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Our client, a publicly-traded, biopharmaceutical company with headquarters in Pennsylvania, is seeking a Counsel to join the team. This position will report to the Chief Legal Officer and will be responsible for assisting the Chief Legal Officer with providing advice on regulatory and compliance matters for all Company departments. The Counsel will assist the Chief Legal Officer with the development of the Company compliance policies and processes to ensure that the Company complies with all applicable federal and state laws governing the pharmaceutical industry. The Counsel will also assist the Chief Legal Officer with the drafting of agreements for third party vendor services and goods.
Provides strategic and operational support to Marketing, Legal, Medical Affairs and Clinical Development in the development of advertising and promotion for the US market in accordance with business goals and objectives, FDA regulations, ICH guidelines, PhRMA guidelines and Company policy
Provides solutions-oriented legal advice to senior management and other business stakeholders regarding legal risks associated with the commercialization of company pharmaceutical products
Provides in-depth knowledge of and expert risk advice on federal and state law FDA regulations governing the promotion, marketing and sale of prescription pharmaceutical products
Provides sound legal advice for assigned products that minimizes the risk of regulatory and legal action, competitively positions assigned products and is consistent with applicable FDA regulations and policies for advertising and promotion of prescription drug products
Provides comprehensive legal support to multiple business units in order to identify, manage and help mitigate legal risks including those that involve fraud and abuse, anti-kickback and anti-trust laws
Advises Company management on press releases, publication activities, market research and development of promotional strategies and claims to ensure compliance with applicable laws
Coordinates legal, regulatory and compliance matters handled by outside counsel
Drafts, reviews and negotiates a variety of contracts including master service agreements, consulting agreements, distribution, managed care and market research agreements
Collaborates with US and Global colleagues in order to ensure business strategies and objectives comply with applicable laws, regulations and policies
Serves as one of the legal representatives on approval process review team to ensure compliance of sales and marketing activities with applicable laws, regulations and company policies in order to support successful promotional practices
Reviews and approves advertising/promotion materials and labels and other content for Medial Affairs department
Provides legal advice regarding compliance with transparency reporting obligations (Federal Sunshine Act and state/other transparency reporting requirements)
Assists Chief Legal Officer with the development and implementation of internal compliance policies and procedures and monitors compliance with FDA regulations governing the Company’s pharmaceutical products and business
Reviews clinical research and protocols and informed consents for compliance with the GCP/ICH and other applicable guidances
Assists Chief Legal Officer with internal compliance review to assess anti-bribery and corruption risks in foreign markets
Develops and delivers training to sales and marketing personnel on laws, regulations and policies related to the promotion and sale of Company’s pharmaceutical products
Represents the legal department on various committees and teams
Handle such other legal matters as may be assigned by Chief Legal Officer
at least 5-8+ years’ experience working as an attorney in a legal department for pharmaceutical or biotech companies
In-depth knowledge of statues, regulations and guidance documents applicable to commercial operations and Medical Affairs activities, including research and interpretation of FDA regulations and other legal documents related to the Food, Drug and Cosmetic Act, federal and state anti-kickbcak statues, regulations and OIG guidance documents and opinions; the federal False Claims Act; Health Insurance Portability and Accountability Act (HIPAA); Physician Payment Sunshine Act; PhRMA Code and related policies and guidelines
Experience serving on a Promotional Review Committee highly desired
Experience supporting sales and marketing with advertising, promotion and labeling issues
Experience providing legal advice for a wide range of regulatory matters, including FDA and OIG regulations
Experience drafting and negotiating commercial contracts for the pharmaceutical industry
Experience advising company management regarding programs and policies
Proven ability to think strategically about achieving corporate objectives by addressing the regulatory and compliance needs of internal and external constituencies
Demonstrated track record in achieving the legal department objectives, especially in the creation and development of policies and processes that adhere to FDA laws and regulations
Excellent interpersonal, analytical, drafting and communication skills
Proven ability to build relationships with third party providers of goods and services
Proven ability to build relationships and collaborate with internal constituencies, such as Clinical Development, Marketing and Sales to achieve corporate objectives
Princeton Legal Search Group, the most trusted name in legal executive search, specializes in the placement of General Counsel level candidates and other exceptionally qualified attorneys with in house legal departments across a wide range of industries throughout the United States. We place attorneys in full time positions in all practice areas. We have offices in Princeton, New Jersey and Woodbr...idge, New Jersey and additional offices are planned.
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