Tevapharm
Director, Compliance & Ethics, Global R&D and Medical Affairs
Tevapharm, Parsippany, New Jersey, us, 07054
Director, Compliance & Ethics, Global R&D and Medical Affairs
Date: Sep 6, 2024Location: Parsippany, United States, New Jersey, 07054Job Id: 58137Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.The opportunity
The Director Compliance & Ethics, Global R&D and Medical Affairs reports to the Global R&D Compliance Officer, with a dotted line reporting to the Sr Director of NA Compliance. This role serves as the primary compliance officer for US Medical Affairs as well as some functions within Global Medical Affairs, and also provides compliance support to R&D functions (including Global Medical Affairs, Global Pharmacovigilance, and Global Health Economics and Outcomes Research) based inside and outside of the US. This role will leverage in-depth expertise and knowledge of the industry’s legal/regulatory environment in order to provide clear, concise and pragmatic policy and procedure guidance to these teams. This role will also be responsible for monitoring Global R&D and GMA business activities and programs to ensure compliance with regional/country specific laws and regulations and company policies and procedures.The Director will collaborate with regional and local Legal and Compliance colleagues to ensure that Teva activities and programs are implemented in a manner that accounts for local laws and acceptable industry practices and are aligned with and supported by regional and local management. The Dir will maintain appropriate independence and objectivity in order to provide an assessment of potential risk faced by the organization to the Global Compliance and Ethics leadership. This position requires the ability to work independently and communicate effectively with Global Compliance & Ethics colleagues and other business partners, and to lead project teams.Location:
This is a hybrid role (3 days/week in office) that can be based in either our Parsippany, NJ or West Chester, PA office.How you’ll spend your day
Provides clear, concise and practical policy and procedure guidance to Global R&D and GMA functions to prevent illegal, unethical, or improper conduct. Ensures appropriate compliance controls are embedded, maintained, and followed in the Global R&D Compliance & Ethics Policy, the US Commercial Compliance & Ethics Policy and supporting SOPs, as well relevant functional area procedural documents in R&D and GMA. Analyzes and synthesizes external enforcement trends for the business in order to inform risk-based decision making.Responsible for reviewing and coordinating approvals of R&D and GMA activities and programs in accordance with global/regional/country specific laws, regulations and company policies and procedures.
Manages the GC&E review and approval process to ensure interactions with and payments to HCPs, Government Officials, and other members of the healthcare community comply with company policies.Provides guidance to R&D and GMA organizations/functions to ensure proposed activities are in compliance with Teva Policies, functional and local SOP’s and adhere to applicable healthcare laws and regulations.Supports the identification, development and delivering of communications and training for internal and external partners to reinforce and instill compliance with the policies and processes related to R&D and GMA activities.Collaborates with Regional and Local Compliance colleagues, to ensure activities at the country and regional level are conducted in accordance with local laws as well as Company standards of conduct and industry best practices.Monitors approved EngageMate activities to ensure that (1) all required post-activity documentation is uploaded so that activities can be closed in a timely manner, and (2) information is provided to enable Teva to comply with transparency reporting obligations.Participates in cross-functional teams designed to ensure the effective/compliant implementation of programs and activities, including, but not limited to, the Global Compliance & Ethics teams responsible for EngageMate, transparency reporting, fair market value, monitoring, third party due diligence and data privacy systems.
Develops and implements compliance risk assessments and monitoring programs of activities and programs conducted by Global R&D and GMA and provides guidance to the functions on remediation actions needed.Any other duties or assignments as requested by the Global R&D Compliance & Ethics Officer and/or the Sr Director of NA Compliance & Ethics.Your experience and qualifications
A Bachelor’s Degree (BS/BA) is required. Advanced degree (Masters’ Degree or Juris Doctorate) is preferred.Minimum 8 years’ experience, preferably in healthcare environment and the pharmaceutical industry, with minimum of 3 years in compliance/risk related role.International experience.Experience in commercial, Medical Affairs and R&D functions.Strong project management skills with oversight experience in both internal and external projects.Strong interpersonal skills with demonstrated ability in participating and leading cross-functional teams, excellent skills in leading without authority and managing through influence.Pharmaceutical leadership, including experience in strategy development and interaction with business partners and third parties.Policy and procedure creation and implementation.Must have strong healthcare industry, including knowledge and experience working with Operations, Sales, Marketing, Legal, HR, and Regulatory.Experience in third party oversight.Ability to successfully partner with multiple business units and influencing others at all levels of the organization.Ability to take on large projects involving multiple stakeholders, multi-task, work independently and problem solve.Strong written/verbal communication skills -- ability to develop and deliver compelling presentations.Ability to think strategically and tackle complex problems.Ability to influence and impact without direct authority and develop strategic partnerships across functions.Strong executive presence and ability to interact effectively with all levels of the organization.Demonstrate intellectual curiosity and ability to identify trends/patterns.Ability to identify, advise on, minimize business risks, and propose practical solutions.Strong customer-orientation; an ability to see issues from the point of view of others.Ability to work successfully and cooperatively with colleagues across multiple cultures and time-zones.Knowledge of industry codes (PhRMA, EFPIA, IFPMA, ABPI), Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers, Anti-kickback Statute and False Claims Act and related enforcement actions.Knowledge of Foreign Corrupt Practices Act and UK Bribery Act.Knowledge of international regulatory requirements, including Good Clinical Practice, Human Research Protections, Declaration of Helsinki.TRAVEL REQUIREMENTS
Business travel will be required for some projects (approximately 20%).Enjoy a more rewarding choice
We offer a competitive benefits package, including:Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.Life and Disability Protection: Company paid Life and Disability insurance.Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible, Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
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Date: Sep 6, 2024Location: Parsippany, United States, New Jersey, 07054Job Id: 58137Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.The opportunity
The Director Compliance & Ethics, Global R&D and Medical Affairs reports to the Global R&D Compliance Officer, with a dotted line reporting to the Sr Director of NA Compliance. This role serves as the primary compliance officer for US Medical Affairs as well as some functions within Global Medical Affairs, and also provides compliance support to R&D functions (including Global Medical Affairs, Global Pharmacovigilance, and Global Health Economics and Outcomes Research) based inside and outside of the US. This role will leverage in-depth expertise and knowledge of the industry’s legal/regulatory environment in order to provide clear, concise and pragmatic policy and procedure guidance to these teams. This role will also be responsible for monitoring Global R&D and GMA business activities and programs to ensure compliance with regional/country specific laws and regulations and company policies and procedures.The Director will collaborate with regional and local Legal and Compliance colleagues to ensure that Teva activities and programs are implemented in a manner that accounts for local laws and acceptable industry practices and are aligned with and supported by regional and local management. The Dir will maintain appropriate independence and objectivity in order to provide an assessment of potential risk faced by the organization to the Global Compliance and Ethics leadership. This position requires the ability to work independently and communicate effectively with Global Compliance & Ethics colleagues and other business partners, and to lead project teams.Location:
This is a hybrid role (3 days/week in office) that can be based in either our Parsippany, NJ or West Chester, PA office.How you’ll spend your day
Provides clear, concise and practical policy and procedure guidance to Global R&D and GMA functions to prevent illegal, unethical, or improper conduct. Ensures appropriate compliance controls are embedded, maintained, and followed in the Global R&D Compliance & Ethics Policy, the US Commercial Compliance & Ethics Policy and supporting SOPs, as well relevant functional area procedural documents in R&D and GMA. Analyzes and synthesizes external enforcement trends for the business in order to inform risk-based decision making.Responsible for reviewing and coordinating approvals of R&D and GMA activities and programs in accordance with global/regional/country specific laws, regulations and company policies and procedures.
Manages the GC&E review and approval process to ensure interactions with and payments to HCPs, Government Officials, and other members of the healthcare community comply with company policies.Provides guidance to R&D and GMA organizations/functions to ensure proposed activities are in compliance with Teva Policies, functional and local SOP’s and adhere to applicable healthcare laws and regulations.Supports the identification, development and delivering of communications and training for internal and external partners to reinforce and instill compliance with the policies and processes related to R&D and GMA activities.Collaborates with Regional and Local Compliance colleagues, to ensure activities at the country and regional level are conducted in accordance with local laws as well as Company standards of conduct and industry best practices.Monitors approved EngageMate activities to ensure that (1) all required post-activity documentation is uploaded so that activities can be closed in a timely manner, and (2) information is provided to enable Teva to comply with transparency reporting obligations.Participates in cross-functional teams designed to ensure the effective/compliant implementation of programs and activities, including, but not limited to, the Global Compliance & Ethics teams responsible for EngageMate, transparency reporting, fair market value, monitoring, third party due diligence and data privacy systems.
Develops and implements compliance risk assessments and monitoring programs of activities and programs conducted by Global R&D and GMA and provides guidance to the functions on remediation actions needed.Any other duties or assignments as requested by the Global R&D Compliance & Ethics Officer and/or the Sr Director of NA Compliance & Ethics.Your experience and qualifications
A Bachelor’s Degree (BS/BA) is required. Advanced degree (Masters’ Degree or Juris Doctorate) is preferred.Minimum 8 years’ experience, preferably in healthcare environment and the pharmaceutical industry, with minimum of 3 years in compliance/risk related role.International experience.Experience in commercial, Medical Affairs and R&D functions.Strong project management skills with oversight experience in both internal and external projects.Strong interpersonal skills with demonstrated ability in participating and leading cross-functional teams, excellent skills in leading without authority and managing through influence.Pharmaceutical leadership, including experience in strategy development and interaction with business partners and third parties.Policy and procedure creation and implementation.Must have strong healthcare industry, including knowledge and experience working with Operations, Sales, Marketing, Legal, HR, and Regulatory.Experience in third party oversight.Ability to successfully partner with multiple business units and influencing others at all levels of the organization.Ability to take on large projects involving multiple stakeholders, multi-task, work independently and problem solve.Strong written/verbal communication skills -- ability to develop and deliver compelling presentations.Ability to think strategically and tackle complex problems.Ability to influence and impact without direct authority and develop strategic partnerships across functions.Strong executive presence and ability to interact effectively with all levels of the organization.Demonstrate intellectual curiosity and ability to identify trends/patterns.Ability to identify, advise on, minimize business risks, and propose practical solutions.Strong customer-orientation; an ability to see issues from the point of view of others.Ability to work successfully and cooperatively with colleagues across multiple cultures and time-zones.Knowledge of industry codes (PhRMA, EFPIA, IFPMA, ABPI), Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers, Anti-kickback Statute and False Claims Act and related enforcement actions.Knowledge of Foreign Corrupt Practices Act and UK Bribery Act.Knowledge of international regulatory requirements, including Good Clinical Practice, Human Research Protections, Declaration of Helsinki.TRAVEL REQUIREMENTS
Business travel will be required for some projects (approximately 20%).Enjoy a more rewarding choice
We offer a competitive benefits package, including:Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.Life and Disability Protection: Company paid Life and Disability insurance.Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible, Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
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