The purpose of this position is to manage Takeda’s compliance with Federal and State transparency requirements as well as other ancillary areas such as restrictions on interactions with Health Care Practitioners (HCPs) or Health Care Entities (HCEs). This position will be responsible for understanding federal and state health care laws and regulations and ensuring that Takeda’s policies and procedures in these areas are developed and maintained to measure up to those standards. This position will work across the TPUSA as well as CMSO business functions and confirm that business groups are both aware of and in compliance with transparency policies and data collection requirements. This position is also responsible for managing the program as required to match changes in Takeda business practices as well as Takeda Legal and Compliance interpretation of Federal and State regulatory statutes, regulations, laws, and other relevant areas.
Aggregate Spend/Transparency System:
Manage, maintain and support the set of external Takeda suppliers who are designated as “HCP Suppliers” and as such are required to submit HCP related transactional and transaction detail to Takeda.
Determine the delineation between HCP relevant and non-relevant data within supplier and Takeda-internal submissions.
Manage all HCP validation protocols. This position will have the responsibility to maintain the set of supplier and Takeda-internal interactions that require validation and also the financial data against which data validation is required.
Oversee the creation and manage the distribution of supplier communications concerning missing data submissions, data submissions with errors, and data submissions requiring reconciliation. Follows-up as required with suppliers to resolve errors and complete the submissions process.
Act as an internal Takeda subject matter expert and maintain a detailed understanding of the end-to-end HCP spend-identification processes, associated spend collection processes and tools, and data reporting processes and tools.
Federal and State Reporting:
Oversee the development of methods that will enable Takeda to support current and future Federal and State disclosure reporting requirements
Responsible for the preparation, confirmation and submission of all required State and Federal Reports (Compliance Program attestation, disclosure, etc)
Federal and State Restrictions:
Responsible for understanding all current Federal and State laws that limit interactions with HCPs and HCEs. Create awareness and communications materials for Takeda business groups to access and answer any ad-hoc questions that arise.
Responsible for ensuring that Takeda’s policies and procedures surrounding federal and state reporting obligations meet or exceed the federal and/or state requirements.
Oversee the development of training materials for internal Takeda and external vendors that will support all Federal and State disclosure and restriction obligations.
Policies & Procedures
Responsible for periodically reviewing all of Takeda’s OEC policies and procedures to ensure they meet or exceed the various state and federal healthcare laws.
Benchmark with industry to ensure Takeda’s policies and procedures stay ahead of evolving laws, regulations and enforcement trends.
Collaborate with other functional areas within Takeda to ensure that their policies and procedures are aligned with state and federal healthcare laws . Qualifications
EDUCATION, EXPERIENCE, AND SKILLS:
8 years of relevant experience, with a minimum of 6 in the healthcare industry
In depth knowledge of laws and regulations relevant state reporting and aggregate spend as it relates to the pharmaceutical industry
Excellent oral and written skills
Experience drafting/reviewing policies an procedures for corporate compliance programs
Demonstrated project and program management skills. Experience in working in a cross-functional, multi organizational project or initiative.
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
JD or other advanced degree
Pharmaceutical compliance experience
Approximately 10% domestic travel is required
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 7 months ago