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 pharmaceutica