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Date Last Verified
Years of Experience
ProfileSenior Counsel The candidate will provide assistance to the SVP, General Counsel in a broad range of legal department responsibilities including commercial and other contracts, employment, CMC and manufacturing, compliance, privacy, regulatory, intellectual property and internal and public communications. Will be responsible for providing clear legal advice and practical results-oriented, business-focused solutions enabling the business to achieve its objectives while preserving and protecting the company's integrity and reputation. Will have significant depth of experience working for public or private companies, preferably in the biotechnology and/or biopharmaceutical industries. Works closely with key stakeholders in the organization to review key business strategies and provide legal advice to multiple functions, including technical operations, commercial operations, medical and clinical affairs, IT, research and development, supply operations, HR and facilities. Drafts and negotiates a wide range of legal documents typical of a biotech or pharmaceutical organization, including master service agreements, supply agreements, materials transfer agreements, clinical trial agreements, license agreements, manufacturing agreements, confidentiality agreements, research collaborations with academic institutions, agreements with governmental entities, vendor agreements and other general business contracts. Advises internal clients on contract interpretation, dispute resolution and other legal risks associated with all aspects of the companyâ€™s business. Assist with the development of company policies and procedures, and standard template language to be used in contracts. Advises internal clients on product supply chain, including manufacture, distribution, reimbursement and price reporting. Participates in the selection and management of external legal counsel including cost effectiveness. Conducts due diligence evaluations for possible business transactions. Monitors regulatory and clinical activities for legal compliance. Ensures coordination with internal legal department and non-legal departments and directs the escalation of issues driving them to resolution. Develop and continually expands a thorough understanding of firm's current and planned business activities, programs, competitors, and markets and keeps abreast of developing legal trends, laws and regulations. Provide support for company litigation as needed. Research unique legal issues impacting the organization and its business by identifying applicable statutes, judicial decisions, and codes. Provide training to company and its affiliates on substantive legal topics. Other duties as assigned.
Qualification and Experience
The candidate should have JD degree and requisite active Bar licensure, preferably in CA. Must have 8 of years of relevant experience required with at least 5 years as in-house counsel at a public or private company. In-house counsel experience in the field of biotechnology/pharmaceutical research and development and its related FDA regulations is preferred. Ability to understand and negotiate details and nuances of contract language is required. Must have broad knowledge of the legal and regulatory framework for the development, manufacture, distribution and commercialization of pharmaceutical products. Must have experience representing public and private companies.
Job ID 2018-1262
1700 Saturn Way
Seal Beach, CA 90740