More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!
The Associate Director, Compliance is accountable for managing the day-to-day compliance program for Takeda s USBU. It is responsible for embedding the elements of an effective compliance program throughout the commercial and medical organizations. Also responsible for analyzing and training USBU employees on state and federal laws relating to interactions with Health Care Professionals (HCPs). Working with the USBU Head of Compliance, this person is responsible for developing the overall strategic plan for compliance auditing and monitoring activities and providing leadership of related cross functional initiatives and activities while developing and sharing deep subject matter expertise. This position plays a key role in evaluating whether the company has policies covering the identified risk areas and that such policies were implemented, communicated and followed. The Associate Director, Compliance is responsible for proactively identifying issues, developing contingency plans, communicating issues to senior management and consistently managing issues to effective and appropriate resolution.
- Responsible for the strategic development of compliance policies and procedures for the USBU.
- Focus on strategies to embed the elements of an effective compliance program throughout the USBU, including field-based employees, in partnership with compliance colleagues and key stakeholders.
- Responsible for leading discussions with Commercial and Medical Affairs leadership to foster engagement and embedding of compliance within the business.
- Leads initiatives to support existing and create new ways to increase compliance awareness, visibility and engagement with field based resources
- Provide compliance guidance to managers and employees within departments including, but not limited to, Sales, Marketing and corporate functions and review needs assessments and strategic plans produced by these business functions.
- Develops strategies and tools for data analytics and monitoring.
- Anticipates changing industry regulatory climate and proactively aligns function goals and processes with current regulatory expectations. Interacts regularly with industry peers, co-marketing and co-promotion partners and vendors to shape direction and create systems which support industry-wide sample compliance activities.
- Engage in risk identification and assessment activities in partnership with the USBU Head of Compliance through activities including, but not limited to, performing prospective systemic reviews of applicable processes, protocols, and practices and/or retrospective reviews of actual practices in a particular area.
- Oversees development and training of new sales representatives on Takeda s Code of Conduct and Compliance Policies.
- Responsible for providing guidance to all USBU personnel who contact Compliance.
- Leads additional compliance initiatives that support the USBU as directed by the Head of Compliance USBU
- Oversees all facets of alliance partnerships for commercial organizations from an ethics and compliance perspective. These include co-promote and joint venture agreements. Responsibility for working in conjunction with their counterparts from these organizations to ensure compliance with state and federal health care program requirements.
- Oversees the day-to-day monitoring initiatives to ensure compliance with Takeda policies involving speaker programs, advisory boards, sample compliance, and other business activities that involve HCPs.
- Responsible for coordinating and developing materials for USBU Compliance Committee meetings including external benchmarking, internal compliance metrics dashboards, and compliance program vision.
- Responsible for providing USBU insights to the Global Compliance Operations Group for monitoring training and communications initiatives.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s Degree; MBA/JD/advanced degree a plus
- Pharmaceutical compliance experience with 5 years in a compliance related role is preferred.
- Minimum 7 years experience in the healthcare industry, a portion of which involves commercial and/or medical affairs corporate compliance experience
- Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, healthcare standard operating procedures, federal Sunshine Act, state disclosure laws, anti-bribery laws, and state price reporting statutes
- Experience leveraging monitoring and analytics to drive policy, processes, procedures and training
- Ability to communicate effectively with individuals up, down, and across the organization
- Strong leadership skills, including the ability to lead change efforts through effective communication and persuasion
- Solid understanding of state and federal health care laws/regulations
- Demonstrated project and program management skills. Experience in leading cross-functional projects and initiatives.
- Strong customer service skills and ability to interact with all levels of management, field sales, marketing, marketing and sales vendors and partners.
- Proactive, self-motivated, and able to work well in dynamic environment while consistently exercising good judgment.
- Able to work and deliver on deadlines while managing multiple projects and priorities effectively
- Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice
- Proficient Microsoft office products
- Seton Hall US Healthcare Compliance Certification Program a plus
- 25-40% overnight travel, mostly US travel but some international travel
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