Entry to Mid-level Associate Attorney

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Entry to Mid-level Associate Attorney
The candidate will be drafting and making submissions to the FDA (e.g., 510(k)s, IDEs, PMAs, NDAs, INDs, De Novo's). Will be performing regulatory assessments of promotional materials (e.g., brochures, advertising, websites, social media posts, reimbursement materials, and marketing programs). Conducting legal and regulatory research. Communicating with the FDA as a client advocate (e.g., FDA pre-sub meetings, RFDs, and other FDA communications). Draft opinions regarding compliance with FDCA, AKS, FCA, PPSA, HIPAA, and other laws and industry codes. Design, deploy, manage, audit, and/or monitor health care compliance programs. Evaluate grant requests, clinical research arrangements, co-marketing programs, fee-for-service arrangements, government reporting, discounts, and sampling practices. Counsel clients on scientific exchange and reimbursement support. Draft and review research-related agreements (e.g., CTAs, ICFs, FUAs). Performing legal and regulatory training for clients. Respond to and resolve complaints made to clients by regulators and competitors. Support firm staff with QMS evaluations and remediation. Evaluate client practices for privacy compliance.

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