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Code of Practice Compliance Manager and ZINC lead United Kingdom,  

Posted on : 26 December 2016

Project Description

Req #: 16001997 Location: Hillingdon, England UK Job Category: Regulatory Affairs Work Location: Stockley Park, UK 1 Longwalk Road Stockley Park Hillingdon UB11 1DB Organization: Celgene UK Marketing LTD Schedule: Full-time Shift: Day Job Employee Status: Regular Job Type: Standard Job Level: Manager Travel: No Description Role and Responsibilities: " Conduct regular monthly audits on promotional, non-promotional and examination materials and activities from both a quality and SOP/WP-compliance perspective (to include ZINC, FAST and hard-copy archiving records) " Identify non-compliances, and ensure the development and implementation of appropriate corrective and preventative actions to optimise compliance with Celgene policies and procedures " Act as the ZINC lead for the affiliate, liaising with ZINC-MAPs and relevant internal stakeholders to optimise and enhance the use of ZINC for the UK/Ireland affiliate " Single Point of Contact for changing access rights in ZINC " Conduct regular ZINC training sessions: responsible for  training all new users (including agency partners) on ZINC  at Celgene, implement and run a monthly ZINC clinic to assist users with ZINC issues and run training sessions as required to raise awareness of ZINC functionalities and changes following any upgrades " Provide regular ZINC and FAST metrics on the performance of the UK/Ireland Affiliate in relation to activities/material review and approval. Inform Code of Practice Compliance Forum of trends and significant issues at each meeting " Provide support for internal /external audits for the UK/Ireland Affiliate in relation to Code of Practice activities " Coordinate the Code of Practice complaints process in relation to inter-company disputes, PMCPA complaints and MHRA advertising/promotional complaints, working with internal stakeholders as appropriate " Serve as a first-line point of contact on questions from colleagues regarding Celgene Code of Practice-related processes. Escalate questions where required and work with final signatories and the Code of Practice Compliance Forum (as appropriate) to ensure that timely responses are delivered " Responsible for the development/maintenance of Code of Practice-related work practices and job aids in collaboration with the relevant internal stakeholders " Manage the hard-copy archiving process in accordance with Celgene written procedures " Manage withdrawal of promotional and non-promotional items as per Celgene written procedures " Maintain a current list of items in useQualificationsSkills and Knowledge Requirements:   " Previous pharmaceutical industry experience is essential with significant experience and knowledge of the ABPI and IPHA Codes of Practice. " Previous experience/knowledge and understanding of quality systems, processes, audit and inspection is desirable " Must be pro-active, self motivated, highly flexible team player " Excellent assertiveness, persuasion and negotiation skills " Excellent written and verbal communication skills including strong interpersonal skills " Ability to understand laws, codes and policies and the need to translate into practical, workable procedures and clear guidance for all involved " Effective problem solving skills " Excellent time management and planning / organisational skills with the ability to work to strict timelines and handle multiple priorities / deadlines without losing attention to detail " Experienced ZINC user " Appreciation of the reputation of the industry and an understanding of how to protect  Celgene s reputation Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. *LI-KL1 *MONEU 


Hillingdon England UK

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