Job Brief (Primary Responsibilities)
Provide legal advice on contracts, legal risks, and business terms related to manufacturing and supply chain/procurement
This position will provide legal advice on contracts, legal risks, and business terms related to manufacturing and supply chain/procurement. The individual will be required to develop a good understanding of the Company’s operations and possess the ability to evaluate and balance both legal and business factors when providing recommendations. The successful candidate will have a broad knowledge base in areas appropriate for an experienced in-house counsel at a medical device company.Primary Responsibilities:
- Serve as primary legal support for manufacturing, operations, and supply chain functions, but will assist in other areas, including commercial, clinical, and research and development. This includes identifying and assessing legal risks and opportunities and providing solutions-oriented legal advice and counsel; providing thorough and reasoned analysis of complex legal issues; and using in-depth knowledge of the company, relevant laws and regulations and industry best practices impacting the commercialization of medical device, biotech, and pharmaceutical products.
- Draft, review, and negotiate various agreements, including domestic and international manufacturing/supply contracts with suppliers of materials or services, clinical trial agreements, professional services agreements, consulting agreements, branding/marketing/PR agreements, joint venture agreements, consents/permissions forms, confidentiality agreements, distribution agreements, specialized product purchase/use agreements with physicians, and other miscellaneous contracts and corporate documents.
- Support internal stakeholders in selection and management of suppliers, thereby ensuring a reliable and robust supplier base.
- Collaborate cross-functionally to advise and support a highly effective supplier quality management program, including identifying problem areas and assisting with implementing contractual obligations and requirements to address quality issues.
- Advise business stakeholders throughout the contract negotiation process with respect to the areas of legal risk and exposure, while recommending strategies to achieve a satisfactory outcome.
- Create and modify appropriate template contracts tailored to the business needs; draft agreements that minimize risks and maximize legal rights.
- Demonstrate ability to think creatively and devise solutions to challenging problems.
- Advance a positive spirit of solution-oriented partnership and collaboration with internal clients, internal legal colleagues, and outside counsel.
- Recognize and escalate matters of specialty, or unusual complexity or risk as appropriate.
- Adept at understanding the motivation and needs of others and effectively communicating with a diverse audience, including senior leaders, in a manner that generates confidence and support for proposals/recommendations.
- J.D. from a nationally recognized accredited law school
- 8+ years law firm or in-house experience drafting and negotiating agreements including significant experience with transactions in the medical device, biotech, or pharmaceutical industry.
- Be a member in good standing of the State Bar of California, or ability to acquire status of Registered In-House Counsel from the California Bar
- Detailed knowledge of Food and Drug Administration and other government regulation of marketing and advertising of medical device, biotech or pharmaceutical products is very helpful.
- Familiarity with these additional areas is also helpful: federal, state, and international healthcare laws and regulations including GMP obligations, process validation and scale-up, global privacy (GDPR), FCPA, Anti-Kickback Statute, False Claims Act, HIPAA, privacy laws, advertising laws, regulatory guidances, and legal contract principles.
- Must have demonstrated high EQ and client-service orientation; able to recognize and respond quickly and pragmatically to urgent situations and demanding clients.
- Willingness and ability to work with and coordinate activities across a large number of individuals in various departments and geographies.
- Ability to assist other attorneys on an as-needed basis in providing effective legal support for company stakeholders.
- Ability to work on cross-border transactions and/or international legal matters.
- Appropriately triage a heavy workflow, setting appropriate priorities with clients and delivering results within the reasonable agreed timelines.
- Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
- Strong understanding of medical device, biotech or pharmaceutical operations and the ability to create policies and programs that work for the business.
- Strong knowledge of contract documents and concepts and strong drafting and negotiation skills, attention to details is important.
- Understanding of, and experience with, regulatory framework applicable to interactions with healthcare professionals, patient privacy, and related issues
- Proven track record of delivering consistently on complex projects under challenging circumstances with a sense of urgency, but with the ability to also keep broader strategic objectives in focus.
- Ability to communicate effectively both verbally and in writing in both individual and group settings and across cultures.
- Ability to work calmly under pressure, prioritize and manage a significant number of projects simultaneously under tight deadlines, and to thrive in a dynamic and fast paced environment.
- This position is based in Concord, California, however remote candidates will also be considered.
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