Associate Senior Counsel- R&D

Posted 7 Days Ago
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Nutley, NJ
Senior level
Healthtech • Pharmaceutical • Manufacturing
The Role
The Associate Senior Counsel will advise Eisai’s R&D teams on legal matters relating to pharmaceutical research and development, including compliance, risk management, contractual issues, and privacy rights. The role includes drafting and negotiating clinical trial agreements and providing educational presentations.
Summary Generated by Built In

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 Summary

The 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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The Company
Nutley, NJ
2,984 Employees
On-site Workplace
Year Founded: 1985

What We Do

At Eisai Inc., human health care (hhc) is our goal. We give our first thought to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.

Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.

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