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Health Care Compliance
Requisition ID: 1700214314W
Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
J&J Medical Devices enables hospitals and healthcare organizations to optimize their activities with innovative medical products, tools and services. The company is one of the largest suppliers of hospitals in Iberia. Medical Devices headquarters are also in Madrid and Lisbon and it has around 550 employees in Operations, Services and Sales & Marketing.
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The Health Care Compliance Specialist will work with the HCC Officer on various support activities which may include but not be limited to the following:
- Organizing and implementing training as required by the local training plan
- 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,
- Assist in the harmonization, preparation, updating and implementation of all HCC written policies and procedures on an ongoing basis
- Serve as the first line of communication to the business for reviewing local requests and documentation.
- Assist in the implementation of new or modified regional global strategies into local level, based on appropriate local needs, goals and objectives, taking into account local external regulatory trends and environment
- Support the implementation of Country or Cluster strategy & plan aligning with the businesses, Franchise Liaison Officers and HCC Central Team
- 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
- Assist in the preparation for Corporate Internal Audits
- Assist in the implementation and follow up of 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 as assigned
- Represent HCC in sales & marketing planning meetings or any other business meetings as required
- Assist to develop training for internal and external parties
- Liaise with legal department and external advisors
- Participate in local MD&D or cross-sector projects as required
- Assist in improving working methods
- Partnering with the local lead in contact with the Global/Regional Operations team to:
-Assist implementing business specific policies and SOP's and customize global/regional policies & procedures and education & training materials to reflect local requirements
- Assist in the deployment of policies and procedures that align and monitor company activities to ensure compliance with government, private, legal and company HCC standards
- Assist implementing HCC training programs, including new employee orientation, periodic training on specialized subjects, and annual certification training
-Execute Testing & Monitoring plans and programs
-Ensure that external reporting requirements are met per local regulations
-Ensure internal reporting requirements are met per enterprise requirements and schedule.
Position reports into the Health Care Compliance Officer
- Requires significant communication, organizational and analytical skills
- Must be able to work independently
- Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Pharmacovigilance, 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 is desirable
Education and Experience:
BA/BS, advanced degree or equivalent and a minimum 1 year experience in Compliance is preferred. Abillity to make things happen through managing a broad set of Credo based values. Understands the J&J Credo based culture.
Other skills and abilities:
Deals well with ambiguity and complexity and demonstrates good 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. Ability to manage conflict in a positive way.
Spain-Community of Madrid-Madrid
Johnson & Johnson, S.A. (8500)
Health Care Compliance