Development amp Regulatory Counsel

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Development & Regulatory Counsel
The candidate will provide strategic advice regarding research and development projects, business development matters, regulatory matters, compliance issues, development related documents and interactions with respect to pipeline pharmaceuticals. Provide advice regarding research and development, business development, product sourcing and development, and competition practices. Perform drafting and negotiation of development related documents for the local business and advise management in connection with related matters. Work closely with the transactional attorney and advise on specific regulatory or compliance risks, and counsel management in connection with related matters. Partner with legal department colleagues in executing and enhancing Company and Legal Department objectives. Supervise outside counsel. Responsible for increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the local business. Demand management is key, as is innovative solutions to meet client needs and address highest risks. Work as part of a matrix leadership team at MTDA and MTHA (handling matters including clinical, regulatory, safety, medical, sourcing, and finance). Responsible for assisting and supporting compliance function; helping to create and deliver policies and procedures and training to MTDA and MTHA teams. Lead by example and ensure consistent communication to clients, be a beacon of compliance and representative of the compliance program. Should have a Juris Doctorate (J.D.) degree from a nationally recognized law school. Admitted to the Bar of at least one state and eligible for admission to the New York or New Jersey Bar as in-house counsel. Must have 5-10+ years’ experience, with major law firm training (working with pharmaceutical clients) and/or in-house experience at a major pharmaceutical company handling a broad range of complex legal issues. Significant and extensive experience with clinical studies is required, including drafting and negotiating of clinical trial agreements, informed consents and other development related documents. Experience with FDA regulations and guidance provided by the Office of the Inspector General for HHS is required. Minimum of 5 years of legal experience, either in a law firm or in-house in the pharmaceutical or related industry, is required. Previous in-house experience with legal support for research & development is preferred. Experience with FDA laws and regulations and guidance provided by the Office of the Inspector General for HHS is required. Excellent oral and written communication skills; strong presentation skills, with the ability to communicate abstract ideas and legal advice to executive and senior management as well as non-legal colleagues and non-native English speakers. Excellent critical thinking skills; ability to work through complex issues, including those with significant strategic risk to the company. Strategic, analytical thinker and creative problem solver who possesses innovation, client management, demand management skills and regulatory knowledge. Selfless, promoting team and company objectives over individual accomplishments. Strong organizational skills with the ability to handle and prioritize a high volume of work and independently manage multiple complex projects simultaneously. Demonstrated broad understanding of the business environment and capable of anticipating future challenges resulting from change and the ability to adapt quickly and keep up with a fast‐paced and highly demanding environment and regulatory framework. Ability to respond resourcefully and strategically to shifting priorities and work effectively in ambiguous or challenging situations. Energetic self‐starter with demonstrated influencing skills and a results orientation. Must be able to quickly gain the trust and respect of senior executives, peers and clients. Ability to work both in a strategic big picture mode, as well as tactically, including the capability to “roll up one’s sleeves” and work in detail. Demonstrated client service orientation; able to recognize and respond quickly and pragmatically to urgent situations and demanding clients while setting demand management and expectations for highest priority matters. Flexible, and possessing a commercial, business focus in approaching this position. Knowledge of Japanese business practices is not required but would be ideal. Required to travel to New York City quarterly for department-wide staff meeting.

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