The Director will be responsible for strategic oversight and direction of the Health Care Compliance and Health Care Business Integrity (HCC/HCBI) program for Research and Development for the Pharmaceutical sector and Global Enterprise Innovation (GEI) teams (e.g., Innovation Centers, JLabs, JJDC) in Region (AsPac) and/or Therapeutic Area(s).
You will be a key interface to other Health Care Compliance Teams (including Regional Council, Operations, other sectors and Privacy) in the region. You will have overall responsibility for setting strategic direction and developing and managing a robust compliance program as well as adapting global strategies to meet the needs and risks of AsPac and Therapeutic area(s)/groups. You will serve as an internal compliance expert to senior leaders and key stakeholders on external programs, exercising judgment to mitigate business risk, and managing the allocation of resources to support business initiatives in AsPac and enterprise projects.
Major Duties & Responsibilities:
- Create and drive strategy and approach to HCC/HCBI Program(s) based on unique business models, activities and risk profiles R&D and GEI in the AsPAc region and/or Therapeutic Area(s).
- Responsible for building and maintaining an effective compliance program to ensure R&D & GEI business activities comply with HCC laws, regulations and industry standards related to interaction with health care professionals and/or government officials, including, as applicable to the business activities FCPA and other anti-corruption laws, off-label promotion, anti-kickback and false claims statutes and compliance with any applicable agreements or settlements.
- Collaborate with key business leaders to actively support new strategies, business models and growth strategies; advising on strategic changes required to meet compliance needs
- Engage with R&D Therapeutic or regional leaders and GEI by providing regular updates and partnering with key stakeholders to ensure governance and oversight of the compliance program to effectively prevent and/or detect violations of laws, regulations, or company policies.
- Serve as expert on risks and guidance specific to interaction with government officials, Patient Engagement, and third parties globally
- Serve as an engaged member of the R&D and Enterprise Innovation leadership team with responsibilities for providing updates on business, engaging in strategy development and leading key projects.
- In collaboration with HCC Operations, provide strategic direction and oversight of HCC/HCBI policies/procedures, education, training, and communications on HCC/HCBI requirements to all relevant employees.
- Partner with HCC Global Operations in developing and implementing the annual HCC testing & monitoring program commensurate with risk in the region/Therapeutic Area(s) and provide oversight of management action plans and corrective actions to close gaps identified during risk reviews, testing and monitoring.
- Interface with legal counsel regarding HCC requirements, legal interpretations, and issues that may be unique to region or businesses.
- Act as a consultant, adviser, and approver, as needed, for business activities involving HCC risks for region or Therapeutic Area/group(s).
- Influence the external environment in the region to help shape policies and industry standards.
- Respond to complaints and reports of potential misconduct through appropriate investigations and escalations, consistent with Company policies and procedures.
- Advise HCC Senior Management and business stakeholders of potential compliance risks, compliance related incidents and investigations, trends, root causes, and recommend and implement appropriate action plans.
- Develop High functioning team through talent and skill development, recruiting, training and coaching of team members
- Provide direction and oversight on the coordination of tasks, resources, and priorities across the team of direct & indirect reports
Required Minimum Education: BA/BS required
Required Years of Related Experience:
- 8-10 years of business experience including a minimum of 5 years’ experience and demonstrated leadership in HCC or related compliance function (HCC, Regulatory, Quality, Finance) required
- Experience working in region (AsPac, preferred) outside US in HCC or related compliance function is required
Required Knowledge, Skills and Abilities:
- Demonstrated experience in the development and implementation of a compliance program in accordance with an organization's risk profile is required.
- Strong knowledge of international, federal and local HCC fraud and abuse laws; FDA regulatory promotional practices; anti-bribery/anti-corruption laws (such as FCPA), Industry Codes, state requirements, financial or auditing practices and other relevant and applicable company policies is required.
- Ability to lead project teams across multiple business units and functions
- Proven track record interacting with senior executives and ability to influence senior leaders, as well as other levels within an organization is required
- Broad business experience and a proven ability to collaborate across all levels of the organization, negotiate and influence business decisions, and work towards solutions to drive compliant growth
- Ability to advise senior leaders and key stakeholders on business initiatives or complex compliance issues
- Aptitude for managing through ambiguity and creating solutions
- Strong leadership and interpersonal skills
- Strong written and verbal communication skills, organizational skills, program management sills, and analytical/process skills
- Proven track record as a self-starter with ability to manage complexity