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EMPLOYMENT OPPORTUNITIES

USBU ETHICS & COMPLIANCE BUSINESS PARTNER, PLASMA DERIVED THERAPIES - Takeda Pharmaceutical- Cambridge, MA US
SENIOR MANAGER HEALTHCARE COMPLIANCE - Immunocore- Conshohocken PA, Gaithersburg, MD US
ETHICS & COMPLIANCE BUSINESS PARTNER, U.S. ONCOLOGY BUSINESS UNIT - Takeda Pharmaceutical- Cambridge, MA US
SENIOR MANAGER, ETHICS & COMPLIANCE OPERATIONS, ONCOLOGY - Takeda Pharmaceutical- Cambridge, MA US
USBU ETHICS & COMPLIANCE BUSINESS PARTNER, PATIENT ACCESS & MARKET ACCESS - Takeda Pharmaceutical- Cambridge, MA US
HEAD OF ETHICS & COMPLIANCE PLASMA DERIVED THERAPIES R&D AND MEDICAL AFFAIRS - Takeda Pharmaceutical- Cambridge, MA & Chicago, IL US
COMPLIANCE OPERATIONS MANAGER - Mallinckrodt Pharmaceuticals- remote type - Hybrid Working. Locations: Webster Groves, MO and St. Louis, MO US

USBU ETHICS & COMPLIANCE BUSINESS PARTNER, PLASMA DERIVED THERAPIES - Takeda Pharmaceutical
Location: Cambridge, MA, US
Role: Hybrid

About the role:
Join Takeda as US Business Unit (USBU), Ethics & Compliance Business Partner, Plasma Derived Therapies (PDT) at the director level, where you will foster the ethical behaviors and Takeda Values that play a fundamental role in risk mitigation. For this role, the USBU Ethics & Compliance (E&C) team seeks a forward-thinking leader in risk identification and mitigation who wants to join an innovative function that responds rapidly to changing environments and business needs. By working in an agile manner, E&C supports stable structures, governance, processes and systems, while delivering innovative solutions that appropriately manage risks. As part of the USBU E&C team, you will report to the Head of Ethics & Compliance, Rare Disease, Plasma Derived Therapies & Patient Access and Market Access, and you will partner with the USBU's PDT Business Unit and related business functions to embed ethics and compliance as part of the way everyone works at Takeda.

How you will contribute:

Responds rapidly to changing environment and business needs, is close to the market, and encourages ethical behavior in line with Takeda's Values.
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 members.
Enables the organization to take ethical decisions in line with our priorities of Patient, Trust, Reputation, and Business
Collaborates across all E&C teams and partners with stakeholders in Business Units / Business Functions to embed ethics and compliance as part of the way everyone works at Takeda
Leads implementation of E&C strategy for the USBU's PDT BU by influencing senior management and other stakeholders to adhere to existing E&C principles and change behavior to new trends that Takeda establishes as best practice.
Maintains and further strengthens business expertise and nurtures cross functional relationships to enable a proactive, holistic and cross functional approach to risk identification.
Works closely with senior management and cross functional partners to align on, and implement, E&C controls to proactively manage identified risks.
Actively seeks opportunities to simplify and automate tasks and processes through the use of technology and digital tools, including AI and Agentic AI. Willing to experiment with digital innovation and to serve as a role model to colleagues on digital dexterity.
Develop programs that empower senior management as well as home office and field-based personnel to seamlessly integrate E&C principles and Takeda's Values into their day-to-day activities and leadership of others.
Provides E&C guidance related to company activities, such as organizational design, brand planning, needs assessments, and Incentive Compensation structures.
Anticipates the impact that guidance to one part of the organization could have on other areas of the USBU and proactively collaborates and communicates with the relevant stakeholders to manage this impact.
Demonstrates leadership within the USBU E&C organization, such as informally mentoring other team members and proactively educating other team members on relevant topics.
Provides leadership and guidance to senior management as well as home office and field-based personnel on interpretation of Code of Conduct, Compliance Policies, and relevant SOPs, guidance documents, and other E&C program requirements.
Delivers high-impact presentations to promote awareness and adherence to E&C principles and Takeda's Values (e.g., sales training).
Collaborates with E&C Operations in the creation and delivery of various E&C initiatives.
Collaborates with Digital E&C to support Takeda's digital and technology-driven initiatives.
Assists in developing materials for USBU Risk, Ethics and Compliance Committee (RECC) meetings including external benchmarking, internal compliance metrics - dashboards, and compliance program vision. Presents at RECC meetings where required.
Periodically reviews and adjusts policies and procedures to align with current Takeda Legal feedback as well as E&C team input.
Identifies and analyzes external trends and drives into organization where needed.
Performs periodic reviews of USBU E&C Policies and Procedures to ensure they are consistent with Takeda's Values, OIG regulatory guidance, PhRMA Code requirements and other applicable laws, regulations and internal policies and procedures
External facing - Drives USBU Business Partner engagement with evolving E&C trends (PhRMA, OIG, DOJ)
Negotiates to create solutions in harmony with leadership and business needs.
Partners with the business as well as any third-party vendor to live monitor USBU business unit activities, such as field rides, speaker programs and advisory boards.
Research and responds to compliance hotline/helpline questions on an as-needed basis.

Minimum Requirements/Qualifications:

Minimum of 8 years of Ethics & Compliance related experience; preferably with 5 years as part of the pharmaceutical, medical device or healthcare industries.
Bachelor's degree required; Juris Doctorate or relevant advanced degree preferred
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
Respected expert and advisor to senior management of the BU who influences and drives the Ethics & Compliance agenda for the BU
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
Works cross-functionally / collaborates / manages matrix - Strong leadership skills, including the ability to lead change efforts through effective communication and persuasion
Strong customer service skills and ability to demonstrate executive presence while interacting with all levels of management and stakeholders.
Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice
Must be willing to travel occasionally as needed

Preferred AI Capabilities & Experiences:

Effective data analysis and insights generation: The role requires strong capabilities in analyzing data and generating insights to support decision-making processes
Experience with AI and Collaborative Tools: Experience using AI assistants (e.g., Copilot within Microsoft Office tools and programs), collaboration platforms, and other tools to seamlessly integrate technology into daily operations. This includes leveraging AI for automating routine tasks, enhancing team collaboration, and improving overall productivity.
Storytelling with Data: The ability to effectively communicate complex data insights through compelling narratives. This skill helps in driving informed decision-making and fostering a data-driven culture within the organization.

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.

Apply here
Posted 10/20/2025

SENIOR MANAGER HEALTHCARE COMPLIANCE - Immunocore
Location: Conshohocken PA, Gaithersburg, MD US

Main Purpose of Job:
The primary purpose of this role is to leverage emerging expertise and subject matter knowledge in the field of healthcare compliance to address significant and unique complex issues, aligning work with the wider Immunocore's strategy. The individual will operate with the highest standards of integrity to help build a best-in-class compliance program.

As Senior Manager, Compliance Operations, you be a key part of Immunocore's compliance team and will serve as an in important business partner to other internal and external stakeholders to ensure that they can achieve strategic business objectives while adhering to all relevant legal, regulatory, and compliance guidelines to ensure global compliance at Immunocore.

The incumbent will be expected to understand how their role connects with the wider company strategy and contribute to functionally strategic decisions. Interactions with lower and senior management will be frequent, requiring the ability to persuade others in sensitive situations while preserving relationships.

Key Responsibilities:

Develop and maintain trusted partnerships and effective lines of communication across multiple business units, including commercial and medical organizations
Serve as a dedicated business partner to the field, including senior leadership.
Identify potential areas of compliance risk and develop plans to mitigate these risks.
Stay abreast of regulatory changes, emerging trends, and industry best practices.
Lead the collection, validation, and submission of transparency reports in accordance with US and International requirements.
Support comprehensive audits of internal processes and practices and live monitoring of business activities to ensure compliance with relevant US healthcare laws and regulations.
Monitor applicable and evolving regulatory requirements (e.g., OIG guidance, FCPA, GDPR, and state-specific laws) and assess their impact on business operations.
Create and maintain compliance policies and procedures.
Develop, implement, and manage compliance training programs for employees at all levels.
Conduct regular training sessions and provide guidance on compliance-related topics.
Monitor and track employee participation in training programs and ensure ongoing compliance education.
Investigate, document and propose solutions for compliance issues and concerns, executing recommendations as appropriate.
Assist investigations into potential compliance violations, implement corrective action plans, and ensure proper documentation and reporting.
Prepare and present compliance updates for Corporate Compliance Committee / senior leadership.

Education, Experience and Knowledge
Essential Qualifications:

Typically requires a Bachelor's degree and between 5 and 7 years+ of related experience in the Biotech / Pharma sectors
At least 3 years in the health care compliance/privacy sector

Preferred Qualifications:

Certification in healthcare compliance (e.g., CHC, CCEP) desired
Preferred Experience, Knowledge, Abilities
Ability to develop trusted partnerships, provide feedback clearly and succinctly maintain and effective lines of communication across the functional units in and out of the company, including the commercial and medical organizations.
Ability to conduct live trainings for various team members
Knowledge of healthcare privacy laws and obligations - US State and Federal Laws, HIPAA, GDPR, etc.
Knowledge of healthcare laws and regulations, including the False Claims Act, Anti-Kickback Statute, Sunshine Act and US State Transparency Laws, FDCA, FCPA/UKBA, etc.
Excellent analytical, organizational, and communication skills.
Ability to work independently and as part of a team to achieve compliance objectives.
Clear, concise, and persuasive verbal and written communication including presentation skills.

Other:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, telephones, photocopiers, filing cabinets etc.
25-35% travel required (Domestic or International)

IMMUNOCORE Values
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Apply here
Posted 10/16/2025

ETHICS & COMPLIANCE BUSINESS PARTNER, U.S. ONCOLOGY BUSINESS UNIT - Takeda Pharmaceutical
Location: Cambridge, MA, US
Role: Hybrid

About the role:
Are you looking for a patient-focused, innovative-driven company that will inspire you and empower you to shine? Join us as Business Partner, US Oncology Business Unit (US OBU) Ethics & Compliance at the Director level in our Cambridge, MA office. As the Business Partner, US OBU Ethics & Compliance, on the OBU Ethics & Compliance (E&C") team, you will be empowered to focus on what the US Oncology organization needs by ensuring ethical behavior plays a fundamental role in risk mitigation, being a forward-thinking leader in risk identification and mitigation, and building a modern function within Takeda.

How you will contribute:

Responds rapidly to the changing environment and business needs, is close to the market, and encourages ethical behavior in line with Takeda's values.
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 members.
Enables the organization to take decisions which are ethical and in line with our priorities of Patient, Trust, Reputation, and Business
Collaborates across all E&C teams and partners with stakeholders in Business Units / Business Functions across Oncology, and across Takeda, to embed ethics and compliance as part of the way everyone works at Takeda
Leads implementation of E&C strategy for identified US OBU business teams and functions by influencing senior management and other stakeholders to adhere to existing and evolving E&C principles and best practices.
Maintains and further strengthens business expertise and nurtures cross functional relationships to enable a proactive, holistic and cross functional approach to risk identification, assessment, and mitigation.
Works closely with senior management and cross functional partners to align on, and implement, E&C controls to proactively manage identified risks.
Develop and implements programs that empower senior management as well as home office and field-based personnel to seamlessly integrate E&C principles and Takeda Values into their day-to-day activities and leadership of others.
Provides leadership and guidance to senior management as well as home office and field-based personnel on interpretation of Code of Conduct, Compliance Policies, and relevant SOPs, guidance documents, and other E&C program requirements.
Provides E&C guidance related to company activities, such as organizational design, brand planning, needs assessments, and Incentive Compensation structures.
Anticipates the impact guidance within US OBU could have on other BU/BF within the US region, in particular USBU, and proactively collaborates and communicates with the relevant stakeholders to manage this impact.
Demonstrates leadership within the US OBU E&C organization, such as informally mentoring other team members and proactively educating other team members on relevant topics.
Delivers high-impact presentations to promote awareness and adherence to E&C principles and Takeda Values (e.g., sales training).
Collaborates with US OBU E&C Operations in the creation and delivery of various E&C initiatives.
Collaborates with OBU Digital E&C to support Takeda's digital and technology-driven initiatives.
Assists in developing materials for US OBU Risk, Ethics and Compliance Committee (RECC) meetings including external benchmarking, internal compliance metrics - dashboards, and compliance program vision. Presents at RECC meetings where required.
Periodically reviews and adjusts policies and procedures to align with current Takeda Legal feedback as well as E&C team input.
Identifies and analyzes external trends and drives into organization where needed.
Performs periodic reviews of US OBU E&C 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
External facing - Drives US OBU Business Partner engagement with evolving E&C trends (PhRMA, OIG, DOJ)
Negotiates to create solutions in harmony with leadership and business needs.
Partners with the business as well as any third-party vendor to live monitor US OBU business unit activities, such as field rides, speaker programs and advisory boards.
Research and responds to compliance hotline/helpline questions on an as-needed basis.

Minimum Requirements/Qualifications:

5+ years of relevant compliance, commercial, or pharmaceutical industry experience required.
Bachelor's degree required; JD or relevant advanced degree preferred
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
Up to 20% travel
Respected expert and advisor to senior management of the BU who influences and drives the Ethics & Compliance agenda for the BU
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
Works cross-functionally / collaborates / manages matrix - Strong leadership skills, including the ability to lead change efforts through effective communication and persuasion
Strong customer service skills and ability to demonstrate executive presence while interacting with all levels of management and stakeholders.
Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice.

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 based in Cambridge, MA and is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Apply here
Posted 10/14/2025

SENIOR MANAGER, ETHICS & COMPLIANCE OPERATIONS, ONCOLOGY - Takeda Pharmaceutical
Location: Cambridge, MA, US
Role: Hybrid

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 the 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 project
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 industry
Understanding of Ethics & Compliance, compliance monitoring and compliance risks
Exposure to and understanding of how to collaborate and advocate with global colleagues
Capability to lead and facilitate discussions with senior leaders within a business unit
Ability to work with analytics tools, databases, reporting platforms, and systems
Understanding of how to translate data into insights, actionable processes, policies, and/or system improvements
Able to work and deliver on deadlines while managing multiple projects and priorities
Proven ability to successfully collaborate with cross functional areas to identify needs, provide guidance, and communicate solutions
Flexibility to accommodate new projects and expanded functional scope responsibilities
Proficient in Microsoft Office applications, Sharepoint, LMS and PowerBI or Tableau

Apply here
Posted 10/13/2025

USBU ETHICS & COMPLIANCE BUSINESS PARTNER, PATIENT ACCESS & MARKET ACCESS - Takeda Pharmaceutical
Location: Cambridge, MA, US
Role: Hybrid

About the role:
Join Takeda as US Business Unit (USBU), Ethics & Compliance Business Partner, Patient Access & Market Access (PAMA) at the director level, where you will foster ethical behaviors and Takeda Values that play a fundamental role in risk mitigation. For this role, the USBU Ethics & Compliance (E&C) team seeks a forward-thinking leader in risk identification and mitigation who wants to join an innovative function that responds rapidly to changing environments and business needs. By working in an agile manner, E&C supports stable structures, governance, processes and systems, while delivering innovative solutions that appropriately manage risks. As part of the USBU E&C team, you will report to the Head of Ethics & Compliance, Rare Disease, Plasma Derived Therapies & PAMA, and you will partner with the USBU's PAMA organization, the team responsible for Takeda's patient support and market access initiatives, and related business functions to embed ethics and compliance as part of the way everyone works at Takeda.

How you will contribute:

Responds rapidly to changing environment and business needs, is close to the market, and encourages ethical behavior in line with Takeda's Values.
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 members.
Enables the organization to take ethical decisions in line with our priorities of Patient, Trust, Reputation, and Business
Collaborates across all E&C teams and partners with stakeholders in Business Units / Business Functions to embed ethics and compliance as part of the way everyone works at Takeda
Leads implementation of E&C strategy for the USBU PAMA organization and the CA&I team responsible for Takeda's patient initiatives by influencing senior management and other stakeholders to adhere to existing E&C principles and change behavior to new trends that Takeda establishes as best practice.
Maintains and further strengthens business expertise and nurtures cross functional relationships to enable a proactive, holistic and cross functional approach to risk identification.
Works closely with senior management and cross functional partners to align on, and implement, E&C controls to proactively manage identified risks.
Actively seeks opportunities to simplify and automate tasks and processes through the use of technology and digital tools, including AI and Agentic AI. Willing to experiment with digital innovation and to serve as a role model to colleagues on digital dexterity.
Develop programs that empower senior management as well as home office and field-based personnel to seamlessly integrate E&C principles and Takeda's Values into their day-to-day activities and leadership of others.
Provides E&C guidance related to company activities, such as organizational design, brand planning, needs assessments, and Incentive Compensation structures.
Anticipates the impact that guidance to one part of the organization could have on other areas of the USBU and proactively collaborates and communicates with the relevant stakeholders to manage this impact.
Demonstrates leadership within the USBU E&C organization, such as informally mentoring other team members and proactively educating other team members on relevant topics.
Provides leadership and guidance to senior management as well as home office and field-based personnel on interpretation of Code of Conduct, Compliance Policies, and relevant SOPs, guidance documents, and other E&C program requirements.
Delivers high-impact presentations to promote awareness and adherence to E&C principles and Takeda's Values (e.g., sales training).
Collaborates with E&C Operations in the creation and delivery of various E&C initiatives.
Collaborates with Digital E&C to support Takeda's digital and technology-driven initiatives.
Assists in developing materials for USBU Risk, Ethics and Compliance Committee (RECC) meetings including external benchmarking, internal compliance metrics - dashboards, and compliance program vision. Presents at RECC meetings were required.
Periodically reviews and adjusts policies and procedures to align with current Takeda Legal feedback as well as E&C team input.
Identifies and analyzes external trends and drives into organization where needed.
Performs periodic reviews of USBU E&C Policies and Procedures to ensure they are consistent with Takeda's Values, OIG regulatory guidance, PhRMA Code requirements and other applicable laws, regulations and internal policies and procedures
External facing - Drives USBU Business Partner engagement with evolving E&C trends (PhRMA, OIG, DOJ)
Negotiates to create solutions in harmony with leadership and business needs.
Partners with the business as well as any third-party vendor to live monitor USBU business unit activities, such as field rides, speaker programs and advisory boards.
Research and responds to compliance hotline/helpline questions on an as-needed basis

Minimum Requirements/Qualifications:

8+ years of Ethics & Compliance related experience, or 5 years of E&C and patient services or market access experience in the pharmaceutical, medical device or healthcare industries.
Bachelor's degree required; Juris Doctorate or relevant advanced degree preferred
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
Respected expert and advisor to senior management of the BU who influences and drives the Ethics & Compliance agenda for the BU
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
Works cross-functionally / collaborates / manages matrix - Strong leadership skills, including the ability to lead change efforts through effective communication and persuasion
Strong customer service skills and ability to demonstrate executive presence while interacting with all levels of management and stakeholders.
Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice

Travel Requirements:

Up to 20% travel

Preferred AI Capabilities & Experience:

Effective data analysis and insights generation: The role requires strong capabilities in analyzing data and generating insights to support decision-making processes
Experience with AI and Collaborative Tools: Experience using AI assistants (e.g., Copilot within Microsoft Office), collaboration platforms, and other tools to seamlessly integrate technology into daily operations. This includes leveraging AI for automating routine tasks, enhancing team collaboration, and improving overall productivity.
Storytelling with Data: The ability to effectively communicate complex data insights through compelling narratives. This skill helps in driving informed decision-making and fostering a data-driven culture within the organization.

Apply here
Posted 10/13/2025

HEAD OF ETHICS & COMPLIANCE PLASMA DERIVED THERAPIES R&D AND MEDICAL AFFAIRS - Takeda Pharmaceutical
Location: Cambridge, MA & Chicago, IL US
Role: Hybrid
Job ID: R0163874
Date posted: 10/08/2025

About the role:
The Head of Ethics & Compliance (E&C) for PDT R&D and Medical Affairs at the senior director level is a senior leader responsible for managing the E&C program across PDT R&D and Medical Affairs, and driving continuous improvement aligned with the strategic evolution of the business. Role modeling ethical behavior and embedding effective risk management into key business processes and conversations are critical success factors. In alignment with Takeda's values of Takeda-ism and the Patient-Trust-Reputation-Business (PTRB) decision-making model. Embedded in the business and a member of the PDT-R&D Extended and PDT E&C Leadership Teams, this role guides and directs senior leaders on all matters of ethics and compliance, shapes strategy, and fosters a culture of integrity. Key responsibilities include oversight of stakeholder interactions, clinical protocols, and medical plans; leading risk assessments and mitigation plans; overseeing investigations and audits; and delivering E&C training. The role also supports global initiatives, digital ethics, and data privacy efforts, while staying ahead of regulatory trends. Reporting to the Head of E&C for PDT, this leader collaborates across global E&C teams and PDT stakeholders to ensure the function remains agile, innovative, and aligned with Takeda's vision.

How you will contribute:

Accountable for the 8+1 Ethics and Compliance program for PDT R&D and PDT Medical Affairs.
Serves on the PDT-R&D Extended Leadership Team as a senior E&C leader with subject matter expertise on matters of risk, ethics and compliance.
Guides the PDT R&D leadership team through effective, risk-based decision-making, based on the regulatory environment, and the Takeda Values.
Supports the delivery of the E&C program, working closely with the PDT R&D Operations Team.
Strategically supports the E&C program across PDT BU.
Leads discussions with senior leaders and help shape the PDT BU's organizational mindset around Takeda's Values: Takeda-ism and PTRB (Patient-Trust-Reputation-Business)-Model to firmly embed values-based decision-making principles.
Serves as the PDT E&C R&D point of contact for the Global E&C R&D team and is actively involved in shaping the harmonization efforts with E&C Global R&D, and E&C USBU on common challenges and topics (approval processes, SOPs, FMVs,).
Reviews, assesses, and approves activities involving interactions with external stakeholders, clinical study protocols, and Medical Plans.
Leads the continuous updates to the E&C Risk Activity Assessment for PDT R&D, the Enterprise Risk Assessment (ERA) and the Compliance Risk Assessment (CRA) processes across PDT R&D and in close collaboration with other PDT E&C team members, including follow-up of assigned risk mitigation measures with the PDT R&D Leadership Team.
Oversees mitigation and remedial action from monitoring, audit, and case management.
Leads E&C investigations for PDT R&D. As needed, work in close alignment with the Global Investigations Team, with the HR team on disciplinary actions, and with Legal team on matters of legal interpretation/legal privilege.
Acts as point of contact for internal and external key stakeholders on matters related to the E&C PDT R&D priorities.
Designs and establishes relevant E&C policies and procedures across PDT R&D. Leads alignment of policies and procedures with other relevant E&C Leaders to drive consistency effectiveness.
Defines and delivers the E&C learning curriculum for PDT R&D, using the RITE learning model and in alignment with the overall PDT BU Learning Plan.
Ensures that the E&C Learning Curriculum is appropriately embedded in the annual learning offerings across the PDT R&D organization. Facilitates learning sessions across all aspects of the E&C program for PDT BU.
Uses the PDT BU Program Lifecycle Management (PLM) tool to assess current state of controls and relevant elements of the E&C program for PDT R&D on a regular basis.
Contributes to implementation of global E&C program projects, as relevant (Code of Conduct, Values initiatives, Policies and Procedures).
From time to time, leads global project teams on behalf of Global Ethics & Compliance, with direct impact on the Takeda company-wide E&C Program. Frequently takes the lead on PDT E&C projects, thereby indirectly leading the PDT E&C team on major programmatic enhancements with impact across PDT BU.
Responsible for horizon scanning related with evolving external E&C trends (US PhRMA, UK OIG, US DOJ, US SEC, US data privacy regulations) and subsequent alignment with the E&C program for PDT R&D.
Supports the Takeda Digital Ethics and Data Privacy Programs at PDT R&D working in close collaboration with the Head of Digital Ethics & Compliance, PDT BU

Minimum Requirements/Qualifications:

Minimum Bachelor's degree
Minimum 8 years of experience in the field of ethics and compliance in the pharmaceutical industry with a focus on Research and Development and Medical Affairs
Solid understanding and experience of Healthcare Compliance
Strong familiarity with and experience of all the elements of an ethics and compliance program (e.g. policies, risk management, learning, monitoring, case management)
Experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, IFPMA, EFPIA, OIG and PhRMA guidelines, healthcare standard operating procedures, and anti-bribery laws
Experience in managing potential, present and future compliance risks related to R&D and Medical Affairs activities including risk identification, controls & risk mitigation of potential non-compliance
Demonstrated project and change management skills
Experience of using Microsoft collaboration tools and other programs (e.g. Microsoft Office, Co-Pilot)
High interpersonal and communication skills including ability to challenge and provide advice/ guidance to business
Strong leadership skills, including the ability to lead change efforts through effective communication
Leading project teams and influencing with and without authority
Proven skills to transform ideas into conversations and materials that resonate
Effective data analysis and insights generation
Consistently demonstrates the ability to deliver results, at pace, and on time
Able to work and deliver on deadlines while managing multiple projects and priorities effectively
Ability to build strong relationships with key stakeholders and ability to demonstrate executive presence while interacting with all levels of management, individual collaborators and partners.
Demonstrated ability to identify, analyses, and interpret business and regulatory information and legal advice
Managing complexity and ambiguity: ability to develop and apply pragmatic solutions to complex legal, regulatory and industry issues
Mindset of curiosity, learning agility and interest in innovative ways of doing things.
Strong operations, process-orientation, data analytics, or technical expertise to effectively design, develop and implement compliance and relevant business processes, controls, and workflows

Preferred:

Effective data analysis and insights generation: The role requires strong capabilities in analyzing data and generating insights to support decision-making processes 1.
Experience of using co-Pilot within Microsoft Office tools and programs (e.g., Microsoft Office, Co-Pilot)
Experience with AI and Collaborative Tools: experience in utilizing AI bots, collaboration platforms, and other tools to seamlessly integrate AI into daily operations. This includes leveraging AI for automating routine tasks, enhancing team collaboration, and improving overall productivity.
Storytelling with Data: The ability to effectively communicate complex data insights through compelling narratives. This skill helps in driving informed decision-making and fostering a data-driven culture within the organization.

Apply here
Posted 10/13/2025

COMPLIANCE OPERATIONS MANAGER - Mallinckrodt Pharmaceuticals
Location: remote type - Hybrid Working - Webster Groves, MO US
Additional Locations: St. Louis, MO US
Time type: Full time
Job requisition: JR000015220 Compliance Operations Manager (Open)

Job Description
The Manager Compliance Operations is responsible for leading the development and execution of the department's compliance training program at both the strategic and tactical level. The Manager Compliance Operations is responsible for developing the annual training, communications plan, creating/updating communications, training materials and resources, with the assistance of applicable Corporate Compliance Business Partners, and conducting live and virtual training. The Manager Compliance Operations is also responsible for the management and updating of the compliance policy portfolio in coordination with Corporate Compliance Business Partners, Legal and business stakeholders.

Essential Functions

Compliance Training

Develop, implement and maintain Compliance Training Plan including development of role-based curricula, training assignment criteria, and training completion deadlines ensuring content is engaging, aligned with business needs, and accessible across roles and geographies.
Translate regulatory and policy requirements into clear, engaging, and actionable training content.
Partner with internal SMEs (e.g., Legal, Commercial) to ensure training is current, accurate, and aligned to business needs.
Coordinate development and review of compliance training materials; communicate training requirements to third-party vendor(s) supporting Compliance training activities.
Collaborate with company Learning Management System (LMS) Training team to design, develop, and deliver compliance training programs for field and corporate teams (live, virtual, and e-learning).
Communicate to business leadership timelines for training completion (as needed).
Engage and manage vendors hired to translate training materials into different languages as needed.
Monitor training effectiveness through assessments, feedback, and metrics to drive continuous improvement.
Support the development of onboarding programs and targeted refresher trainings for key functions and risk areas.

Compliance Policies, Procedures and Other Guidance Documents

Own and drive the lifecycle of compliance-related policies - from drafting and coordinating stakeholder review, to publishing, communicating, and tracking attestations
Collaborate with stakeholders to ensure policies are practical, well-communicated, and embedded into business processes
Oversee policy distribution and attestation processes, working closely with vendors or internal tools
Identify gaps in existing Compliance and other functional policies and procedures on ongoing basis.
Ensure periodic review of existing Compliance policies and procedures and manage needed updates and roll-out of updated policies and procedures, including training and certification.
Provide oversight of applicable other departmental policies and procedures
Manage and maintain Compliance Department policies and Frequently Asked Questions (FAQs) documents for functional support.
Collaborate with the Compliance Business Partners to provide guidance to business stakeholders on questions received about policies and procedures.

Compliance Communication

Drive, design and implement multi-channel communication plans to increase awareness and understanding of compliance priorities across the organization
Develop clear, professional, and engaging communications (email, intranet, newsletters, training promos) that reinforce key compliance topics and initiatives
Support compliance awareness campaigns, including Corporate Compliance & Ethics Week initiatives
Create PowerPoint slides, reports and other messaging for the Management Compliance Committee.
Assist in the maintenance of Compliance content on both the public website, as well as the Intranet page.
Raise awareness of the Compliance program and foster department and organization-wide accountability for compliance

Integrity & Compliance Program Administration

Support compliance team with operational services for the business
Oversee, monitor and support the Integrity & Compliance mailbox
Provide overall operations project management support for Compliance department.
Manage external vendors and consultants (e-learning developers, LMS providers, policy platforms) to support the creation of training, communication tools, and policy delivery systems
Proactively collaborate across departments to identify ways to improve areas of responsibility as well as suggestions to improve the overall Compliance Program.
Support execution of annual Risk Assessment
Support internal audits and monitoring by providing documentation related to training and policy execution
Implement tools or technologies that enhance compliance engagement, tracking and reporting

Minimum Requirements

Bachelor's degree in finance, life sciences or another healthcare-related field, more advanced degree is a plus
6+ years industry and compliance experience
Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including OIG, PhRMA and AdvaMed guidelines, Federal Sunshine Act, State disclosure laws, Anti-Kickback and anti-bribery laws, False Claims Act, and state price reporting statutes.
Strong working knowledge (intermediate to advanced skills) in Microsoft Office Applications, including Excel (e.g., formulas, pivot tables, v-lookups), Word and PowerPoint.
Strong project, time management, analytical and organizational skills with the ability to handle multiple tasks, set priorities, provide timely responses, meet deadlines, and develop process efficiencies where required
Able to prioritize and act with a sense of urgency when required
Able to work independently and know when to appropriately escalate an issue for resolution
Able to problem-solve (i.e., anticipate, initiate, and resolve issues)
Exhibits general business acumen
Excellent technical and communication skills
Excellent judgment and ability to handle highly confidential business matters in a fair and consistent manner
Strong relationship management, interpersonal skills and proven experience interacting with senior management
Previous compliance training experience, and policy management system implementation and general systems implementation experience a plus

Organizational Relationship/Scope:
Frequent communication and interaction with senior level management throughout organization.

Working Conditions:
Normal office setting. Position will require travel as needed. (<25%)

Pay Transparency:
The expected base pay range for this position is $125k-$155k. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.

This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion. Mallinckrodt Pharmaceuticals offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Benefits & Well-Being.

Apply here
Posted 9/30/2025

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