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Code of Practice Compliance Manager and ZINC lead - United Kingdom  

Celgene (company)


Posted on : 26 December 2016

Project Description

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-compliance, and ensure the development and implementation of appropriate corrective and preventative actions to optimize compliance with company policies and procedures  
  • Act as the ZINC lead for the affiliate, liaising with ZINC-MAPs and relevant internal stakeholders to optimize 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 our company 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 company 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 company  written procedures
  • Manage withdrawal of promotional and non-promotional items as per company  written procedures 
  • Maintain a current list of items in use

Skills 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  

  • Our company  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.