[Hiring] Senior Counsel @Emergent Biosolutions

Role Description

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
• Various state and federal laws (e.g., False Claims Act, Sunshine Act, CAN-SPM, TCPA, etc.)

Qualifications

• 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
• 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 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 effectively meet client needs
• 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
• Experience supporting products ex-US highly desirable

Requirements

• 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

Benefits

• The estimated annual base salary as a new hire for this position ranges from $206,500 to $250,000
• Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data
• The salary may also be adjusted based on applicant’s geographic location
• Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options
• Emergent offers a comprehensive benefits package