The PositionThis role supports the Ethics & Compliance (E&C) strategy by assisting the Director, Government Accountability with daily operational activities related to government reporting obligations, such as all Federal and State Reporting Obligations and Risk Evaluation and Mitigation Strategy (REMS)including the management and oversight of systems supporting these processes. It involves coordinating and ensuring timely reporting of all government requirements and managing related documentation and systems. Additionally, the role includes tracking updates, participating in remediation activities and keeping E&C department leadership informed with regular status updates. The position will strongly focus on all Government Accountability functions including Federal and State Level Reporting and formal Project Management of all related processes Additional focus to include submission of all Transparency data to the CMS portal in a timely and accurate fashion using strong Project Management best practices.
RelationshipsReports to the Director, Government Accountability. Works closely with E&C colleagues across Novo Nordisk globally, NNI Legal team, Information Technology and other professionals throughout functionally related departments. External relationships include vendors, consultants, external customers including Health Care Professionals (HCP) as well as developing and maintaining relationships with the broader ethics and compliance network within the industry.
Essential Functions- Supports systems such as ITR and coordinating and ensuring timely reporting of all government requirements (e.g., federal and state reporting, REMS requirements)
- Manages the complete Project in relationship to all\a government reporting requirements both state and federal, ensuring accuracy and compliance
- Organizes department documents, manages all projects and tracks progress, primarily related to government and state reporting requirements
- Implements and oversees automation processes to improve data reviews and data quality for ensuring government obligations
- Tracks all policy and contract template updates as they relate to government reporting requirements. Informs the Director of significant changes and ensures the team is aware of and implements updates
- Along with the Director, Government Accountability, participates in remediation and corrective action activities, as needed including Lessons Learned and RACI of all tasks within the department
- Supports in creating, tracking and updating the annual government reporting plan as well as actual CMS submission and all State Reporting
- Prepares regular status updates for E&C department leadership in terms of reporting and process improvements
- Supports the Director, Government Accountability in raising awareness of the Compliance program and fostering accountability for compliance using process improvements to enhance overall compliance
- Leads project planning related to government reporting requirements including Federal Transparency and all State Reporting
- Ensures all government reporting reports are tracked and readily available upon request as well as assisting in documentation of all assumptions using strong project management skills
- Reviews budget for government reporting operational expenditures and projects
- Maintains an understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical compliance
- Handles additional responsibilities related to government reporting or departmental operational impact, as needed. Must be able to assist in data cleansing and loading in peak reporting times.
Physical Requirements0-10% overnight travel required.
Qualifications- A Bachelor's degree from an accredited institution is required
- A minimum of six (6 years of relevant work experience with Program Management experience in a corporate environment. Experience in pharmaceutical, healthcare, Information Technology, or medical device industry is Required. Privacy or compliance program experience is preferred
- Must have a general knowledge and understanding of pharmaceutical sales, marketing and/or product-related practices
- Must have a strong knowledge and understanding of pharmaceutical industry regulations and guidelines (e.g., PhRMA Code, Federal Anti-Kickback Statute and Spend Transparency)
- Preferred to have knowledge and understanding of Transparency related systems and technology used to facilitate the collecting, aggregation and reporting of information
- High standard of ethics and integrity
- Requires demonstrated experience in facilitating cross-functional teams
- Must have the ability to work under tight timelines with strong attention to detail
- Must display strong communication, planning, project management and organizational skills
- Experience in Project Management software and methodologies required
The base compensation range for this position is $120,300 to 222,600. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy and parental leave policy.