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Carrot Peelers, Sales, Personality and Your Job Search
In-House
Attorney
Antitrust and Competition
Litigation - Regulatory Enforcement (SEC, Telecom, Energy, etc.)
Min 5 yrs required
Senior Counsel RESPONSIBILITIES: 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 strategies Provide 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 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.
Qualification and Experience
Qualifications: JD Degree and bar membership and 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. 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. 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.
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