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Reporting to the General Counsel, this position will provide a high quality and diverse range of legal and compliance support services, while exercising discretion, professionalism and solid judgment. This position will have a wide range of responsibilities, from drafting and negotiating agreements, to counseling on applicable State, Federal and International laws, rules and regulations. The role requires the ability to analyze, understand and assist in keeping in compliance with the myriad of laws, rules and regulations governing the Life Sciences industry today.
Essential Duties and Responsibilities include the following:
Participate in the development, implementation and monitoring of corporate policies, procedures and programs.
Resolve legal and compliance issues using negotiation skills and expertise.
Drafting and negotiating Life Science/Clinical or medical device related commercial contracts (e.g. supply, manufacturing, distribution, managed care).
Negotiating with sophisticated counterparties, such as hospitals, teaching institutions and universities.
Review and revise Master Services Agreements, Clinical Trial Agreements, Supply Chain Agreements, Vendor Agreements and other agreements as needed.
Ensure that HOYA conducts its business in compliance with applicable FDA, Fraud and Abuse, Anti-Kickback, FCPA, HIPAA, SEC, and other laws, rules and regulations.
Develops initiates, aligns, maintains, and revises policies and procedures for the general operation of the compliance program and its related activities to prevent illegal, unethical, or improper conduct to ensure alignment, communication and partnership in key cross-functional areas.
Collaborate with other departments (for example, Human Resources, Regulatory Affairs, Clinical Research, Medical Affairs, Sales & Marketing, Operations, R&D, Global Functions) to identify legal issues needed to be addressed and assist the business in achieving its goals/objectives in a legally compliant and ethical manner.
Ensure proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate or required.
Advising on mergers and acquisitions and general corporate governance matters.
Maintaining a current working knowledge of new laws and regulatory developments.
Anticipates internal and external business challenges and/or regulatory issues; recommends process, product or service improvements.
Other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience:
Juris Doctor (J.D.) - Qualified to practice law where based as in-house counsel; member of the Bar in good standing.
7+ years of corporate legal experience at a medical device, pharmaceutical, biotechnology, or other life sciences company or law firm.
Experience drafting and negotiating R&D, Medical Device related commercial contracts (e.g. Clinical Trial Agreements, Master Service Agreements (between Sponsor and Institution (Study sites) or CRO (on behalf of Sponsor) and Institution), confidentiality agreements, Informed Consent Agreements with Institutions/Study Sites and IRBs, and/or other agreements.
Experience providing legal advice for a wide range of regulatory matters, including, but not limited to FDA marketing (advertising, promotion, labeling), and sitting on a promotional review board.
Experience designing and implementing programs and policies pertaining to a variety of regulations, including, but not limited to, Fraud and Abuse and Stark/Anti-Kickback issues.
Must be able to travel up to 20% of the time including international travel, and have an acceptable Motor Vehicle Record (MVR) per Hoya’s MVR policy.
About HOYA: Founded in 1941 in Tokyo, Japan, HOYA is a global technology and med-tech company, and a leading supplier of innovative high-tech and medical products. HOYA is active in the fields of healthcare and information technology providing eyeglasses, medical endoscopes, intraocular lenses, optical lenses as well as key components for semiconductor devices, LCD panels and HDDs. With over 150 o...ffices and subsidiaries worldwide, HOYA currently employs a multinational workforce of over 34,000 people. For over 60 years, HOYA Vision Care has been a global leader in the eyeglass lens business. With a presence in over 50 countries, HOYA Vision Care has a proven expertise in lens designs and FreeForm technology combined with a leading position in high performance, quality AR coating. HOYA Vision Care’s solid market portfolio includes SEIKO and PENTAX optical lenses, as well as innovative products such as HOYALUX MyStyle Progressive Lenses and Yuniku 3D Tailored Eyewear. The company employs over 16,000 vision care employees worldwide with mass production facilities in Asia & Europe and over 40 local Rx laboratories globally. For more information, please visit http://www.hoyavision.com.