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Carrot Peelers, Sales, Personality and Your Job Search
In-House
Attorney
Health Care
Min 8 yrs required
Associate General Counsel, Healthcare Law Duties: Lead the healthcare law function. Will report to the General Counsel and manage development law, FDA regulatory legal support and be responsible for commercial compliance activities. Manage the operation of commercial compliance, working with the Commercial and Medical Affairs groups. Analyze and advise on legal obligations and rights to support achievement of Commercial and Development objectives. Work with third-party collaborators on Commercial issues. Provide advice with respect to rules and regulations governing the development and commercial launch and sale of products, including reviewing and approving publications and promotional materials. Participate on review committees with respect to medical publications, MSL materials, grants, sponsorships, speakers programs, consultant and advisory board meetings, grand rounds, and similar activities involving communications with healthcare entities. Provide legal protection and risk management advice to management. Lead the designing of policies, SOPs and training to comply with all applicable rules and regulations, including those of the FDA, OIG and CMS, and all applicable anti-kickback, privacy, fraud and abuse, anti-bribery and product liability laws. Assist in compliance monitoring, audits and investigations.
Qualification and Experience
Qualifications: JD Degree or equivalent. 8+ years of relevant experience in either a law firm or in-house, preferably in both. Experience working with biotech or pharma organizations with commercial products. Extensive knowledge of compliance functions in healthcare organizations. Motivated and passionate about making a difference for unmet needs in the antibacterial space. Strong communication skills and business partnering ability. Ability to strategically educate and support fellow employees. Ability to manage outside counsel, both nationally and internationally. Strong interpersonal skills and ability to work with others in a positive, collaborative manner, inspiring trust and confidence with colleagues. Committed to the values of integrity, accountability, transparency, scientific rigor and drive. Current US work authorization required. Ability to travel domestically and internationally.
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