We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I. JOB SUMMARY
Remote Work Eligible – Emergent is looking for an Assistant General Counsel - Commercial to join its growing Legal team. The position is an exciting opportunity to join a fast-paced, dynamic legal department supporting all aspects of the commercial organization with a focus on Over the Counter (OTC) NARCAN® Nasal Spray. The successful candidate will provide legal support for a breadth of complex US and global legal, regulatory and compliance matters by providing practical, timely, strategic, and high-quality legal advice to a broad spectrum of clients across the organization. Focus is on counseling regarding risks related to Federal Trade Commission (FTC) guidance, fraud and abuse, anti-kickback, US Food and Drug Administration (FDA), Office of Inspector General (OIG) guidance, product liability issues, privacy, reputational risk, and various state and federal laws (e.g., False Claims Act, Sunshine Act, CAN-SPM, TCPA, etc.)
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform essential functions.
• Provide solutions oriented legal advice in the promotional review of marketing, sales, medical, and training assets in conjunction with regulatory and medical partners.
• Provide strategic legal advice and proactive solutions to commercial business teams.
• Provide advice on internal and external communications by non-marketing and sales functions.
• Provide practical and timely legal guidance on issues related to sales and marketing, market access, patient advocacy, patient services, medical information, fee-for-service arrangements, drug pricing, data privacy initiatives, social media, use of endorsers and/or celebrities, drug labeling, strategic plans and tactics, competitive issues, and interactions with nonprofits.
• Represent Legal on various cross-functional committees and teams.
• Collaborate 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.
• Provide 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.
• Provide education and training of business and cross functional stakeholders on commercial practices and policies.
• Actively participate in department initiatives, identifying opportunities to enhance the effectiveness of Legal department operations.
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 management’s 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
• A minimum of 7 years of experience working in a law firm and/or pharmaceutical or biotechnology legal department, with at least 2+ years in-house experience in the biotech and/or pharmaceutical industry
• Understanding of the legal issues affecting the pharmaceutical industry, including regulatory processes and guidance for prescription and OTC 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 preferred.
• 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 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. Experience working in a matrix environment is a plus.
• Ability to work independently and take initiative to drive forward priorities, complete tasks and appropriately manage risks.
• 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.
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
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.