Hybrid Director, Senior Counsel, Global R&D Compliance

at Teva Pharmaceuticals

• Job title: Director, Senior Counsel, Global R&D Compliance
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Professional Certificate
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, West Chester, United States

About the role

• Director, Senior Counsel providing legal support for global R&D compliance at Teva Pharmaceuticals. Collaborating with teams to ensure regulatory compliance in innovative and generic pharmaceuticals.

Responsibilities

• Counsel clients on a wide range of regulatory compliance issues with a focus on current GxP practices, quality processes, and contracting related to the research, development, manufacture, and distribution of innovative, biosimilar, and generic pharmaceuticals, worldwide.
• Work collaboratively with cross-functional teams to develop and implement communications with global regulators, including responses to health authority inspections and inquiries, and on remediation and corrective action plans.
• Draft, review, and negotiate a wide range of R&D-related agreements, including: Clinical trial agreements, Consultancy and service agreements, Research collaborations and MTAs, Investigator-initiated study agreements, Licensing agreements, Academic collaboration and research consortium agreements.
• Participate in internal meetings to review quality metrics, participate in site or project governance committees, and facilitate internal audits.
• Partner with Compliance to provide legal support for internal investigations.
• Work cross-functionally with Quality, Regulatory, IP, Compliance, Privacy, and other stakeholders to support process and system improvements, including development of global policies and training materials.
• Monitor and participate in the external policy environment and advise teams on policy and regulatory developments related to R&D activities.
• Manage a legal budget and ensure alignment with financial targets.
• Manage outside counsel who provide services in support of this role.
• Provide training to management and employees on emerging and/or hot legal topics.

Requirements

• A Juris Doctor (JD) degree from a top-tier law school is required.
• A minimum of 7 years prior experience at a law firm and/or in-house legal department.
• Clinical and/or GCP/GLP quality experience highly valued.
• Manufacturing and/or GMP quality experience preferred.
• Solid understanding of legal and regulatory frameworks related to clinical research and drug development.
• Strong contract drafting and negotiation skills.
• Past experience working for a health authority (e.g., FDA, EMA) preferred.
• Admission to practice law in the bar of a relevant jurisdiction/ability to be house counsel.
• Demonstrated excellence in (i) understanding complex scenarios in order to identify and evaluate relevant issues and risks; (ii) proposing solutions that take into consideration the relevant business objectives; and (iii) communicating those issues, risks, and solutions clearly and concisely.
• Strong interpersonal skills and an ability to work collaboratively, with a solution-oriented approach, in global, cross-functional teams within legal, compliance, business, and other functional areas.
• Strong relationship-building skills, able to influence internal and external stakeholders.
• Strong foundation of analytical skills, verbal, and written communication skills.
• Strong organizational skills and an ability to handle multiple responsibilities simultaneously and still meet quality and timeliness standards under pressure.
• Self-motivation, an ability to work proactively and independently, reliability, responsiveness, and accountability.
• Intellectual curiosity, with a commitment to continuous learning and improvement.
• Sound judgment, commitment to ethical conduct, and a high level of professionalism.
• Up to 15% travel, including international, as needed.

Benefits

• 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 and 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.