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Compliance Specialist

  • Job reference: 928722
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 18/11/2019

Orion Group Sciences are looking for a Compliance Specialist for our multinational pharmaceutical client based in the Buckinghamshire area on an initial 12-month contract with the potential to extend.

Job Purpose

The Health Care Compliance Specialist will work with the HCC team on various support activities. This position will report into the Pharma UK & Ireland HCC manager with a dotted line to the Cross-sector implementation HCC Specialist.

Main Responsibilities of the role

  • Organizing and implementing training on HCBI and HCC Local regulations
  • Maintain employee certification and training attendance records
  • Assisting in HCC reviews and approvals
  • Carrying out day-to-day tasks such as data collection, analysis and reporting, supporting new procedure harmonization and implementation, assisting in software support for HCC software and assist in the harmonization, preparation, updating and implementation of all HCC written policies and procedures on an ongoing basis
  • May serve as the first line of communication to the business for reviewing local requests and documentation
  • Assist in implementation of modifying regional global strategies into regional and local level and where needed sector level, based on appropriate local needs, goals and objectives, taking into account local external regulatory trends and environment
  • Support Implementation of Cluster strategy & plan aligning with the businesses and Office of Compliance
  • Support the HCC operations group in implementation of education, training, and regular communications on HCC to all covered employees, including local sales, marketing, finance, HR, managers, supply chain and directors at the local level
  • Support the HCC Officer in the self-assessment and risk assessment processes to detect process gaps & inconsistencies
  • Support the implementation of local cross sector testing & monitoring plan to demonstrate that the HCC program is effective and participate in execution where appropriate
  • Support the Cross Sector implementation HCC Specialist in his cross sector activities: Monitoring, Due Diligence of third parties, Solutions & Services and other ad-hoc activities agreed with the Pharma HCC Officer
  • Assisting in coordinating preparations for Corporate Internal Audits
  • Assist in the implementing and following up on the Management Action Plan as assigned by the HCC Officer
  • Report unplanned deviations and supporting the HCC Officer in Managing day-to-day inquiries, allegations and investigations
  • Implement the escalation process for serious allegations, as appropriate
  • Collect and Provide metrics to the HCC Officer and Operations group as assigned
  • Represent HCC in Country Value Teams/ marketing planning meetings
  • Conduct training for internal and external parties
  • Ensure cross-sector alignment

Desired Experience and Background of the successful candidate

  • BA/BS, advanced degree or equivalent preferred
  • Minimum of 2 years' business experience. Preferable experience in Compliance
  • Deals well with ambiguity and demonstrates strong organizational, process and interpersonal skills.
  • Ability to work well between functions and across all levels of the business and effective time management skills is essential.
  • Basic level Word & Excel essential. Basic level PowerPoint & intermediate level Excel desirable
  • Requires strong communication, organisational and analytical skills; must be able to work independently
  • Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Regulatory or Auditing
  • Proven track record in delivering results, self-starter and ability to manage complexity a must
  • Industry related experience preferred: HCC, Regulatory Affairs, and Compliance Experience in the Pharmaceutical and Medical Devices industries
  • Advantage if familiar with the ABPI Code and potentially with IPHA Code
  • Ability to manage conflicts in an open and constructive manner; Strong analytical skills, strong influencing skills, ability to deal with complexity, strategic and tactical thinking
  • Strong analytical skills, strong influencing skills, ability to deal with complexity, strategic and tactical thinking

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.