Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Assistant General Counsel – Legal Regulatory and Compliance is responsible for managing a breadth of complex global legal regulatory and compliance matters related to commercial vaccines and pharmaceuticals and medical countermeasures products for the Devices, Vaccines, and Therapeutics Business Units by providing practical, timely, strategic and high-quality legal advice to a broad spectrum of clients across the organization. This is a highly strategic position and is accountable for balancing United States and global opportunities with associated legal and compliance risks in a complex and fast-evolving regulatory environment. This position is also accountable for collaborating with other members of the Legal Team and Ethics and Compliance to proactively identify and mitigate regulatory and compliance risks to the Company’s ability to achieve its strategic corporate operating plan (COP).
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Assistant General Counsel Legal Regulatory and Compliance will serve as a strategic legal partner to business unit leaders and their teams by leading and overseeing a range of strategic legal support, advice, and counseling, taking into account the domestic and global objectives of the organization and the unique global, regional and local legal and regulatory requirements. In this regard, the Assistant General Counsel Legal Regulatory and Compliance will also align, coordinate and work closely with members of the Legal, Ethics & Compliance, Medical Affairs, Regulatory, International medical countermeasures (MCM) procurement, and Global Government Affairs teams as needed or appropriate.
- Collaborating with intellectual property, commercial, and medical countermeasures attorneys on regulatory and compliance issues in a broad range of complex agreements, including agreements for research and development collaboration, sponsored research, clinical trials, expanded access, compassionate use, patient recruitment, informed consents, non-interventional studies, sponsorships and grants, advisory boards, data sharing and data licensing, investigator-initiated trials, and regulatory, quality, and pharmacovigilance agreements.
- Leading and/or and overseeing a full range of legal regulatory support for clinical development and medical affairs activities throughout the life cycle of all development programs and products including IND, NDA, and BLA filings and emergency use authorizations. Such support includes providing legal advice, including the legal interpretation of laws, rules, regulations, and guidance documents relating to the development of vaccines, biologics, and other pharmaceutical products.
- Together with members of the MCM Legal Team, provide legal support to the International MCM Procurement Team and Medical Affairs in support of international procurement of medical countermeasures.
- Together with other members of the Legal Regulatory and Compliance team, contribute to the establishment of governance and processes to develop a globally consistent approach to Legal Regulatory support taking into account unique aspects required for particular client groups as well as specific legal requirements for the countries in which the commercial products teams and MCM procurement team operate.
- Representing the Legal department on various senior management cross-functional teams and/or committees.
- Retaining, supervising and directing outside counsel effectively and efficiently managing legal expenses consistent with the Legal operations budget.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects managements assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Law Degree from an ABA accredited school and licensed and in good standing in at least one U.S. State
- At least 10 years of experience working in a law firm and/or pharmaceutical or biotechnology legal department.
- Deep understanding of the legal issues affecting the pharmaceutical industry, including regulatory processes for prescription drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption and antitrust laws. Working knowledge of the global regulatory environment. In-depth understanding of the pharmaceutical industry, including IP, manufacturing, R&D, regulatory, and commercial elements.
- Working knowledge of emergency use authorization, expanded access, compassionate use, and foreign regulatory authority equivalents required.
- Strong ability to grasp legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment, and provide practical and constructive legal advice in a time-sensitive, dynamic, and fast-paced complex environment.
- Strong management, teamwork, and leadership skills with a growth mindset, including the ability to effectively work within a matrix team environment.
- Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner. Builds relationships across functions and sites and inspires trust and confidence through effective communication and interpersonal skills.
- Strong work ethic and ability to manage large workload, focus on critical priorities, and otherwise effectively meet client needs directly and with members of the Legal Regulatory and Compliance team.
- Defines success in terms of team goals, adapts quickly to changing resource requirements, has a clear understanding of other groups business priorities, and uses knowledge of organizational culture to achieve objectives.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.