- Serves as the primary Integrity & Compliance point of contact and liaison to the Commercial and Medical functions and provides guidance on implementation of process, controls, and activities related to interactions with healthcare professionals (e.g., speaker programs, medical information requests, corporate sponsorships, medical education grants and investigator-initiated research).
- Interfaces and collaborates across the business with functions including Commercial, Medical, Market Access, Regulatory Affairs, Clinical Operations, Internal Audit, Legal, Human Resources, Finance and others as required.
- Delivers compliance training to new and existing employees in partnership with Integrity & Compliance operations (e.g., Commercial/Medical interactions, speaker program policy and Commercial / Area Reimbursement Manager interactions).
- Participates in the Management Compliance Committee and supports the Chief Compliance Officer in preparation for Board of Directors meetings.
- Supports our continuous improvement mindset for Mallinckrodt's compliance program by sharing business insights and examples of compliance-in-action with the Integrity & Compliance team, recommending program enhancements and leading the implementation of certain program updates.
- Provides guidance and oversight to ensure integration of appropriate policy into the development of programs, including oversight and/or review and approval of programs and processes with Commercial, Medical and other functions.
- Collaborates with Integrity & Compliance operations on healthcare professional engagement process, Corporate Integrity Agreement requirements, internal investigations, policy updates, exceptions approval and training.
- Follows up and assists with any necessary activity to ensure compliance with Company policy, laws, regulations, PhRMA and AdvaMed Codes and ACCME guidelines that impact the area under review.
- Partners with Integrity & Compliance operations on investigations and monitoring activities, including the implementation of corrective action.
- Follows and educates on our external regulatory landscape including OIG Guidance, corporate compliance program guidance, special fraud alerts, etc. and drives policy enhancements to align with our regulatory environment.
- Serves as a subject matter expert on healthcare compliance laws and regulations and contributes to compliance program monitoring activities (e.g., monitoring of speaker programs, Advisory Boards, ride alongs).
- BS/BA (or equivalent) from accredited university; MBA/JD/advanced degree preferred.
- 7+ years of pharmaceutical, healthcare or other compliance experience including compliance business partnership, monitoring, auditing or investigations.
- Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including OIG and PhRMA guidelines, healthcare standard operating procedures, Federal Sunshine Payments Act, state disclosure laws, anti-bribery laws and state price reporting statutes.
- Demonstrated knowledge of sales & marketing and medical policies and procedures in the pharmaceutical industry.
- Strong project and time management skills with the ability to handle multiple tasks, set priorities, meet deadlines, and develop process efficiencies where required.
- Able to work independently and know when to appropriately escalate an issue for resolution.
- Ability to communicate effectively through PowerPoint presentations, leading by influence, driving issues to resolution and thrive in a collaborative work environment.
- Demonstrated ability to communicate effectively with individuals up, down, and across the organization.
- Demonstrated leadership skills, including ability to lead change efforts through effective communication and persuasion.
- Overnight domestic travel as required (15-25%).
- This position will report to Mallinckrodt's Chief Compliance Officer.
- This position does not have direct reports.
- This individual will interact internally with senior executives, other individuals at all levels within Integrity & Compliance, cross functionally, and will also interact with external business partners.
Senior Director, Compliance Business Partner - Bridgewater Township, United States - Mallinckrodt Pharmaceuticals
Description
Description
Summary
The Senior Director, Compliance Business Partner for Specialty Brands serves as the primary point of contact and liaison between Mallinckrodt's business and our compliance program. This role is responsible for promoting awareness and compliance with Company policy, advising on business initiatives, strategic objectives, changes in our regulatory environment as well as day-to-day operational questions. Additionally, this role serves as the Integrity & Compliance subject matter expert and approver on various business-led committees including grants, promotional review and the specialty products enterprise committee. The Senior Director, Compliance Business Partner champions our company-wide culture of integrity and compliance and provides guidance to internal and external business partners including leading the Compliance Advisory Board and Compliance Champions programs. This position will report to Mallinckrodt's Chief Compliance Officer.
Essential Functions
Minimum Requirements
Organizational Relationship/Scope:
Working Conditions:
Typical office environment working conditions. Currently working in hybrid office schedule, 2 days in office, 3 days remote. This operating model could change based upon business needs.
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