About the Department
At Novo Nordisk, we’re committed to building the best Compliance team in the pharmaceutical industry. Operating at the highest ethical standards and ensuring adherence to corporate and legal regulations, the Compliance 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, Compliance 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 responsible for supporting the daily operational activities related to the Ethics & Compliance (E&C) Department’s Government Accountability Program (“Program”). This position will be directly engaged with reviewing compliance with Federal PDMA obligations, local/state sample obligations, Drug/Sharp takeback compliance, and associated reporting. The position will also support other Programs as required. Additionally, this position will serve as the point of contact for E&C Department systems to interface with other Line of Business (“LoB”) systems, ensuring compliance objectives are met and coordination between them to ensure the Program’s effectiveness.
Reports to the Director – Government Accountability. Regularly interacts with all other functional E&C areas and LoB (e.g. Legal, Information Technology, Commercial Effectiveness, Clinical Operations, and Marketing Effectiveness). The position will also interact with external customers including Health Care Professionals (HCP), third party/external vendors, and external consultants. This position may interact with government officials. This position may manage employees in Novo Nordisk Inc (NNI’s) Global Servicing Center in Bangalore.
- Supports the Director – Government Accountability in facilitating and raising awareness of the Program while fostering accountability for E&C program throughout the organization
- Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical ethics & compliance and proposes updates to the Program, as appropriate
- Manages the review and timely reporting of all government requirements while understanding NNI, local and global impacts
- Responsible for creating and executing an Organizational Change Management (OCM) Plan for the Government Accountability programs
- Informs management of ethics & compliance issues in a timely manner while encouraging the flow of information between colleagues and LoB
- Actively works to identify, analyze, and mitigate potential business ethics and other risks to the organization
- Supports the Director with Business Assurance (BA) and Business Ethics & Compliance Office (BECO) collaborations regarding government requirements and integration of systems/data
- Supports NN affiliates (e.g., NNCI) with implementing and maintaining a government accountability program
- Recommends enhancements to systems, processes and technologies for government reporting
- Manages creation and continued maintenance of government accountability protocols and assumption documents to support accurate filings and internal documentation
- Conducts training to employees and third party vendors to timely communicate new government requirements or updated NN interpretations
- Supports the government accountability budget (e.g. forecasting expenditures, reporting variances, and ensuring responsible spending) as requested
- Maintains understanding of applicable laws and regulations, enforcement actions and evolving practices/trends relevant to pharmaceutical compliance
- Responsible for development of annual plan to strengthen NNI’s confidence when attesting to government reports (e.g., sample transparency, compliance program attestations). Support remediation and mitigation activities as they relate to Government Accountability Ensure that controls are in place for reporting completeness, consistency, accuracy, and integrity to strengthen and support the sub-certification/attestation process
- Responsible for ensuring that E&C senior management is informed of compliance issues in a timely manner
- Additional responsibilities with Government Accountability or departmental operational impact as assigned
0-10% overnight travel required.
- A Bachelor's degree from an accredited institution required
- A minimum of 8 years combined pharmaceutical, legal, regulatory, and compliance experiencerequired OR a minimum of 6 years' experiencerequired if accompanied by an advanced degree or certificate (e.g. MBA, JD, PMP)
- Demonstrates functional knowledge and understanding of the Anti-kickback Statute, the False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, government corporate integrity agreements, PhRMA and federal and state aggregate spend reporting requirements
- Knowledge and experience with pharmaceutical aggregate spend solutions and data associated with promotional and clinical data, preferred
- Experience working under a government agreement (e.g. CIA, DPA, Consent Decree) is required
- Demonstrates strong interpersonal skills and ability to influence at all levels of the organization
- Excellent communication and organization skills
- Excellent project management skills to oversee and drive project execution
- Ability to manage multiple projects concurrently and collaborate across several functional areas
- The ability to think objectively and use sound reasoning principles
- Ability to manage multiple projects to completion meeting internal and external deliverables with high degree of accuracy
- Excellent communication skills (written and verbal), strong report writing skills and organization skills are required
- Uncompromising ethics and high standard of personal integrity
- Ability to work proactively and independently with minimal supervision
- Proficiency in Microsoft Office Suite
- Supervisory experiencepreferred
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.
Requisition ID: 59041BR
Job Category: Legal & Compliance