Director, Senior Counsel, Global R&D Compliance

Teva Pharmaceuticals•West Chester, IA

12d•Hybrid

About The Position

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.The opportunityThe Director, Senior Counsel, Global R&D Compliance role reports into our Global R&D, Quality, and Regulatory Legal organization. This position will provide legal support for current Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) quality, compliance, investigation, and enforcement activities, worldwide. It will also provide legal counsel, reviewing and negotiating agreements relating to clinical trials, research and development, data privacy, pharmacovigilance, and other R&D-related matters, worldwide. This role counsels clients on a wide range of regulatory compliance issues with a focus on current GCPs and GLPs, including quality and contracting processes related to the research and development of innovative, biosimilar, and generic pharmaceuticals around the world. The attorney will 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. The attorney will also support clinical research and development activities, working closely with cross-functional teams to ensure compliance and provide practical, business-oriented legal advice that supports Teva’s Pivot to Growth strategy.

Requirements

Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.
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.
Solid understanding of legal and regulatory frameworks related to clinical research and drug development.
Strong contract drafting and negotiation skills.
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. This individual will be highly visible at all levels of the organization and must be able to build trust and credibility.
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.

Nice To Haves

Clinical and/or GCP/GLP quality experience highly valued.
Manufacturing and/or GMP quality experience preferred.
Past experience working for a health authority (e.g., FDA, EMA) preferred.

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.

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.

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