Job Details

Manager Compliance Operations

Company name

Novo Nordisk A/S.

Organization Type

In-House

Job Type

Non-practicing Attorney

Years of Experience

Min 5 yrs required

Location

Plainsboro, NJ

Date Last Verified

Apr 20,2018

Posted on

Mar 29,2018
Practice Area
Litigation >> Litigation - General/Commercial
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Manager Compliance Operations Job The candidate manages the execution and supports the development of the Ethics and Compliance Department Operations plan and manages strategic department areas within the Operations function (e.g. policies, third party representatives, special projects, etc.). This position also support and performs special projects aligned with the overall execution of the E&C strategy across functions/organizational lines as requested by E&C management. Reports to the Director, Government Reporting and Operations. Works closely with Ethics and Compliance Leadership (ECLT). Closely collaborates with company in-house legal counsel, leaders across lines of business, and is a member of cross-functional teams throughout NNI Supports affiliates (e.g. NNCI, NNRC) and Global Service Center in Bangalore. External relationships include vendors, outside counsel, industry peers, and government agencies. Supports the Director, Government Reporting and Operations in facilitating and raising awareness of the Ethics and Compliance program while fostering accountability for ethics and compliance throughout the organization. Maintains understanding of laws and regulations, enforcement actions and evolving practices relevant to pharmaceutical ethics and compliance and proposes updates to Ethics and Compliance program as appropriate. Establishes and maintains coordination with the global Business Ethics and Compliance Office (BECO) by supporting the Third Party Representative process (e.g., LDDR responsibilities) and Ineligible Persons review, including updating and maintenance of processes and procedures for identifying company employees, consultants, and vendors (i.e., Covered Persons, Ineligible Persons) while understanding local and global impact. Actively works to identify, analyze, and mitigate potential business ethics risks to the organization. Informs management of ethics and compliance issues in a timely manner, while encouraging the flow of information between colleagues and lines of business. Serves as the Quality Committee Representative and department contact for quality projects. Reviews department wide policies and procedures and obtains necessary feedback from SMEs to provide relevant updates to policy owners as they relate to the Ethics and Compliance Department. Responsible for the Third Party Representative process for the department (e.g. LDDR responsibilities) Responsible for Records Retention as related to government requirements. Monitors and updates Third Party Representative policy website Manages and monitors External Policy Place website. Plans and executes special projects in support of department initiatives Provides direction to the GSC Bangalore Compliance team. Provides support to the US affiliates (e.g. Seattle) and NNCI as needed Additional responsibilities with department or operational impact as assigned.

Qualification and Experience

A Bachelor's degree from an accredited institution required, additional education/certification within the compliance and healthcare related fields is preferred. 8 years combined pharmaceutical, legal, regulatory, and compliance experience required OR 6 years’ experience required if accompanied by an advanced degree or certification (e.g. MBA, JD, PMP). Experience working under a CIA is preferred. Should have demonstrated knowledge and understanding of the Anti-Kickback Statute, the False Claims Act, FDA rules and regulations regarding the promotion of pharmaceuticals, government corporate integrity agreements and/or other prosecution agreements with other pharmaceutical companies, PhRMA and federal and state aggregate spend reporting requirements required the current activities and developments involving pharmaceutical sales and marketing. Project management experience preferred.

Additional info

Requisition ID 55310BR

Company info

Hiring Coordinator
Novo Nordisk A/S.
800 Scudders Mill Road
Plainsboro, NJ 08536

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