We are currently seeking an experienced attorney focused in the area of pharmaceutical, regulatory, and health care compliance to support the growth of Emergent’s travel health vaccine program. This position will report to the Assistant General Counsel, Commercial and will be responsible for providing strategic legal advice and guidance in support of the labeling, promotion, and distribution of Emergent’s travel vaccine products in the United States and other markets.
-Maintain a current working knowledge of the various laws, regulations, and industry guidance relevant to the compliant commercialization of pharmaceutical products. This includes the Federal Anti-kickback Statute, False Claims Act, Food Drug and Cosmetics Act, the OIG and DOJ guidelines, PhRMA Code, US state and local marketing compliance laws and recent government enforcement actions.
-Utilize knowledge to advise on and assist in the review of promotional materials, product labeling, and regulatory submissions
-Lead and assist, with a focus on regulatory compliance, on the company’s traveler vaccine marketing plans and strategiesProvide legal advice and assist on operational contracts as required and in particular on those related to areas of responsibility
-Establish strong relationships and serve as a business partner to the key internal stakeholders responsible for Emergent’s commercial efforts, including for example Commercial, Marketing, Regulatory, and Medical Affairs
-Draft, advise on, and implement policies and procedures related to area of responsibility to address emerging risk areas and business needs
-Working with Commercial and the Ethics and Compliance Office, develop and deliver impactful training to key stakeholders (Sales and Marketing, Medical Affairs and the associated field-based staff) in a manner that ensures understanding and applicability of requirements
-Provide legal support and guidance on the company-wide privacy program. Serve as a trusted resource for privacy related matters and maintain a working knowledge of GDPR as well as the relevant privacy laws in the US and Canada
-The above statements are intended to describe the general nature of work performed in this position. It is not an exhaustive list of all duties, and other duties may be assigned.
Education and Experience:
J.D. and bar membership and minimum of 5 years of relevant legal experience required.
United States biopharmaceutical industry experience required, whether through in-house experience or law firm client base. European and/or Canadian experience is desirable.
Skills and Personal Attributes
-A team player who works collaboratively with colleagues across the organization:
By developing relationships with co-workers with a different perspective and supporting peers as applicable
By leading teams on specific matters to achieve specific initiatives
By being a trusted advisor
By having an awareness of external perceptions of strengths and weaknesses
By using strong presentation skills
-An attorney with an honest appreciation of his or her own capabilities:
Who has excellent analysis and decision-making skills in areas of expertise
Facilitates decision-making with a solutions-oriented mindset
With substantial legal knowledge and experience in primary disciplines
Who produces work product of a high standard with limited supervision
-A leader who:
Understands how the group fits in with/can impact strategic initiatives of the corporation and responds flexibly to associated change
Provides strategic advice to the group and the corporation
Implements knowledge-sharing initiatives to leverage group expertise
Effectively receives and communicates difficult messages
Exemplifies Emergent’s core values of respect, commitment, empowerment, communication and innovation
Type/keyboard. Use phone, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transactions
Protecting and Enhancing 50 million lives by 2025 focuses our energy to improve the quality of life for millions of individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.