Objectives/Purpose (3-4 bullets)
Support complex legal agreements of the R&D organization.
Provide consistent legal advice on pharmaceutical product discovery, clinical trials, and research and development legal issues.
Contribute to a company culture that reflects a strong commitment to patients, trust, reputation, business, employee engagement, diversity and inclusion.
Accountabilities (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).
- Under appropriate supervision, draft and negotiate agreements covering basic to complex legal agreements of the R&D organization; including but not limited to, cinical trial agreements, consulting agreements, master services agreements, licenses, supply agreements, and development and manufacturing agreements.
- With Manager’s guidance and in collaboration with other R&D Legal professionals, ensure consistent legal advice on pharmaceutical product discovery, clinical trials, research and development legal issues including healthcare fraud and abuse, pharmcovigiliance, product liability, antitrust, privacy, and other matters relevant to the discovery and development of innovative pharmaceutical products and any supporting devices;
- For assigned areas and teams, provide legal support to development focused global product teams and/or functions;
- For assigned teams, serve as a legal representative on global product team(s) and coordinating with other global colleagues as needed;
- Identify and analyze specific legal and business matters under appropriate supervision, with a focus on enterprise-wide reputational risks to the company and propose appropriate solutions;
- Proactively coordinate with legal colleagues globally to contribute to and to stay abreast of global pharmaceutical laws and regulations;
- Foster strong relationships with colleagues in the R&D function, compliance, commercial law, intellectual property law and other related groups within the global enterprise to create efficient and effective processes with clients;
- Contribute to cultivating a company culture that reflects a strong commitment to ethics, patients, employee engagement, diversity and inclusion;
Dimensions And Aspects
- Technical/Functional (Line) Expertise(Breadth and depth of knowledge, application and complexity of technical knowledge)
- Basic understanding of research and development of innovative pharmaceutical products;
- Experience in drafting and negotiating clinical trial agreeements and complex contracts
- Basic understanding of US laws and regulations of drug research and development
- Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)
- Develop an enterprise view in developing and delivering legal guidance to client base
- Work with outside counsel as appointed
- Decision-making and Autonomy(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-soliving)
- Identify and as appropriate, contribute to leading and making process improvements to ensure optimal coordination of legal services and related functions to the global R&D organization
- Interaction(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
- Collaborate with legal and non legal colleagues that contribute to the company’s drug discovery and development efforts
- Innovation(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
- Have an interest in piloting new approaches to improve legal services in a risk appropriate way
- Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
- Experienced in drafting, negotiating complex legal documents in the pharmaceutical industry under appropriate supervision
- Experience in navigating successfully a highly matrixed global work environment
Education, Behavioural Competencies And Skills:(List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
- Knowledge of pharmaceutical industry and health care compliance requirements preferred.
- Minimum of 5 years in a law firm or in-house counsel role or similar experience drafting and negotiating complex contracts.
- Organized, responsible, detail-oriented and proactive.
- Capable of working independently and able to understand and incorporate legal guidance into work product.
- Strong communication and negotiation skills, ability to network across functions.
- Ability to multi-task and manage competing priorities.
- J.D. from an accredited law school
- Active membership and in good standing in a state bar