Brand Lawyer

Profile

Brand Lawyer
Duties: The candidate provides legal support for the pharmaceutical affiliates and report to the Deputy General Counsel. Provides legal services and support, primarily to the company and its affiliated companies. Gives advice on legal and regulatory issues as they arise from the marketing, sales, medical, market access, operations and executive teams. Involves all aspects of the commercial business and operate as part of a team focused on supporting an orphan drug in the U.S. Reviews promotional and nonpromotional/scientific materials and strategies, evaluating strategic and tactical commercial/brand and medical affairs plans, supporting clinical educator programs, and advising clients on a broad array of issues relating to FDA pharmaceutical regulations, advertising, marketing, product development, product labeling, promotional review, media materials, anti-trust, anti-kickback, competitor issues, market access issues, regulatory policy, medical, pricing, reimbursement, privacy, sales, industry and group company issues, and transactional matters. Works on cross-functional business teams, including direct contact with senior leaders including the President. Advises the transactional attorney on regulatory and compliance risks. Advises on the proper review of promotional materials and tactics including social media and healthcare professional and consumer-directed advertising as well as nonpromotional/scientific pieces and scientific exchange materials. Participates in review committee meetings. Provides strategic advice regarding customer and other stakeholder relationships, regulatory matters, contracts and interactions with respect to branded/specialty pharmaceuticals. Ensures optimal advice regarding sales and marketing, interactions with healthcare professionals, interactions with patients and patient advocacy groups, clinical educator programs, market access, medical affairs, product sourcing and development, and competition practices. Works closely with the transactional attorney and advises on specific regulatory or compliance risks, and counsels management in connection with related matters. Partners with legal department colleagues in executing and enhancing Company objectives. Supervises outside counsel. Drives increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the local business. Demands management is key, as are innovative solutions to meet client needs and address the highest risks. Works as part of a matrix leadership team at MTPA (handling matters including commercial, medical, operations and HR). Assists in supporting compliance function; helps to create and deliver training to clients. Leads by example and ensures consistent communication to clients; serves as a beacon of compliance and representative of the compliance program.

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