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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 ... read more
Senior Corporate Counsel, Global Privacy
The candidate serves as the company’s Chief Privacy Officer and administers the company’s global data privacy program. Serves as information privacy consultant to Company employees, and provides legal analysis and advice on privacy and data protection topics, including HIPAA and state privacy laws, EU data privacy regulation (including General Data Protection Regulation and Privacy Shield), FTC consumer privacy regulations, data... read more
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... read more
Regulatory Compliance Audit Manager
The candidate will identify and call attention to compliance and repetitional risks through assurance audits, consulting, and solutions management activity; improve the effectiveness of Alphabet’s governance, risk management, and internal control activities. Will manage work requirements and budget to meet team initiatives; communicate with and educate process owners effectively, including non-finance individuals, on the importance of ...
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...
Corporate Counsel R&D
The candidate will be responsible for supporting and advising clinical development, regulatory strategy, pharmacovigilance and other R&D clients on a broad array of issues relating to FDA pharmaceutical regulations, GxP requirements, product development, product labeling, interactions with healthcare professionals and patients, anti-trust, anti-kickback, competitor issues, compliance issues, regulatory policy and industry developments and issues. Resp...
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***.’s medical device businesses on moderately ...
The candidate will advise on the interpretation of laws, regulations, and guidance related to federal and state healthcare law. Will execute on and tracks the operational requirements across the different jurisdictions in which Lyra Health and affiliated entities operate. Review and negotiation of contracts supporting the company, focusing on healthcare regulatory issues. Assists with legal compliance and the assessment of risk to the organization.