In-House Counsel Position Opening (4+ years exp.) - Eisai (Woodcliff Lake, NJ)

18 Apr 2016 10:32 AM | Melinda Cox (Administrator)

Eisai is looking for in-house counsel in its Research and Development Legal Operations Department.

Job Description 

With supervision, provide legal advice, counsel and service to Eisai’s Oncology Business Unit and other assigned internal clients on legal matters, with a focus on counseling the research and development arms of the unit and related functions such as Regulatory Affairs, CQA, Medical Affairs, Medical Services, MSLs, Clinical Operations.

The position’s primary focus shall be to advise 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).

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.

Provide legal advice for a wide range of regulatory matters affecting the unit, including, but not limited to FDA sales and marketing (advertising, promotion, labeling) activities.

Essential Functions:

  1. Provides proactive and day-to-day advice and counsel to assigned business clients.
  2. Proactively informs assigned business client of important legal, enforcement and other industry developments.
  3. Within supervision, manages the legal and reputational risks of assigned business clients.
  4. Assists with the implementation of legal strategy and policies.
  5. Assists with the development of training content needs and deliver training throughout the company on legal and other risks.
  6. Works with legal department colleagues from ENW companies and alliance partners on global issues as needed.

Job Qualifications:

  • 4+ years as a practicing, licensed attorney with client contact and varied responsibility
  • 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.
  • Basic knowledge of pharmaceutical industry and ability to identify relevant legal issues and risks.
  • Basic 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.
  • Ability to learn quickly and operate in a fast paced, matrixed environment
  • Able to participate on key teams and/or be involved in key projects.
  • Developing leadership and managerial skills.
  • Seeks to develop mentoring skills.
  • Good level of oral and written communication skills, able to effectively present ideas, counsel and information to others.
  • Ability to command respect from management.
  • Demonstrates the following key leadership competencies: Embraces and Sells the Vision, Leads Innovation and Change, Promotes Accountabilities, Drives for Results, Leverages Business Acumen, Focuses on Customers & Business Partners, Builds Organizational Talent
All interested applicants should apply online at: http://us.eisai.com/eisai-careers/career-opportunities.