高级律师（Gaithersburg, MD, US, 20879）
Sr. Counsel (Gaithersburg, MD, US, 20879)
保障今日，守护明天。
Emergent 是一家领先的公共卫生公司，为全球社区提供保护性及挽救生命的解决方案。在这里，你将加入充满热情的专业人士团队，我们的文化由价值观和对保护与拯救生命的承诺所驱动。
一、职位概述
Emergent 正在寻找一位高级法律顾问（商业方向）加入不断壮大的法务团队。该职位是一个令人兴奋的机会，加入一个快节奏、动态的法务部门，支持商业组织的各个方面。成功候选人将通过提供实用、及时、战略性和高质量的法律建议，为组织内广泛的客户群体提供复杂美国及全球法律、监管和合规事项的支持。重点是就与联邦贸易委员会（FTC）指南、欺诈与滥用、反回扣、美国食品药品监督管理局（FDA）、监察长办公室（OIG）指南、产品责任问题、隐私、声誉风险以及各种州和联邦法律（如虚假索赔法案、阳光法案、CAN-SPAM、TCPA 等）相关的风险提供建议。
二、核心职责
将为有残疾的个人提供合理的便利，以使其能够履行核心职责。
- 与监管和医疗合作伙伴协作，为营销、销售、医学和培训资料的宣传审核提供以解决方案为导向的法律建议。
- 为商业业务团队提供战略性的法律建议和主动的解决方案。
- 为公司业务单元提供法律支持，就遵守适用的联邦和州医疗法规、规章和行业标准（如 FDCA、AKS、PhRMA 规则）向内部利益相关者提供建议。
- 就非市场和销售职能的内部和外部沟通提供建议。
- 就与销售和营销、市场准入、患者倡导、患者服务、医学信息、按服务收费安排、药品定价、数据隐私计划、社交媒体、使用代言人和/或名人、药品标签、战略计划和策略、竞争问题以及与非营利组织的互动相关的问题提供实用且及时的法律指导。
- 支持政府事务工作，并在需要时与外部律师协调处理政府事务相关事宜。
- 代表法务部门参与各种跨职能委员会和团队。
- 与法律、监管和合规同事合作，提供指导。
查看英文原文
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