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E&C Advisor, Plasma-Derived Therapies R&D and Strategy

Boston, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

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E&C Advisor, Plasma-Derived Therapies R&D and Strategy

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Job ID R0020508 Date posted 07/01/2020 Location Boston, Massachusetts

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Job Description

OBJECTIVES/PURPOSE

Ethics & Compliance (E&C) focuses on what the organization needs by partnering closely with the business stakeholders to help create, support and enable an embedded ethics and compliance framework. We do this by

  • Ensuring that our valuesare at the core of business conduct och underpin individual behaviours and decisions to effectively manage corporate risks
  • Being a forward-thinking leader who anticipates the impact that changing regulations and public debate on topics of ethics will have on the business
  • Taking a modern approach to the E&C operating model by establishing and maintaining a functional structure and agile framework, supporting the achievement of Takeda’s Vision 2025 and the E&C strategy.

E&C will respond rapidly to changing environment and business needs, it is close to the market, and encourages and help enable ethical behaviour 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 risks.

E&C commits to

  • Act as role model for Takeda's values and foster an ethics and values-based decision making mindset in internal clients, partners and team
  • Enable the organization to make ethical decisions in line with our priorities of Patient, Trust, Reputation, and Business
  • Collaborate across all E&C teams and partner with stakeholders in BUs / BFs and LOCs to embed ethics and compliance as part of the inherent way of work at Takeda

RESPONSIBILITIES

  • Lead implementation of E&C strategy for PDT R&D and PDT Strategy by influencing senior management and other stakeholders to adhere to existing ethics & compliance principles and change behavior to new trends that Takeda establishes as best practice.
  • Works closely with senior leaders and cross functional partners to align on, and implement, E&C controls to proactively manage identified risks. A high level of collaboration and interaction with the regions, LOC’s and Global BUs/BFs will be a natural part of the role. Alignment with USBU, Global R&D, OBU and PVPS for US country-based activities and policies is fundamental.
  • The PDT R&D function will include not just clinical development of plasma derived products but also medical devices supporting patients and physicians in treatment. The E&C Advisor will partner with the PDT R&D team and PVPS to understand the marketing strategy and ensure that risks associated with global deployment of devices are addressed at the earliest stages.
  • PDT R&D will engage with HCP’s in a variety of ways. The E&C Advisor will provide advice and guidance on engagements to ensure compliance with laws and regulations and alignment with the Takeda ethical values and priorities. Close alignment and transparent communication with the USBU and the Global R&D E&C teams is required to ensure effective internal controls are in place to manage risk and drive efficiency in decision-making.
  • The PDT Strategy group works pro-actively with external and internal parties to find and enable new opportunities for expanding aspects of the PDT business, ranging from expansion of plasma donation capacity to manufacturing and fractionation capacity. The E&C Advisor will provide strategic advice to PDT R&D and PDT Strategy, including external partnership, engagement, and clinical development activities. The role holder will lead Due Diligence on Ethics & Compliance matters for all strategic business development opportunities and make decisions about risk exposure and alignment with the Takeda values and priorities.
  • Standard compliance program responsibilities including defining the parameters for HCP interactions, patient interactions, FMV, policy development, monitoring, risk assessments and training will be part of the key responsibilities of this position. As the PDT R&D function is growing its activity base, the E&C Advisor will drive the establishment of all components of the E&C framework.
  • The E&C Advisor is a member of and active contributor to the PDT R&D Leadership Team and works closely with the Head of PDT Strategy and team. The role holder will partner with these teams to champion and shape the organizational mindset around our values of Takeda-ism and to embed ethical decision making principles. It is also expected to work and closely align with the E&C Global R&D and and US BU teams.
  • The E&C Advisor, PDT R&D & PDT Strategy works closely with the Head E&C, PDT and the E&C Advisor, PDT BioLife to ensure effective design of and efficient execution of E&C PDT KPIs and contributes to the overall E&C PDT outcome and deliverables.
  • The role holder will represent E&C PDT on global E&C and cross-functional projects and provide input to global E&C Policies/SOPs, initiatives or programs as relevant and interface with other E&C teams
  • Ensure understanding of overall PDT strategy, business model, R&D and Business Development pipeline for efficient support. Identify and evaluate emerging industry trends and laws/regulations and communicate potential impact to the business accordingly
  • The E&C Advisor will drive capability building for PDT R&D and PDT Strategy teams of risks, values, and ethical considerations for decision-making.

CAPABILITIES

  • Respected senior expert and advisor to the senior leadership team of PDT R&D and PDT Strategy who influences and drives the Ethics & Compliance agenda for the BU
  • Uses broad understanding of the current and future business and the industry to champion and create solutions that better serve the BU
  • Uses a holistic view of the business and diverse perspectives beyond own role to find opportunities to adopt more effective ways of working
  • Strong leadership skills, including the ability to lead change efforts through effective communication and persuasion, with very strong influencing skills without explicit authority or accountability
  • Effective people manager who invests time in developing capabilities for individuals, teams and across the organization
  • Defines effective, risk-based governance models of key E&C elements for PDT BU that reduces complexity
  • Works cross-functionally, collaborates, ability to effectively interface with a matrixed organization
  • Exceptional skills to transform ideas into conversations and materials that resonate (presentations, written documents, email, etc.)
  • Consistently demonstrates the ability to deliver results both through self and others 
  • Able to work and deliver on deadlines while managing multiple projects and priorities effectively 
  • Learning agility – appetite for continuous self-learning and development through new challenges
  • Self-starter and ability to work independently with very strong network-building capability
  • Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice

EXPERIENCE

  • 10-14 years Pharma/Healthcare experience with at least 8 of those in Ethics & Compliance related roles
  • Background in either healthcare compliance or other regulatory areas
  • Knowledge of Pharmaceutical and/or device development
  • Bachelor’s degree required; relevant advanced degree preferred 
  • Experience in aligning potential, present and future compliance risks related to the business, including risk identification, controls & risk mitigation of potential non-compliance
  • Senior expert in E&C matters with proven responsibility to define and align E&C strategy with the business. Successfully embedded an effective and efficient E&C framework into business units
  • Proven leadership of global, strategic programs requiring extensive cross-functional engagement and management of multiple diverse teams
  • 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, regulations governing medical devices, anti-bribery laws, and state price reporting statute
  • Significant advisory experience in customer facing roles
  • Defined the overall learning approach for E&C topics aligned with business needs.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0020508

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