Health Care Compliance Specialist - Senior

Highly Competitive
  1. Contract
  2. Good Distribution Practice (GDP)
  3. United Kingdom
Wokingham, Berkshire
Posting date: 31 Jan 2019
QA.ZD.21321_1548934737

A new job opportunity has arisen for a Health Care Compliance Specialist - Senior position at one of the most globally renowned healthcare companies, that covers a range of industries from medical devices to pharmaceutical and consumer goods. ProClinical is advertising this position for a talented and hardworking individual to join the company in its Berkshire team, on a contract basis.

The Health Care Compliance Specialist will manage Healthcare Compliance programs transactions for the Health Care Compliance (HCC) organisation. They will support planning, training, assessing, testing, and other varied HCC functions. They will also be responsible for maintaining existing programs and implementing activities related to Management Action Plans.

Job Responsibilities:

  • Working with the Health Care Compliance team on various support activities.
  • Maintaining 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 harmonisation and implementation.
  • Assisting in software support for HCC software.
  • Assisting in the harmonisation, preparation, updating, and implementing of all HCC written policies and procedures on an ongoing basis.
  • Serving as the first line of communication to the business for reviewing local requests and documentation.
  • Assisting in implementation of modifying regional global strategies into regional and local levels and, where needed, sector levels, based on appropriate local needs, goals and objectives. This takes into account the local and external regulatory trends and environments.
  • Supporting the Implementation of Country or Cluster strategy & plan aligning with the businesses and company's Office of Compliance.
  • Supporting the HCC Officer in the self-assessment and risk assessment processes to detect process gaps & inconsistencies.
  • Supporting the implementation of local testing & monitoring plans to demonstrate that the HCC program is effective and participating in execution where appropriate.
  • Assisting in coordinating preparations for Corporate Internal Audits.
  • Assisting in the implementing and following up on the Management Action Plan, as assigned by the HCC Officer.
  • Reporting unplanned deviations and supporting the HCC Officer in Managing day-to-day inquiries, allegations, and investigations.
  • Implementing the escalation processes for serious allegations, as appropriate.
  • Collecting and Providing metrics to the HCC Officer and Operations group as assigned.
  • Representing HCC in Country Value Teams/marketing planning meetings.
  • Developing training for internal and external parties.
  • Liaising with legal department and external advisors.
  • Leading HCC projects and participating in regional, or cross-sector projects.
  • Partnering with the Global/Regional Operations team to implement business specific policies and SOPs, and customising global/regional policies & procedures and education, along with training materials to reflect local requirements.
  • Implementing IM systems that collect, audit, analyse, and report compliance information.
  • Deploying policies and procedures that align and monitor company activities to ensure compliance with government, private, legal, and company HCC standards.
  • Implementing HCC training programs, including new employee orientation, periodic training on specialised subjects, and annual refresher training.
  • Executing Testing and Monitoring plans and programs.
  • Ensuring external reporting requirements are met per local regulations.
  • Ensuring internal reporting requirements are met per enterprise requirements and schedules.

Skills and Requirements:

  • A BA/BS, advanced degree, or equivalent, along with a minimum of 2 years of business experience, preferably in Compliance.
  • Demonstrable experience in a related industry, such as HCC/GCC, Regulatory Affairs.
  • Demonstrable Compliance Experience in the Medical Device or Pharmaceutical industries.
  • Strong analytical skills, strong influencing skills, an ability to deal with complexity, strategic, and tactical thinking.
  • An ability to manage conflicts in an open and constructive manner.
  • Critical reasoning skills, focused on identifying and resolving complex problems.
  • Detail oriented with the ability to work independently and manage competing priorities.
  • Planning, organisational, and time management skills.
  • Professional interpersonal skills, excellent oral/written communication, and influencing skills.
  • An ability to work well between functions, and across all levels of the business and effective time management skills are essential.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Zico Dervish on +44 203 319 3031 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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