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Posted on : 20 June 2017
- The Manager, Compliance Operations position reports to the Senior Director, Compliance Operations and Strategy and provides operational and organizational support to the company s global Legal and Compliance department.
- He/she is responsible for a variety of compliance-related activities including, but not limited to ensuring the effective operation of the EUROW compliance monitoring program, and the EUROW transparency program, in close collaboration with Legal & Compliance colleagues.
- Additional responsibilities in support of policy and process development, training & implementation, as well the review and approval of HCP engagements are core to this role.
- The Manager, Compliance Operations role reports to the Senior Director, Compliance Operations and Strategy, providing operational support primarily to EUROW employees involving compliance policies and procedures, focusing on key elements of training, compliance monitoring as well as company transparency & aggregate spend obligations. The individual will proactively engage with multiple stakeholders with solution focused approach to succeed in this role.
- Work with Sr. Director, Compliance Operations & Strategy and Sr Corporate Counsel, EUROW to conduct appropriate risk assessments where required
- Stay informed and communicate potential impact of regulatory developments and changes in Codes of Practice, regulations and compliance trends
- Coordinate and manage the transparency and aggregate spend activities required to meet EUROW / EFPIA reporting requirements, in collaboration with Sr. Manager, Transparency & Aggregate Spend
- Gather and remediate relevant spend data from all sources required to meet transparency obligations
- Work with Legal & Compliance colleagues to develop and implement regional monitoring and/or auditing plans
- Work with Sr. Director, Compliance Operations & Strategy to develop compliance metrics, identify trends, potential risks & remediation, and reports related to monitoring activities
- Assist in Code of Conduct annual certification process
- Liaising with appropriate staff about content of new or amended policies
- Assist with developing, writing and implementing SOPs in conjunction with other functional departments
- Assist Legal & Compliance Department personnel in developing and conducting Compliance training
- Coordinate and track Compliance training for our company, ensuring timely completion and appropriate documentation
- Advise the business on compliance matters, as required
- Provide compliance review and approval of engagements with HCPs, including FMV evaluation
- Work with Sr. Director, Compliance Operations & Strategy and Sr Corporate Counsel EU/RoW on completion of appropriate corrective actions, as necessary
- Assist in creation and delivery of compliance communications
- Collaborate with department colleagues to effectively deliver compliance program priorities and projects, as assignedQualifications:
- Bachelor degree in appropriate subject matter is required
- Minimum 2 years of compliance experience in a pharmaceutical, medical device or biotechnology company or handling compliance matters at a law firm or consulting firm
- Knowledge and understanding of transparency and aggregate spend processes and requirements
- The position requires the potential to develop and take on increased responsibility.
- Knowledge and understanding of healthcare compliance and the applicable legal and regulatory framework within the EU and member jurisdictions
- Knowledge of the Foreign Corrupt Practices Act and UK Bribery Act and their application in interactions between the pharmaceutical industry, healthcare professionals, healthcare institutions and other organisations.
- Experience in prioritising conflicting demands within the business
- Ability to work closely with individuals and groups to find solutions.
- Credibility to work and give advice across international regions, under the guidance of the Legal & Compliance leadership.
- Outstanding interpersonal skills and proven ability to communicate and work with all areas of the organisation, including field personnel
- Attention to detail and ability to analyse situations and find solutions
- Excellent verbal and written communication skills in English. Fluency in another language is an advantage.
- Ability to embrace and positively manage change
- Ability to travel regionally and internationally on an occasional basis is required
Oxford United Kingdom
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