At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Job SummaryThe position's primary focus shall be to advise Eisai's R&D clients on various legal, compliance and liability matters; interpret and apply relevant laws, regulations and requirements; dispute management and resolution; risk and liability management in global operations and on day to day activities; advise on contractual matters; address emergent issues and identify systemic concerns and considerations; advise on privacy and human subject protections, GCPs, scientific exchange, publications, IP and related rights; and coordinate advice of legal experts on critical issues and concerns (e.g., activities ex-US, cutting edge/breaking issues, enforcement concerns).
The position will also draft and negotiate R&D pharma-related commercial contracts (e.g. clinical trial agreements, master service agreements, confidentiality agreements, informed consents, and/or other agreements).
Prepare and provide educational presentations and develop policies, SOPs and procedures for local and global application.
Qualifications- 6+ years as a practicing, licensed attorney with client contact and varied responsibility
- 3+ years prior experience advising on issues related to research and development in the pharmaceutical industry:
- Knowledge of FDA regulations and guidance, and corresponding state laws relating to clinical research and development, compliance and liability matters.
- Knowledge of pharmaceutical industry and ability to identify relevant legal issues and risks.
- Knowledge in a range of legal areas of relevance to the company's operations.
- Member in good standing of a state bar.
- Good level of multi-tasking ability.
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Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
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