At Johnson & Johnson' we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented' treated' and cured' where treatments are smarter and less invasive' and solutions are personal. Through our expertise in Innovative Medicine and MedTech' we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow' and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Legal & Compliance
Job Sub Function:
Health Care Compliance
Job Category:
Professional
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Job Description:
HCC Officer EMEA MedTech Regional Offices
Location: EMEA
Contract: Full Time
Overall' Purpose of this job:
The HCC Officer EMEA MedTech Regional Offices drives the Healthcare Compliance (HCC) program for EMEA Vision Regional Offices and R&D to ensure business practices and activities are in compliance with related J&J internal guidelines' laws' regulations and industry codes (MedTech Code) and anti-corruption laws including the Foreign Corrupt Practices Act.
The HCCO serves as a strategic business partner for management and acts as a coach for all covered employees assuring a company culture of compliance is a natural element in day-to-day business. The HCCO supports planning' trainings' assessments' testing & monitoring and other HCC activities for EMEA Vision.
This position reports to the HCC Director EMEA MedTech Regional Offices.
Key Responsibilities: include the following. Other duties may be assigned:
Partner with the EMEA Vision to ensure that the HCC program effectively prevents and/or detects violations of law' regulations' policies' or the Code of Conduct. That includes but is not limited to:
- Assuring adequate representation in relevant business governance structures e.g.' management board and establish discussion platforms to get general business alignment and impact analysis.
- Communicating on status of the HCC program regularly to the line manager and the relevant board(s).
- Translating global HCC strategies into EMEA Vision strategy based on appropriate needs' goals' and objectives' considering EMEA external regulatory trends and environment. Develop and coordinate the implementation of EMEA strategy' aligning with the businesses and J&J HCC.
- Stimulating and supplying innovative ways towards HCPs and GOs consistent with the HCC/HCBI guidelines and framework and performing business plan reviews.
- Ensure disclosure requirements of MedTech Europe and local legislation are met.
- Develop and provide appropriate guidance' procedures' education' training' and regular communications on HCC to business partners.
- Conducting self-assessment and risk assessment processes to detect process gaps & inconsistencies.
- Drive the establishment of the Management Action Plans and guide the business partners to close gaps and implement corrective actions.
- Developing a testing & monitoring plan to demonstrate that the HCC program is effective and participate in execution where appropriate. Engage EMEA Vision executive leaders' participation in roll out.
- Support the preparation of Corporate Internal Audits.
- Consults on HCC matters' policies' and procedures with business partners. Perform HCC reviews & approvals for HCP/HCO/GO related activities as required.
- Participating in and leading investigations of non-compliance and implementing the escalation process for allegations' as appropriate
- Collaborate with direct EMEA HCCO colleagues as well as with Vision HCCOs globally to ensure EMEA Vision and global alignment.
- Partner with the Global/Regional Operations team.
- Collaborate with Legal and Privacy regarding HCC and Privacy requirements and interpretation.
Experience requirements and qualifications:
- University Bachelor's degree or equivalent / MBA is preferred.
- Minimum of 5 years of business experience is required.
- Background and experience may include Compliance' Finance' Sales and Marketing' Medical Affairs' Legal' Pharmacovigilance' Regulatory or Auditing.
- Knowledge of regulations and industry standards of the Medical Devices market (i.e. MedTech Code).
- Experience in Health Care Compliance is preferred.
- Strong communication' organizational and analytical skills.
- Ability to cultivate relevant relationships and lead internal collaboration across the company' influencing business decisions and business partners across all functions and levels of the business.
- Ability to take sophisticated business situations and develop solutions to ensure compliant growth is achieved.
- Consistent track record in delivering results.
- Ability to work independently and in a detailed manner.
- Committed team player.
- Understands and masters the J&J Credo based culture.
- Ability to comprehend and interpret legal documents would be an advantage.
- Very good command of the English language both verbal and written' including presentation skills.
- Travel: 15-20% of the time mainly in EMEA.