New Job Associate Manager - Government Accountability In New Jersey
Associate Manager - Government Accountability |
Associate Manager - Government Accountability
Company : Novo Nordisk
Salary : Details not provided
Location : New Jersey
Full Description
About the Department
At Novo Nordisk, we’re committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical & privacy standards and ensuring adherence to corporate and legal regulations, this team is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, ECP keeps us accountable every step of the way as we develop life-changing therapies and bring them to market. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Are you ready to make a difference?
This position is a Princeton, New Jersey Home Office based position. This position follows all NNI guidance for remote/in office dedicated time. EST time-zone hours.
The Position
The position is responsible for supporting the Ethics & Compliance (E&C) Department's Government Accountability Program (Program) objectives and obligations. This position supports Novo Nordisk's compliance with the Federal Physician Payments Sunshine Act (Sunshine Act or Open Payments), the Prescription Drug Marketing Act (PDMA), local/state sample obligations, Drug/Sharp takeback, pricing laws, and other state laws, by reviewing and analyzing data, developing project plans, and aiding in the submission of various government reports. This position also performs special projects and assists the execution of E&C deliverables throughout the organization as requested by E&C management.
Relationships
Reports to the Associate Director, Government Accountability. Regularly interacts with all other functional E&C areas and Line of Business (LoB) (e.g., Legal, Information Technology, Commercial Effectiveness, clinical Operations, and Marketing Effectiveness). The position will also interact with external customers including Healthcare professionals (HCPs), third party/external vendors/consultants. This position may interact with government officials as requested.
Essential Functions
- Supports the Associate Director, Government Accountability, in the execution of the E&C program, raising awareness of the program, and fostering accountability for Ethics & Compliance throughout the organization
- Collaborates with Ethics & Compliance, Legal, Human Resources, Field Sales, Customer Service, and third-party vendors to ensure compliance with state and federal laws and Company policies/procedures.
- Demonstrates knowledge and understanding of the Anti-Kickback Statute (AKS), the False Claims Act (FCA), FDA rules and regulations regarding the promotion of pharmaceutical products, government corporate integrity agreements and/or other prosecution agreements, federal and state transparency reporting requirements, local and state sample obligations, drug pricing laws, industry-specific guidance (e.g., PhRMA), etc.
- Supports various reporting government reporting obligations (e.g., Pricing, healthcare professional spend Transparency, Samples, etc.).
- Works within various transparency or other reporting systems/tools and analyzes data. Participates in User Acceptance Testing (when applicable).
- Supports source system (e.g., Concur, Veeva, etc.) owners in data collection and remediation activities
- Administers communications sent to the Sunshine Inquiry mailbox including: prompt tracking and response to inquiries, trending of inquiries and comments, and data retention.
- Develops responses to disputes/inquiries and resolves issues related to data submitted which require analysis or resubmissions. May manage Dispute/Inquiry proceses.
- Develops, implements, and monitors quality metric reports and provide trends and recommendations to improve data quality.
- Supports source system (e.g., Concur, Veeva, etc.) owners in data collection and remediation activities.
- Tracks and documents compliance activities.
- Prepares management summaries, project plans, monitoring and other ad-hoc reporting to support the Government Accountability Program.
- Collaborates with Government Accountability team members to identify areas for improvement in process, systems and policies.
- Develops and updates policies and training materials as needed.
- Informs management of ethics & compliance issues in a timely manner while encouraging the flow of information between colleagues and the organization.
- Identifies, analyzes, and mitigates potential business ethics and other risks to the organization.
- Executes on additional responsibilities with Government Accountability or departmental operational impact as requested.
Physical Requirements
0-10% overnight travel required.
Qualifications
- A Bachelors degree from an accredited institution required. Healthcare-related field (e.g. Biology, Pre-Law, Pre-Med, Business, Technology, Finance, etc. preferred)
- A minimum of 5 years combined pharmaceutical, legal, regulatory, and compliance experience required OR a minimum of 2 years’ experience required if accompanied by an advanced degree or certification (e.g. MBA, JD, PMP) (required)
- Knowledge of and experience in various pharmaceutical compliance with Anti-Kickback Statute (AKS), the False Claims Act (FCA), FDA rules and regulations regarding the promotion of pharmaceuticals, PhRMA, and federal and state aggregate spend reporting, PDMA, local and state sample obligations, and drug pricing laws. Understanding of government corporate integrity agreements and/or other prosecution agreements with other pharmaceutical companies. (strongly preferred)
- Experience with major aggregate spend disclosure systems/software and CMS Enterprise Portal. (strongly preferred)
- Excellent Microsoft Excel skills; intermediate use Microsoft PowerPoint and Word.
- Experience with data analysis and data visualization.
- Compliance training, auditing, and investigation experience preferred.
- Group leadership, project management experience.
- Detail-oriented, organized with strong problem-solving and critical thinking skills.
- Uncompromising ethics and high standard of personal integrity.
- Ability to communicate (verbal and written) effectively to technical and non-technical audiences.
- Ability to drive multiple projects to completion meeting internal and external deliverables with high degree of accuracy.
- Ability to manage multiple projects concurrently and collaborate across several functional areas.
- Ability to maintain confidentiality.
- Ability to work independently.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.