuring our healthcare compliance processes, policies and procedures  are fit for purpose within our EMEA region, consistently reviewed and aligned to our Global guidelines as appropriate.   In order to facilitate this role, candidates will as a minimum, be able to demonstrate experience and knowledge of UK regulations (particularly in respect of the ABPI & MHRA & Transparency) and have worked with regions in central Europe.   Purpose of the Position: Collaboratively drives the provision of Healthcare Compliance policies and processes at a local and EMEA regional level  (including for global activities) in order to ensure compliant and efficient operations with regards to applicable laws, regulations, Codes of Practice and Astellas policies and processes   Key activities: Compliance: •Embed Compliance Culture across all Regions ensuring Integrity in Action is actively applied in all initiatives.   •Promote adherence to Astellas policies relating to healthcare compliance standards in interactions with Healthcare Professionals (HCPs), Healthcare Organisations (HCOs) and Patient Organisations (POs).   Core Tasks •Take responsible for developing, reviewing, revising and implementing HCP policies, procedures and systems ensuring we maintain standards required by Astellas, the MHRA,ABPI and other applicable Codes of Practice •Develop and manage systems to ensure the maintenance of documentation for adherence •Share best practice policies, procedures and guidance with EMEA affiliates and work with the Compliance Operations team, supporting the development of training materials and training needs  and monitoring completion as appropriate (includes Affiliates, final signatories & vendors as appropriate) Act as a subject matter expert for Global processes that impact EMEA region •Maintain knowledge of Affiliates codes of practice case reports as applicable and implements required changes in relevant Healthcare Compliance policies and procedures as required •Play a key role in the implementation of annual and long-term strategic plans for Healthcare Compliance processes and implement controls on activities to prevent inappropriate conduct where applicable   Requirements for the role: •             Previous pharmaceutical industry experience within a medical, regulatory, pharmacovigilance, GCP, compliance environment •             Previous Healthcare Compliance experience within the UK with the ABPI Code of Practice •             Experience in regulatory requirements within the pharmaceutical industry •             Active involvement in Code (ABPI) related issues •             Experience in the creation of company policies, processes and procedures within a Quality framework.  Able to lead and plan the               deployment of effective processes •             Strong communication and collaboration experience with stakeholders and proven ability to influence and engage within a matrix                 environment  •             Fluent in written and verbal business English   Location: Hillswood


Hillswood United Kingdom

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