AbbVie's Clinical R&D Legal team is seeking an experienced attorney to partner with, and provide strategic legal and business advice to, the company's global R&D organization. The Corporate Counsel, Clinical R&D Legal, will be an integral part of a solutions-oriented team of attorneys and paralegals that supports advancement of AbbVie's pipeline and delivery of innovative products to patients. The attorney will provide advice on a wide range of legal, regulatory, contractual, privacy and compliance issues related to clinical research and drug, medical device and aesthetic product development in European Union with a focus on Italy. For candidates with strong leadership and critical thinking skills, this role provides the opportunity to work cross-functionally with teams across research and development, regulatory, intellectual property, privacy, and ethics and compliance. In this role, the Corporate Counsel will be expected to interact regularly and effectively with management, internal business stakeholders, and third-party partners. They must be creative, strategic, and innovative in compliantly solving complex legal problems, advising clients on such matters, and negotiating critical clinical agreements to advance AbbVie's clinical assets.
Core Job Responsibilities:
Drafting, reviewing and negotiating a wide variety of agreements, including clinical study and collaborative research agreements, services agreements in support of AbbVie's clinical research operations and other transactional and complex R&D agreements with research partners.
Developing and reviewing patient informed consent forms for use in clinical research and incorporating feedback from regulatory authorities and/or ethics committees.
Serving as a subject matter expert on R&D legal and regulatory matters in EU with a focus on Italy to advance clinical assets in this region.
Conducting training to client groups on a variety of R&D legal and regulatory issues.
Advising the AbbVie Clinical Development and Medical Affairs organizations in connection with clinical research activities throughout the phases of clinical development.
Clearly communicating legal guidance on complex matters related to clinical research, including study participant privacy and rights, data integrity, site and investigator non-compliance, fraud and abuse matters and digital health.
Collaboratively interacting with internal business stakeholders, other Legal functions, Office of Ethics and Compliance, regulatory, third-party partners, and R&D and Legal leadership.
Qualifications
Must possess a law degree and meet the professional licensing requirement applicable in the European Union.
At least five (5) years of experience advising on R&D clinical legal issues, such as clinical trial design, and working understanding of laws and regulations impacting clinical research and development of drugs, medical devices, and aesthetics products in the EU region with special focus on Italy. Some in-house experience preferred.
Ability to support achieving business objectives by providing clear and practical counsel, including evaluating and managing risk, and to use legal training to maximize business opportunities.
Excellent legal analysis skills, good judgment and the ability to identify and quickly address critical issues.
Strong interpersonal skills, including diplomacy and flexibility, and the ability to communicate concisely and effectively with partners at all levels.
Ability to work well independently and on a team and can prioritize multiple matters.
Must be proficient in Italian and English.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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