Legal Director, Global Medical Affairs & Pipeline

Provide clear, practical legal advice and support to Medical Affairs on a wide range of activities, including scientific communications, medical education, publication planning, advisory boards and investigator-initiated studies Advise on interactions with healthcare professionals, scientific experts and patient advocacy groups, collaborating with E&C as appropriate, to ensure adherence to anti-kickback / anti-bribery and other compliance requirements Support the development and implementation of medical and E&C policies, standard operating procedures (SOPs) and training materials for Medical Affairs colleagues Exceptional oral and written communication skills, including drafting skills and presentation capabilities Excellent interpersonal and conflict resolution skills and ability to work in highly collaborative, team-oriented environment Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations History of self-motivation, working independently on projects, meeting aggressive deadlines and juggling multiple matters High integrity and demonstrated ability to treat confidential information with great discretion Able to exercise good judgment, be forward looking and remain solution-oriented across a variety of situations JD from an ABA-accredited law school; admitted in good standing to at least one U.S. jurisdiction Minimum of 8 years post-JD experience advising on legal matters in a life sciences space, whether in a law firm or in-house in the biopharmaceutical industry or both Deep understanding of the pharmaceutical business and related legal issues and solid practice advising the pharmaceutical, biotech, healthcare or life sciences industry, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, state and federal privacy laws and product liability laws. Working knowledge of the European general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the European legislation on medicines for children and for rare diseases (Regulation 1901/2006 and Regulation 141/2000/EC, respectively), as well as of the main industry codes (EFPIA, ABPI) a plus Reviewing materials for Medical Affairs teams to use with external stakeholders, such as healthcare professionals and patient advocacy groups; and Setting up and supporting Medical Affairs research, negotiating with research institutions, and advanced contracting and redlining skills with strong attention to detail Excellent analytical, problem-solving and organizational skills to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards Ability to effectively and efficiently manage outside counsel and adhere to a budget