Asc Dir Regulatory Comp

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This position will have responsibility for policy development, compliance management, and oversight and monitoring of Novartis Pharmaceutical Corporation (NPC)-wide activities, processes, and programs (e.g., sales, marketing, clinical, promotion review, managed care, grants). This individual plays a key role in raising the level of NPC's compliance with laws, regulations, guidance, industry standards, and NPC policies, thereby protecting Novartis and its employees.Key Responsibilities include:
1. Management of NPC-wide compliance with relevant State Laws (i.e., those within the scope of responsibility for Ethics & Compliance):
2. Lead role in reporting and analysis component of the Healthcare Professional/Organization total spend initiative (i.e., Aggregate Spend project):
3. Assist in the development of and take the lead in executing comprehensive and effective oversight and monitoring methodology, including report design, to manage and measure activities within the scope of responsibility for Ethics & Compliance (e.g., Promotional Review Process, Vendor HCP/O payment reconciliations, Grant Process, Clinical programs, etc.)
4. This individual will interface with various internal departments (e.g., Commercial Operations, Commercial Development, Legal, Regulatory, Medical Affairs, Brand, IT, Sales, Sales Operations, Finance, Oncology, Ophtha, TI&ID BUs), as well as external vendors (e.g., preferred suppliers, and consultants advertising agency, medical education, Apex application vendor(s)) in the formation of policy and process, delivery of training, and compliance monitoring and oversight.
5. Identify, document, and deliver appropriate standard and/or remedial compliance training and education to individuals and/or groups to reinforce and instill compliance with regulatory or Novartis policy/process guidelines.
6. Active participation in response to regulatory and other inquiries requiring timely response in areas within the scope of Ethics & Compliance responsibilities, as well as to assist other functional areas as warranted
7. This individual is expected to focus on continuous process improvement and capitalize on technology (e.g., systems, websites, etc.) in order to improve the efficiencies with which Ethics & Compliance achieves it goals.
8. Provide compliance advice as it relates to compliance with applicable rules, regulations and NPC policy.
9. Assist with, collaborate on, and/or lead ongoing and future Ethics & Compliance projects as assigned.Qualifications
1. Ten to twelve years experience, preferably in compliance-focused roles. Experience can include or be a combination of working in an auditing or monitoring role, management of compliance with regulatory requirements (e.g., promotional, PhRMA Code, OIG), within the pharmaceutical industry or in the capacity of a compliance-vendor.
2. Minimum requirement of BS or BA. An advance degree is a plus.
3. Ability to establish business partner relationships with internal and external associates, jointly developing compliance strategies and policies/processes and driving change management and implementation, while encouraging strong business results within a culture of compliance.
4. Strong policy, process, and technology expertise and has ability to apply specific category knowledge (e.g., auditing and monitoring, sales and marketing practices, R&D process) to compliance strategy and objectives.
5. Strong Communication skills. Strong verbal, presentation and written communication skills. Ability to communicate across all levels of the organization.6. Project Management. Ability to work in a fast-paced environment and manage complex projects and multiple projects simultaneously.
7. Functional Expertise. Financial and reporting tool expertise and skills.
8. Compliance subject matter expertise in one or more compliance-monitored program or activity areas or auditing and monitoring methodology, and working knowledge of the compliance function in the pharmaceutical environment.
9. Technology savvy preferred.
10. Pharmaceuticals experience strongly preferred; Other background will be considered if quantity and quality of other requirements are met.
11. Travel: 1 - 2 days per month.Preferred:

Extensive Compliance experience

Pharmaceutical Industry experience
Novartis is committed to embracing and leveraging diverse backgrounds.
Novartis is an equal opportunity employer M/F/D/V.