Celgene Healthcare Compliance Manager in Hillingdon, United Kingdom

Description

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.

Summary

To provide oversight of and guidance on Celgene processes related to the ABPI and IPHA Codes of Practice, supporting affiliate training and compliance monitoring activities, and identifying opportunities for continuous improvement.

Role Responsibilities

  • Identify process gaps and solutions by continual review of existing Celgene healthcare compliance processes (global, regional and local).

  • Develop / maintain Code of Practice-related SOPs, in collaboration with the relevant internal stakeholders.

  • Develop and deploy a Continuous Process Improvement Plan: Define, manage and monitor Code of Practice-related Corrective and Preventative Actions, Compliance Incidents and root cause analysis, and Change Controls in collaboration with the Quality team.

  • Perform regular monitoring checks/self audits to ensure compliance with internal procedures and Codes of Practice, and report relevant metrics to affiliate management team and other relevant internal stakeholders.

  • Develop and deliver regular Code of Practice -related training sessions to the affiliate.

  • Provide support for internal /external audits/inspections for the UK/Ireland Affiliate in relation to Code of Practice activities in collaboration with the Quality team.

  • First-line point of contact for Code of Practice-related process questions for both the affiliate and above-country colleagues. Escalate queries where required and work with Quality and Compliance team, Final Signatories and Code of Practice Forum (as appropriate) to ensure timely responses/required solutions are delivered to internal stakeholders.

  • Coordinate Code of Practice complaints process in relation to inter-company disputes, PMCPA complaints and MHRA promotional complaints, working with internal stakeholders as appropriate.

  • To monitor legislation, guidelines and the national regulatory environment to maintain company intelligence and awareness of compliance and best practice within the affiliate.

Qualifications

  • Life science / Pharmacy degree.

Skills and Knowledge Requirements

  • Established knowledge of the quality management principles.

  • Experience and knowledge of the ABPI and IPHA Codes of Practice.

  • Experience of hosting and conducting audits and internal quality/compliance reviews.

  • Must be pro-active, self motivated, highly flexible team player.

  • Excellent negotiation skills.

  • Excellent written and verbal communication skills.

  • 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.

  • Appreciation of the reputation of the industry and an understanding of how to protect Celgene‚Äôs reputation.

*MONEU

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Healthcare Compliance Manager

Location: Hillingdon, England, UK

Job ID: 17000065