Sr. Counsel (Gaithersburg, MD, US, 20879)

Preparedness today, safer tomorrow.

Emergent is a leading public health company that delivers protective and life-saving solutions to
communities around the world. Here, you will join passionate professionals where our culture is informed
by our values and commitment to protecting and saving lives.

I. JOB SUMMARY

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.)

II. ESSENTIAL FUNCTIONS

Reasonable accommodation 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 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
  
  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 management’s 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
• 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. 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 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
• Experience supporting products ex-US highly desirable

U.S. Base Pay Ranges and Benefits Information

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.]

Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here:

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

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.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

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.

Originally posted on Himalayas