The Compliance Lead oversees compliance for NA and ELI markets, develops risk programs, manages compliance strategy, assesses risks, and oversees a team of compliance leads.
ROLE SUMMARY
• The NA and ELI Compliance Lead will serve as the primary compliance advisor to the Country Managers and their leadership teams, supporting a culture of quality and integrity and the assessment and mitigation of risks across all business units. The Compliance Lead drives the identification and effective management of key risk areas in collaboration with business leadership and local risk management functions, and provides oversight, strategic direction, and operational support for the implementation of all elements of an effective complia
ROLE RESPONSIBILITIES
Be the Compliance Leader:• Develops and drives NA and ELI compliance and risk program including through development of plan addressing the risk profile of the market. Overall, responsible for effective compliance program designed to prevent and detect systematic non-compliance and drive ownership of compliance.
Culture of Compliance: • Development of a comprehensive strategy and efficient operational approach to establish a culture of accountability and integrity to prevent systemic non-compliance in the NA and ELI markets and across the Cluster; Coordinate compliance-related communications, including updating business leadership on on-going environment and emerging risks, cultural challenges, significant compliance developments involving the business, and global compliance-related initiatives.
Governance: • Establish and engage in effective governance for strategic, comprehensive and optimized understanding and mitigation of risk in the cluster. Engage Risk functions at Cluster level to ensure strategic alignment on risk management plans• Engage Cluster Leadership to ensure effective risk-management governance, assessment and prioritization of quality and compliance risks, and design of effective mitigation in line with QMS elements. • Co-Chair NA and ELI Quality and Risk Committees (QRCs) with Country Managers to ensure effective risk-management governance, assessment and prioritization of quality and compliance risks, and design of effective mitigation in line with QMS elements.• Chair NA and ELI Risk Management Forums (mRMF) including all local risk management functions to ensure strategic, comprehensive, and optimized execution against integrated risk assessments, mitigation, and monitoring plans.• Represent Pfizer in key external forums such as Pharma associations and act as the internal point of contact/ coordination for pharma association related matters
Risk Assessment: • Identification, assessment and mitigation of risk, including from monitoring activities and investigation trends as well as regular coordination with key partners (e.g., Regional/Country Compliance Leads, Risk Assessment Office, Compliance Monitoring & Analytics); Guide the execution of annual risk assessments to support cluster and market risk prioritization; contribute to the development of a strategic direction for above-market Compliance mitigation activities based on the risk assessment results;• Lead the execution of annual risk assessments in NA and ELI markets to support local risk prioritization; contribute to the development of a strategic direction for above-market Compliance mitigation activities based on the risk assessment results. • Coordinate, lead, and/or support risk mitigation activities through strategic advice, policy/procedure support, training, communication campaigns, and monitoring in partnership with cross-functional risk management partners (e.g. BQ/MQO/CCRs) for priority risk areas.• Provide updates to the Compliance Division Leadership Team and other leadership and management forums on key risk areas and related mitigation and risk management strategies and efforts
Policies and Training: • Partner with relevant SMEs to identify policy and training needs and implement an effective policy and training framework for NA and ELI markets in consultation with key business and risk management partners.
Monitoring: • Identify monitoring needs in line with local risk assessment and cluster trends and coordinate or execute monitoring plans.
Corrective Action:• Collaborate with Investigations, Monitoring, Audit, and CCR teams to develop and implement interim corrective actions, implement agreed upon programmatic remediation and drive execution of remediation steps related to the Compliance Program.• Work with the Global Investigations group and, as appropriate, Government Litigation to manage and understand the docket of compliance investigations, communicate findings to Cluster leadership, and help manage closeouts and remediation efforts
Third Party Support:• Collaborate with necessary stakeholders to ensure the proper policies and oversight structures are in place to identify and mitigate risks related to third parties, including but not limited to BD transactions. • Support business development and third-party risk management as needed, with a focus on key partnerships (co-promotes/co-development) and supporting compliance integration for any acquired companies.
Global Compliance Division Priority Implementation: • Coordinate with appropriate stakeholders to implement key divisional priorities and support development and localization of global risk area solutions.
Management responsibilities • Oversee and manage a team of Country Compliance Leads within the Cluster, providing counsel and direction to ensure that all elements of effective risk management are in place across the countries/clusters in the region and ensuring that team members are effectively assessing risk management priorities in their respective markets and implementing impactful mitigation strategies.• Lead and grow team of Country Compliance Leads within the Cluster to further the Compliance Division's talent strategy• Serve as a member of relevant leadership teams and forums as may be assigned by the MERA Compliance Lead.
nce program.
QUALIFICATIONS • University degree in Law, Finance, Business, Medicine, or Science with strong academic background. • 10+ years professional experience in Compliance, Legal, Finance, Commercial, or Business Operations.• Understanding of the US FCPA, local regulatory environments (as relating to Compliance), relevant international and local Codes of Practice, guidelines, regulations as well as applicable Pfizer SOPs, Policies and Procedures.• Track record in developing meaningful solutions and appropriate controls for innovative business initiatives.• French, Arabic and English languages are a requirement
COMPETENCIES • High level proficiency in all the Pfizer CCL Capability Matrix' categories • Strong analytical, organizational, problem solving and strategic thinking skills; with ability to see the big picture as well as the detailed and specific relationships between business topics.• Ability to partner with key above market and in-market business leaders as an advisor and risk management partner. • Ability to encourage innovation and take appropriate risks to challenge the status quo.• Excellent written and oral communication skills in English; ability to summarize and articulate complex concepts clearly and efficiently.• Good working knowledge of requirements of local pharma Codes of Practice.• Ability to assess, understand and communicate risk profile and key healthcare compliance risk areas.• Strong communication skills to drive and message compliance culture as leader;• Ability to understand foreign cultures and sensibilities and to communicate effectively in a global environment.• Ability to prioritize time and resources. • Self-directed; ability to work both autonomously and as part of a team to resolve complex matters; and• Understanding of principles of escalation and independence.
• The role will provide subject matter expertise to support mitigation of the ABAC-related risk and MAPP related diligences and approvals.
• The NA and ELI Compliance Lead will partner closely with other global and regional functions within Compliance (e.g., Risk Assessment, Monitoring, ACPO, ICO) and outside Compliance (e.g., Legal, Medical, PX, Promotional Compliance, Corporate Affairs).
• The position reports to the MERA Compliance Lead
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Legal Affairs
• The NA and ELI Compliance Lead will serve as the primary compliance advisor to the Country Managers and their leadership teams, supporting a culture of quality and integrity and the assessment and mitigation of risks across all business units. The Compliance Lead drives the identification and effective management of key risk areas in collaboration with business leadership and local risk management functions, and provides oversight, strategic direction, and operational support for the implementation of all elements of an effective complia
ROLE RESPONSIBILITIES
Be the Compliance Leader:• Develops and drives NA and ELI compliance and risk program including through development of plan addressing the risk profile of the market. Overall, responsible for effective compliance program designed to prevent and detect systematic non-compliance and drive ownership of compliance.
Culture of Compliance: • Development of a comprehensive strategy and efficient operational approach to establish a culture of accountability and integrity to prevent systemic non-compliance in the NA and ELI markets and across the Cluster; Coordinate compliance-related communications, including updating business leadership on on-going environment and emerging risks, cultural challenges, significant compliance developments involving the business, and global compliance-related initiatives.
Governance: • Establish and engage in effective governance for strategic, comprehensive and optimized understanding and mitigation of risk in the cluster. Engage Risk functions at Cluster level to ensure strategic alignment on risk management plans• Engage Cluster Leadership to ensure effective risk-management governance, assessment and prioritization of quality and compliance risks, and design of effective mitigation in line with QMS elements. • Co-Chair NA and ELI Quality and Risk Committees (QRCs) with Country Managers to ensure effective risk-management governance, assessment and prioritization of quality and compliance risks, and design of effective mitigation in line with QMS elements.• Chair NA and ELI Risk Management Forums (mRMF) including all local risk management functions to ensure strategic, comprehensive, and optimized execution against integrated risk assessments, mitigation, and monitoring plans.• Represent Pfizer in key external forums such as Pharma associations and act as the internal point of contact/ coordination for pharma association related matters
Risk Assessment: • Identification, assessment and mitigation of risk, including from monitoring activities and investigation trends as well as regular coordination with key partners (e.g., Regional/Country Compliance Leads, Risk Assessment Office, Compliance Monitoring & Analytics); Guide the execution of annual risk assessments to support cluster and market risk prioritization; contribute to the development of a strategic direction for above-market Compliance mitigation activities based on the risk assessment results;• Lead the execution of annual risk assessments in NA and ELI markets to support local risk prioritization; contribute to the development of a strategic direction for above-market Compliance mitigation activities based on the risk assessment results. • Coordinate, lead, and/or support risk mitigation activities through strategic advice, policy/procedure support, training, communication campaigns, and monitoring in partnership with cross-functional risk management partners (e.g. BQ/MQO/CCRs) for priority risk areas.• Provide updates to the Compliance Division Leadership Team and other leadership and management forums on key risk areas and related mitigation and risk management strategies and efforts
Policies and Training: • Partner with relevant SMEs to identify policy and training needs and implement an effective policy and training framework for NA and ELI markets in consultation with key business and risk management partners.
Monitoring: • Identify monitoring needs in line with local risk assessment and cluster trends and coordinate or execute monitoring plans.
Corrective Action:• Collaborate with Investigations, Monitoring, Audit, and CCR teams to develop and implement interim corrective actions, implement agreed upon programmatic remediation and drive execution of remediation steps related to the Compliance Program.• Work with the Global Investigations group and, as appropriate, Government Litigation to manage and understand the docket of compliance investigations, communicate findings to Cluster leadership, and help manage closeouts and remediation efforts
Third Party Support:• Collaborate with necessary stakeholders to ensure the proper policies and oversight structures are in place to identify and mitigate risks related to third parties, including but not limited to BD transactions. • Support business development and third-party risk management as needed, with a focus on key partnerships (co-promotes/co-development) and supporting compliance integration for any acquired companies.
Global Compliance Division Priority Implementation: • Coordinate with appropriate stakeholders to implement key divisional priorities and support development and localization of global risk area solutions.
Management responsibilities • Oversee and manage a team of Country Compliance Leads within the Cluster, providing counsel and direction to ensure that all elements of effective risk management are in place across the countries/clusters in the region and ensuring that team members are effectively assessing risk management priorities in their respective markets and implementing impactful mitigation strategies.• Lead and grow team of Country Compliance Leads within the Cluster to further the Compliance Division's talent strategy• Serve as a member of relevant leadership teams and forums as may be assigned by the MERA Compliance Lead.
nce program.
QUALIFICATIONS • University degree in Law, Finance, Business, Medicine, or Science with strong academic background. • 10+ years professional experience in Compliance, Legal, Finance, Commercial, or Business Operations.• Understanding of the US FCPA, local regulatory environments (as relating to Compliance), relevant international and local Codes of Practice, guidelines, regulations as well as applicable Pfizer SOPs, Policies and Procedures.• Track record in developing meaningful solutions and appropriate controls for innovative business initiatives.• French, Arabic and English languages are a requirement
COMPETENCIES • High level proficiency in all the Pfizer CCL Capability Matrix' categories • Strong analytical, organizational, problem solving and strategic thinking skills; with ability to see the big picture as well as the detailed and specific relationships between business topics.• Ability to partner with key above market and in-market business leaders as an advisor and risk management partner. • Ability to encourage innovation and take appropriate risks to challenge the status quo.• Excellent written and oral communication skills in English; ability to summarize and articulate complex concepts clearly and efficiently.• Good working knowledge of requirements of local pharma Codes of Practice.• Ability to assess, understand and communicate risk profile and key healthcare compliance risk areas.• Strong communication skills to drive and message compliance culture as leader;• Ability to understand foreign cultures and sensibilities and to communicate effectively in a global environment.• Ability to prioritize time and resources. • Self-directed; ability to work both autonomously and as part of a team to resolve complex matters; and• Understanding of principles of escalation and independence.
• The role will provide subject matter expertise to support mitigation of the ABAC-related risk and MAPP related diligences and approvals.
• The NA and ELI Compliance Lead will partner closely with other global and regional functions within Compliance (e.g., Risk Assessment, Monitoring, ACPO, ICO) and outside Compliance (e.g., Legal, Medical, PX, Promotional Compliance, Corporate Affairs).
• The position reports to the MERA Compliance Lead
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Legal Affairs
Top Skills
Fcpa
Pfizer Sops
Pharma Codes Of Practice
Policies And Procedures
Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Manage people and resources, oversee operational activities, ensure quality compliance, and lead development within the department to improve processes.
Top Skills:
Laboratory Information Management SystemExcelMs Word
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The Customer Service Operations Specialist manages sales order processing, claims resolution, and digital transformation efforts to enhance customer service and operational efficiency.
Top Skills:
ErpSAP
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
The Customer Engagement Specialist builds strong relationships with customers, manages order-to-cash operations, analyzes customer feedback, and drives continuous improvements in service levels and customer satisfaction.
Top Skills:
Erp SystemsSAP
What you need to know about the Pune Tech Scene
Once a far-out concept, AI is now a tangible force reshaping industries and economies worldwide. While its adoption will automate some roles, AI has created more jobs than it has displaced, with an expected 97 million new roles to be created in the coming years. This is especially true in cities like Pune, which is emerging as a hub for companies eager to leverage this technology to develop solutions that simplify and improve lives in sectors such as education, healthcare, finance, e-commerce and more.