Risk Assessment and Monitoring Lead USBU at Takeda Pharmaceuticals America, Inc. in Lexington, Massachusetts

Job Description:

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Job Description

OBJECTIVES/PURPOSE

Ethics & Compliance (E&C) focuses on what the organization needs by ensuring

• Ethical behavior plays a fundamental role in risk mitigation


• Being a forward-thinking leader in risk identification and mitigation


• Building a modern function supporting achievement of Takeda’s Vision 2025

E&C will respond rapidly to changing environment and business needs, remain close to the market, and encourage ethical behavior in line with Takeda’s values. By working in an agile manner, E&C ensures the balance between stable structures, governance, processes and systems, and dynamic approaches to delivering innovative solutions to appropriately manage our risks.

E&C commits to

• Act as role model for Takeda's values, ethics and values-based decision making, fostering this mindset in clients, partners and team


• Enable the organization to take decisions which are ethical and in line with our priorities of Patient, Trust, Reputation, and Business


• Collaborate across all E&C teams and partner with stakeholders in BU / BF to embed ethics and compliance as part of the way everyone works at Takeda

RESPONSIBILITIES

• This position will lead E&C) efforts to establish, manage and enhance the Compliance Monitoring and Risk Assessment Programs for the USBU

• Rotate into lead and support roles within the Global E&C Monitoring program core team

• Lead global discussions relating to monitoring execution results, data collection and reporting, presentations, problem resolution, etc.


• Lead design and creation of the next evolution of USBU and Global reporting


• Lead improvements to the data submission and quality check process


• Collaborate on insights and analytics initiatives


• Develop Executive presentations to reflect Global and USBU Monitoring results

• Lead the USBU Risk Assessment program execution, enhancement, alignment with global, and report out to USBU executive staff


• Develop interview, survey, analysis, reporting, and presentation content to support the planning, execution, and finalization of USBU risk assessments


• Engage with Global E&C and Finance colleagues to shape the evolution of enterprise and local risk assessment programs


• Develop USBU-specific monitoring and analytics reports that identify potential non-compliant activities


• Communicate, prioritize and manage action plans resulting from monitoring findings and recommendations; ensure that all significant areas are appropriately documented and addressed


• Lead business groups’ understanding, processing, and implementing of remediation/corrective action plans that address monitoring findings or other audit finding


• Manage monitoring files and records, ensuring files are maintained in accordance with Record Retention schedules


• Develop and deploy general policies, procedures and processes to establish the USBU Compliance Monitoring Program


• Conduct research, represent Takeda at industry conferences, and consult with industry counterparts and E&C experts to continuously build upon the USBU E&C strategy


• Evolve the USBU monitoring program and collaborate on the global monitoring program


• Lead USBU risk assessments and audit governance initiatives
   

CAPABILITIES

• Ability to work with databases, data marts, reporting platforms, and financial systems


• Understands how to translate monitoring non-adherence into actionable process, policy, SOP, and/or system improvements


• Consistently demonstrates the ability to deliver results


• Able to work and deliver on deadlines while managing multiple projects and priorities effectively


• Works cross-functionally / collaborates / manages matrix


• Proven ability to work successfully with others and collaborate with cross functional areas to identify needs, provide guidance, and communicate solutions.


• Ability to rapidly assimilate to new functional scope responsibilities


• Strong customer service skills while interacting with all levels of management, field sales, marketing, medical, partners, and vendors. 


• Proven skills to transform ideas into conversations and materials that resonate (presentations, written documents, email, etc.).   


• Understanding of enterprise risks and enterprise risk assessment processes

EXPERIENCE

• At least six years of legal, compliance or commercial experience, of which at least 3 years in the healthcare or pharmaceutical industry;


• Bachelor’s degree required; JD or relevant advanced degree preferred 


• Solid understanding of state and federal health care laws/regulations


• 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, anti-bribery laws, and state price reporting statutes

Locations

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Full time