Senior Counsel, Regulatory
The candidate will be responsible for counseling on FDA laws, regulations, and guidance documents with respect to complex regulatory issues relating to the development, approval, and marketing of medical devices; product cybersecurity; lifecycle management; as well as inspectional and product safety/quality issues. Collaborates with cross-functional teams and counsels a variety of clients across **MEMBERS ONLY**SIGN UP NOW***.â€™s medical device businesses on modera...
The candidate should have 3-8 years of regulatory and transactional healthcare or FDA experience. The Healthcare Attorney supports the Firmâ€™s practice by providing legal strategies and solutions to the Firmâ€™s diverse clients, which include physicians, healthcare startups, dietary supplement and medical device companies, medical management companies, medical mobile app developers, and health technology companies. Provides unparalleled, valu...
Palo Alto office of our client seeks healthcare attorney with 3-8 years of regulatory and transactional or FDA experience. The candidate supports the firm’s practice by providing legal strategies and solutions to the firm’s diverse clients, which include physicians, healthcare startups, dietary supplement and medical device companies, medical management companies, medical mobile app developers, and health technology companies. A portable book of business is obviously de...
Corporate Counsel, Commercial and Healthcare Transactions
The candidate will draft, review, and negotiate a wide range of contracts needed for the effective functioning of the Company, including clinical study agreements, material transfer agreements, vendor agreements, license agreements, distributorship agreements, services agreements, consulting agreements, payor network agreements, NDAs, etc. Perform legal review and approval of other company documents, such as clinica...
Senior Director, Healthcare Attorney
The candidate will be responsible for providing food and drug law-related legal support to the company. The position reports to the Vice President, Legal. Provide legal support to Regulatory Department relating to regulatory legal issues including FDA correspondences and meetings, labeling negotiations and NDA/BLA submissions. Review all product-related communications including press releases, MSL materials, advertising, copy and promot...
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The candidate must have in-depth experience in Medicare to research and analyze new coverage guidelines and preparing and filing necessary applications. Expertise in Medicare issues is required.
Candidate will: Provide healthcare compliance and FDA regulatory legal support and be responsible for Healthcare Compliance program implementation, training, communication, monitoring, auditing and enforcement activities. Manage the operation of Compliance Program, working under the direction of the Healthcare Compliance Officer. Provide advice with respect to rules and regulations governing the commercial launch and sale of products. Review and approve ...
The candidate will provide product and compliance guidance in two U.S. therapeutic areas and support client groups, such as Marketing, Sales, Medical Affairs, and Public Affairs. Will work in handling promotional and educational activities, engagements with healthcare providers, and applying commercial law and regulatory compliance knowledge to the biotech/pharmaceutical industry. Negotiate and draft a full spectrum of legal agreements, supervise paralegals...