Senior Counsel

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Senior Counsel
The candidate will report to the General Counsel. Will provide advice and counsel on regulatory, compliance and commercial issues. Duties include: providing legal advice related to the development and distribution of FDA regulated medical devices globally; review of a high volume of promotional content for sales and marketing and other content for healthcare professionals, patients, and managed care organizations as well as internal/external training and similar material; routine counseling on healthcare compliance issues including close interaction with the General Counsel and the executive management team; and providing support to general legal needs of the company, such as drafting and negotiating contracts in support of the business. Review product labeling/marketing materials. Collaborate with Commercial and Medical Affairs team members to create solutions for developing compliant relationships with healthcare professionals and government officials. Provide counsel on FDA and international regulatory approval for medical devices and prescription drugs. Prepare, negotiate and review a wide variety of contracts including, clinical trial, registry, research and consulting agreements, software licenses, NDAs, product design and manufacturing agreements, distributor agreements (structure and negotiate incentive programs), etc. Assist with the compliance function and collaborate with compliance to implement policies and procedures to ensure compliance with government and industry initiatives and regulations (legal/ethics requirements for medical device manufacturers, anti-kickback law, anti-trust issues, anti-bribery, etc.). Provide training on a wide range of issues related to labeling and promotional content, reimbursement, best practices, FDA regulatory issues, etc.

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