Director, Senior Counsel, Global R&D Compliance

Who we are

Together, 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. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The 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.  

How you’ll spend your day

• 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.

 

This role is hybrid based in the West Chester, PA office however we may consider Parsippany, NJ or remote for the right individual. 

Your experience and qualifications

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.
• 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 is