Sr. Counsel (remote)

Emergent Biosolutions

2d•$206,500 - $250,000•Remote

About The Position

Emergent is looking for a Senior 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. 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.).

Requirements

Law Degree from an ABA accredited school and licensed and in good standing in at least one U.S. State
Licensed to practice law in at least one state and in good standing
A minimum of 5-7 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.
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.
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 teams
Strong oral, written and presentation skills and ability to clearly articulate complex information
Strong analytical and problem-solving skills, with attention to detail
Ability to establish and maintain effective working relationships throughout the organization

Nice To Haves

Experience working in a matrix environment is a plus.
Experience supporting products ex-US highly desirable

Responsibilities

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 legal support to Company business units advising internal stakeholders on compliance with applicable federal and state healthcare laws, regulations and industry standards (e.g., FDCA, AKS, PhRMA Code).
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.
Support Government Affairs and coordinate with external counsel on GA matters when needed.
Represent Legal on various cross-functional committees and teams.
Collaborate with legal, regulatory, and compliance colleagues in providing guidance and input on a broad range of complex agreements.
Provide support for regulatory, medical affairs and product development teams, including legal interpretation of laws, regulations, and guidance documents related to the development and commercialization of pharmaceutical and biopharmaceutical products.
Provide education and training of business and cross functional stakeholders on commercial best practices and policies.
Actively participate in department initiatives, identifying opportunities to enhance the effectiveness of Legal department operations.
Assist with internal policies, training, and corporate governance initiatives
Participate in business development activities (merger and acquisitions, licensing and other partnering opportunities), including deal and risk assessment and due diligence
Other duties as assigned