Lead, Monitoring, Transparency and Samples - Ethics and Compliance
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Lead, Monitoring, Transparency and Samples, Ethics and Compliance in our Lexington, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Lead, Monitoring, Transparency and Samples, Ethics and Compliance working on the US Business Unit Operations team, you will be empowered to embed ethics and compliance. In this role, you will contribute to Takeda s mission by acting as role model for Takeda's values, ethics and values-based decision-making. A typical day will include:
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, 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 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
- Act as the business owner of the Transparency system
- Program manage issues and system enhancement requests
- Develop a short, medium, and long-term system requirements roadmap that will support Federal and State disclosure as well as Compliance Reporting requirements
- Benchmark with external sources to evaluate Takeda strategy alignment with industry direction
- Develop business process, data taxonomy, and data collection designs and methods that will enable Takeda to support current and future Federal and State disclosure reporting requirements
- Prepare, confirm and submit all required State and Federal Reports (Compliance Program attestation, disclosure, etc.)
- Assist as a liaison between Ethics & Compliance and the Takeda legal group to creating policies, procedures, work instructions and other relevant material that supports Federal and State transparency and restriction requirements
- Develop acute knowledge of Federal and State laws that limit interactions with HCPs and HCEs. Create awareness and communications materials for Takeda business groups to access and answer any ad-hoc questions that arise.
- Assist in communicating transparency-initiative status, progress, and data analytics on an as-required basis to the executive compliance committees
- Collaborate with business groups on the delineation of responsibilities and protocols for managing non-compliance with data submissions
- Evolves the Sample Compliance program elements to match with FDA requirements as well as leading practice industry processes
- Develops collaborative relationships with the USBU Commercial Operations function that is responsible for Sample Operations scope
- Monitors and helps define sample compliance significant loss and lost in transit threshold methodology working with 3rd Party Vendors to revise as defined by Takeda policy
- Creates or revises sample compliance policies and procedures as required to either support ongoing business activities or to reflect changes in Ethics & Compliance or Legal positions concerning sample compliance business activities
- Continuously evaluates sample compliance tracking mechanisms, controls, documents, and systems for improvement opportunities. Implements changes where appropriate and in line with Ethics & Compliance directives.
- Determine and execute monitoring and data analytics requirements to support the identification of potential compliance issues
- Develops strategies and tools for data analytics and monitoring
- Leads the collaboration with USBU Ethics & Compliance and USBU business groups on monitoring remediation requirements, tracking and recommendations for updates to training, communications, policies and procedures
- Oversees the day-to-day monitoring initiatives to ensure compliance with Takeda policies involving speaker programs, advisory boards, sample compliance, and other business activities that involve HCPs, HCEs, and Patients
- Develop methods to share monitoring and analytics results with USBU business groups. Collaborate on improvement opportunities where relevant.
- Lead teams in a highly cross-functional environment
- Proactively engage with leaders in line-businesses to confirm roles and responsibilities and obtain buy-in on scope alignment
- Ability to design streamlined end-to-end processes
- Strong understand how to translate business objectives into system requirements and advocate for key decisions
- Ability to work with databases, data marts, reporting platforms, financial systems
- 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, marketing and sales vendors and partners.
- Proven skills to transform ideas into conversations and materials that resonate (presentations, written documents, email, etc.).
- Manage 3 direct reports and 1 indirect report.
- 5-8 years of relevant operations experience, of which at least 3 years in the healthcare or pharmaceutical industry;
- Experience managing business operations and/or workflow processes
- Exposure to laws and regulations relevant state reporting and aggregate spend as it relates to the pharmaceutical industry
- Bachelor s degree required
- 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
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- 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
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.