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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
Please note this position may be remote up to 3 days per week.
The successful candidate will be primarily responsible for providing counsel specific to Eisai's pharmaceutical regulatory needs, including sales and marketing, scientific exchange and other medical activities, monitoring, co-promotions, and FDA standards for a variety of pipeline and in-line assets.
Essential Functions
Provides proactive and day-to-day legal support, advice and counsel on a variety of commercial and medical matters relating to assigned products, including promotional and medical affairs materials, labeling, sales training and media/digital materials.
Works to ensure Eisai's compliance with pharmaceutical laws including the Anti-Kickback Statute, False Claims Act, PhRMA Code and FDA regulatory guidelines.
Serves as the legal representative on promotional and scientific review committees.
Manages the legal and reputational risks of assigned business clients.
Helps drive the implementation of legal strategy and policies.
Develops training content as needed on legal and other risks.
Requirements
* JD degree and 7+ years of legal practice including a minimum of 4 years focused on providing counsel to the pharmaceutical industry.
* Member in good standing of a state bar.
* Strong knowledge of FDA regulatory and fraud and abuse law.
* 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.
* Excellent level of oral and written communication skills, able to effectively present ideas, counsel and information to others.
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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:
E-Verify Participation
Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law. Eisai is an Equal Opportunity Employer – Minority / Female / Disability / Vet