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Job Description
Job Title: Ethics & Compliance Investigator
Location: Lexington, MA (Hybrid)
About the role:
You will will respond to changing environment and our needs, it is close to the market, and encourages ethical behavior following Takeda's values. By working in an agile manner E&C ensures the balance between stable structures, governance and processes, and dynamic approaches to delivering creative solutions to manage our risks. You will assess and manage concerns raised within the Global Manufacturing, Supply and Quality operations. As part of the Global Ethics & Compliance team, you will report to the Head of Ethics & Compliance Biologics and Onco ESSM.
How you will contribute:
You will assess allegations of misconduct, assign, conduct and document investigations of alleged violations of laws and regulations, Takeda's Global Code of Conduct, policies or SOPs, across the Global Manufacturing & Supply and Global Quality (GMSGQ) Operational Units including the manufacturing sites in the network and supporting above site functions.
Assess and manage the concerns reported and determine if an investigation is warranted.
Plan and run global and local impact investigations for a multinational, Japan / US listed pharmaceutical company.
Develop and execute an investigation plan and manage the work of internal/external resources involved in an investigation.
Support the GMSGQ Ethics & Compliance Team in their roles as the first contact for the relevant Departments and sites in the GMSGQ network on matters of concerns raised and investigated.
Where relevant, oversee or perform the execution of site investigations to ensure they are performed according to internationally recognized standards and Takeda's policies.
Partner with Human Resources, People Advisory Group, Global Ethics & Compliance and Legal departments on matters of investigations.
Identify, train and provide guidance to the GMSGQ E&C Advisors and other personnel in charge of conducting site investigations.
In coordination with the Global Ethics & Compliance Investigations team, provide regular reporting on the investigations to senior GMSGQ leadership, E&C leadership and key internal stakeholders.
Prepare GMSGQ Risks Ethics and Compliance Committee presentations relating to investigations trends, CAPA, case studies and insights.
Uses insights to effectively manage investigations in the company matrix model including across multiple stakeholders.
Interpret and contextualize rules, guidelines, procedures and controls.
Integrate data analytics tools and procedures as part of planning an investigation.
What you bring to Takeda:
7+ years of hands-on experience managing sensitive and complex investigations in the United States and internationally including cases of bribery, fraud corruption, harassment, conflicts of interest or similar.
Track-record in implementing corporate investigations for a multinational company.
Knowledge of the laws, regulations and industry codes relevant to the healthcare industry in the region and the applicable extraterritorial regulations (e.g., FCPA, SOX, False Claims Act, Antikickback Statute, Prescription Drug Marketing Act, etc.)
Experience with US and European pharmaceutical law, including fraud and abuse, anti-kickback and FCPA / UK Bribery matters.
Experience in helping with the development of corrective actions of risk areas/gaps identified during investigations.
Experience in managing virtual teams of external investigators in fieldwork and forensics.
Knowledge of other languages (e.g. Spanish, Portuguese, French) is preferred.
Compliance, Legal, audit or risk management background is preferred.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings.
Generous time off for vacation and the option to purchase additional vacation days.
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Flexible Ways of Working
Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
#GMSGQ #ZR1 #LI-MA1 #LI-Hybrid
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
