Accessibility Links

Health Care Compliance Specialist

  • Job reference: 923414
  • Location: Wokingham, Berkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 17/01/2019

Orion Group are recruiting for a Health Care Compliance Specialist on behalf of our Multinational Medical Devices Client on an initial 6 month contract based in the Berkshire Area.

The Health Care Compliance Specialist manages Healthcare Compliance programs transactions for the Health Care Compliance organization. He or she supports planning, trainings, assessments, testing and other varied HCC functions. This person is also responsible for maintaining existing programs and implementing activities related to Management Action Plans.

PROFILE:
* Position reports into the Enterprise Wide compliance organization
* Requires strong communication, organisational and analytical skills
* Must be able to work independently
* Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Pharmacovigilence, Regulatory or Auditing.
* Proven track record in delivering results, self-starter and ability to manage complexity a must
* Industry related experience preferred: HCC/GCC, Regulatory Affairs, and Compliance Experience in the Medical Device or Pharmaceutical industries.
* 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

ESSENTIAL DUTIES AND RESPONSIBILITIES

The Health Care Compliance Specialist will work with the HCC team on various support activities which may include but not be limited to the following:
* Organizing and implementing training
* 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
* 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, taken into account local external regulatory trends and environment
* Support Implementation of Country or 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 testing & monitoring plan to demonstrate that the HCC program is effective and participate in execution where appropriate
* 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
* Develop training for internal and external parties
* Liaise with legal department and external advisors
* Lead HCC projects and participate in regional or cross-sector projects
* Improve working methods

* Partnering with the Global/Regional Operations team to:
o Implement business specific policies and SOP's and customize global/regional policies & procedures and education & training materials to reflect local requirements
o Implement IM systems that collect, audit, analyse, and report compliance information
o Deploy policies and procedures that align and monitor company activities to ensure compliance with government, private, legal and company HCC standards
o Implement HCC training programs, including new employee orientation, periodic training on specialized subjects, and annual refresher training
o Execute Testing & Monitoring plans and programs
o Ensure external reporting requirements are met per local regulations
o Ensure internal reporting requirements are met per enterprise requirements and schedule
Level: PG 25

* EDUCATION and EXPERIENCE: BA/BS, advanced degree or equivalent preferred and a minimum of 2 years business experience. Preferably experience in Compliance.

* OTHER SKILLS and ABILITIES: 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 are essential. Ability to work independently and in a detailed manner. Ability to work well in teams.


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.