Associate Director, USBU Ethics & Compliance Advisory

Bio-Life Plasma, LLC

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Boston, MA

Job Description

As posted by the hiring company

Job Overview:

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Job Description

Associate Director, USBU Ethics & Compliance Advisory

Takeda Pharmaceutical

Cambridge, MA

About the role:

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as the Associate Director, USBU Ethics & Compliance Advisory in our Cambridge/Lexington, MA office.

As the Associate Director, USBU Ethics & Compliance Advisory working on the Ethics & Compliance team, reporting into the Head, USBU E&C, GIBU, Patient Services & Market Access, you will be empowered to advise respective franchises and cross-functional partners (e.g., Medical, Patient Services, Public Affairs, etc.) on risk mitigation, policy/SOP guidance, and ethical decision-making related to proposed or ongoing activities and strategic initiatives.

How you will contribute:

  • Ethics & Compliance (E&C) will respond rapidly to changing environment and business needs, it is close to the market, and encourages 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 a 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

  • Collaborate to create solutions in harmony with leadership and business needs

  • Lead initiatives to support existing, and create new ways to increase alignment with, Ethics & Compliance principles and Takeda Values through visibility and engagement with field based teams and other stakeholders

  • Lead, develop, and implement live training programs and strategies designed to support current and planned USBU business models

  • Review and assess fee-for-service engagement-related requests, including reviews of Commercial & Medical annual plans, needs assessments for all USBU activities/engagements (e.g., Advisory Boards, Speaker Bureaus, ad hoc consulting, etc.), and other fee-for-service requests

  • Review and assess other transfers of value (e.g., Grants, Donations, Sponsorships, etc.)

  • Review and assess non-promotional materials and provide ad hoc support to Promotional Review Teams on concepts and activities

  • Review and assess call plans, incentive compensation plans, and contests

  • Review and assess conflicts of interest in all aspects of the business

  • Participate in Annual Brand Plan Strategy sessions and review and assess presentations

  • Attend internal (e.g., POAs, NSMs, leadership meetings, etc.) and external (e.g., conferences, congresses, etc.) meetings and events to provide support and training on behalf of E&C function

  • Develop and deliver high-impact presentations (internal and external) to promote awareness and adherence to Ethics & Compliance principles

  • Develop materials for USBU Risk Ethics & Compliance Committee meetings including external benchmarking, internal compliance metrics, dashboards, and E&C Program vision. Present to USBU President and Executive Leadership Team at USBU Risk Ethics & Compliance Committee meetings where required

  • Conduct live monitoring (Speaker Programs, field rides, conferences, etc.) and support E&C Monitoring & Risk Assessment in development of risk assessment, sharing of monitoring results with BU/franchise leadership, and other monitoring efforts

  • Partner with E&C Monitoring & Risk Assessment team and business to support remediation and corrective actions related to monitoring findings and/or other non-compliant conduct

  • Support E&C Learning & Engagements team initiatives, including on maintenance of resource site and development of resources and training

  • Partner with and support E&C Investigations and Legal Litigation & Investigations teams on miscellaneous matters

  • Collaborate with other US and Global E&C teams on various matters to ensure alignment and/or to provide USBU perspective

  • Perform periodic reviews of US & USBU Policies and Procedures to ensure they are consistent with Takeda Values, OIG regulatory guidance, PhRMA Code requirements and other applicable laws, regulations and internal policies and procedures

Minimum Requirements/Qualifications:

  • 7+ years of legal, compliance or commercial experience, of which at least 5 years in the healthcare or pharmaceutical industry;

  • Bachelor's degree required

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

  • Extensive 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 statute

  • Ability to travel as needed (approx. 20%)

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 Work Paths

  • 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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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.


Boston, MA

Lexington, MA

Worker Type


Worker Sub-Type


Time Type

Full time