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Job Description

About the role:

Join Takeda as Senior Manager, Ethics & Compliance Operations, Oncology, where you will ensure ethical behavior, driving compliance and risk mitigation. You will oversee and execute day-to-day risk assessments, monitoring, training, and data analytics initiatives to identify and address potential compliance issues and ensure adherence to Takeda's policies and standard operating procedures. Your responsibilities will include developing Oncology Business Unit (OBU) specific monitoring protocols and processes, managing action plans from compliance risk assessments (CRA), preparing data-driven presentations, and collaborating with stakeholders to share actionable insights and drive meaningful results. You will lead operational components of the OBU Ethics & Compliance (E&C) programs, align monitoring efforts with global teams, and participate in global E&C projects and initiatives. As part of the Global Ethics & Compliance team, you will report to the Head of Ethics & Compliance Operations, Oncology and collaborate across E&C teams while partnering with business leaders and risk owners to support Takeda's compliance strategies and foster a “One-Country” operational approach.

How you will contribute:

• Oversee and execute the day-to-day risk assessment, monitoring & training initiatives to ensure compliance with Takeda policies and SOPs

• Communicate, prioritize and manage action plans resulting from monitoring findings, compliance risk assessment (CRA) and recommendations

• Interact with key business leaders or risk owners to drive monitoring, training or other OBU E&C operational initiatives forward

• Manage monitoring, CRA & training files and records, ensuring files are in accordance with Record Retention schedules, track and present findings

• Develop and deploy procedures and processes related to the OBU Monitoring

• Drive Compliance Risk Assessment and Global E&C Monitoring program and projects

• Drive operational elements of the OBU E&C program, in coordination with OBU E&C Partners team

• Drive development and implementation of compliance policies, SOPs & guidelines in OBU through direct interactions with relevant stakeholders

• Lead OBU E&C in relevant Global E&C projects and initiatives

• Lead alignment of monitoring efforts with Global OBU E&C and Global Monitoring teams

• Operate OBU E&C Operations on the basis of “One-Country” approach as needed.

• Determine and execute monitoring and data analytics requirements to support the identification of potential compliance issues and trends

• Develop OBU-specific monitoring protocols and reports that proactively identify potential non-compliant activities

• Prepare data analytics-related presentations; collaborate with stakeholders to determine needs and create methodology to share meaningful results

Minimum Requirements/Qualifications:

• 5+ years of legal, compliance, audit, or commercial experience, of which 2-3 years in the healthcare, medical device or pharmaceutical industry

• Bachelor's degree required

• Experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, PDMA, healthcare standard operating procedures, and anti-bribery and anti-kickback laws

• Experience executing compliance monitoring and training programs within the pharmaceutical or medical device