Overview

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 US Business Unit (USBU)
  • Develop and deploy general policies, procedures and processes to establish the USBU Compliance Monitoring Program
  • Develop annual desktop and live monitoring plans taking into account areas such as: risk assessment outputs, previous monitoring results, business activities, sample sizes, etc.
  • Conduct desktop and live monitoring on a quarterly basis and report summary and detailed results for USBU leadership review
  • Perform comprehensive root-cause analysis on non-adherence to controls
  • Lead business groups’ understanding, development, and implementation of remediation/corrective action plans that address monitoring findings or other audit findings
  • Communicate, prioritize and manage action plans resulting from monitoring findings and recommendations; ensure that all significant areas are appropriately documented and addressed
  • Enhance the program by developing analytics and reports that provide more real-time visibility to monitoring results
  • Support local and global vision to explore the capability for data, analytics and associated insights to transform the monitoring program and generate predictive as well as reactive results.
  • Provide leadership and individual contribution to Takeda’s  Global E&C Monitoring program
  • 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
  • Engage with Global E&C colleagues to shape the evolution of enterprise and local risk assessment programs
  • Lead USBU risk assessment and program execution,  including conducting interviews with senior business leaders, analyzing results, collaborating on risk mitigation planning and follow-up, and reporting outcomes to USBU executive staff
  • Manage monitoring files and records, ensuring files are maintained in accordance with Record Retention schedules
  • 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

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 risk management and 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, and anti-bribery laws.