Responsibilities
- Manage day-to-day legal affairs of certain Fujifilm Life Sciences companies under general supervision of Assistant General Counsel, Life Sciences and provide secondary support to related Fujifilm medical device and pharma companies as needed, in coordination with other Fujifilm attorneys located both in and outside of the United States, as needed.
- Provide guidance on FDA promotional labeling requirements, including review of marketing and advertising materials, company presentations and press releases. When necessary, collaborate with regional/global stakeholders on comparable requirements in other jurisdictions.
- Advise, counsel and report to management on general legal and regulatory risks, including with respect to FDA regulations and other regulations applicable to life sciences and healthcare companies, such as anti-kickback statutes, U.S. government programs and contracting compliance requirements, anti-trust laws, HIPAA and data privacy and security, and state licensure laws.
- Directly draft, review and negotiate a variety of complex commercial contracts, including customer, distributor and vendor agreements; non-disclosure agreements; development, manufacturing and service agreements; and quality agreements and clinical trial and research agreements; among others. Work with internal colleagues and outside counsel on a regular basis to review and handle a large volume of contracts, to ensure agreements mitigate legal risk and support business objectives.
- Perform general corporate and pre-litigation/litigation work to minimize risks and maximize legal rights, in coordination with Fujifilm litigation management counsel.
- Provide legal support to the development and structuring of new business ventures.
- Keep abreast of legislative and regulatory changes that may affect HLUS and its subsidiary companies.
- Provide training to HLUS and its subsidiary companies on substantive legal topics relevant to life sciences/pharma/medical device business and other health care matters.
Required Skills/Education
- College degree and juris doctorate from accredited law school. Academic honors preferred.
- Admitted to at least one state bar in good standing.
- 6-8 years of relevant experience in a corporate law firm, in-house or government agency legal department in the life sciences, pharma, medical device or other health care field.
- Solid commercial contract background with extensive drafting and negotiation experience.
- Skill in providing regulatory advice in a complex business environment.
- Ability to timely, effectively and autonomously manage multiple complex projects, to collaborate with internal and external stakeholders and to drive contracts and other legal projects to completion.
- Computer skills in appropriate applications.
Desired Skills
- In-depth knowledge of FDA regulations, including advertising and promotion requirements and other regulations specifically applicable to the life sciences/pharma and medical device industry
- Management skills
- Experience managing outside counsel and/or legal staff
- Analytical Ability
- Budget Conscious
Salary and Benefits:
- $180,000 - $190,000 depending on experience
- Medical, Dental, Vision
- Life Insurance
- 401k
- Paid Time Off
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EEO/AGENCY NOTES
Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.
To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.
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