Senior Counsel, Clinical Trials EMEA - Janssen Pharmaceuticals - Beerse

The Role

The Senior Counsel will provide general legal support for clinical trial contracting and other clinical research-related documents and agreements, including contract drafting, negotiation, developing training and guidance documents. This position will also provide legal support for cross-regional matters related to early development and late stage clinical trial-related contracting, investigator-initiated study agreements, collaborative research, and various vendor agreements supporting clinical research within Johnson & Johnson’s pharmaceutical business.

Responsibilities

• In charge of providing practical and timely guidance on clinical research-related contract matters in Europe, the Middle-East and Africa (EMEA), with a focus on Central & Eastern European countries, including contracts within the Johnson & Johnson R&D Procurement category.
• Responsible for drafting and reviewing (Master) Clinical Trial Agreements, Alternate Clause (Fallback) documents, CRO and other clinical research-related vendor agreements, including Master Services Agreements for cross-regional use and other related documents and templates.
• Handle contracting support for investigator-initiated study agreements, collaborative research and government-funded research projects such as IMI initiatives, as well as preparing guidance and training materials to support the efficient and compliant negotiation of clinical research-related contracting activities.
• Internal and external point of contact for contract negotiations and will work closely with legal colleagues in the regulatory, patent and litigation groups within Johnson & Johnson.
• Collaborates with other regional clinical trial lawyers as well as cross-functional teams including clinical operations, clinical therapeutic area teams, medical affairs, regulatory affairs, healthcare compliance, tax and other business functions to support initiatives in furtherance of the company’s clinical trial activities and develop policies and practices facilitating consistent and efficient support for clinical trials.
• Work will be in a multi-disciplinary, diverse environment, and in close connection with European, US, Latin American and APAC legal colleagues.

• A Law degree with a minimum of 7 years of legal experience, preferably 5 years supporting clinical trial or other clinical research-related agreements, including 2 years of experience as in-house counsel.
• Experience drafting and negotiating clinical research-related agreements.
• Good knowledge of current laws, regulations and industry standards governing R&D and clinical trials, such as national and European rules and regulations, ICH Guidelines, and GXPs is required.
• Excellent understanding of contract law, strong communication, drafting and negotiation skills and the ability to influence and work collaboratively at all levels and across functions is also a requirement.
• Fluency in English, with the capability of drafting contract terms and conditions in English, is required.
• A successful candidate will have acquired a Law degree with excellent results, an ability to operate effectively within a dynamic and ambitious international environment, and a passion for the healthcare industry.