Dir Sr Legal Counsel Reg & Dev Law

This position will be responsible for providing food and drug law-related legal support on regulatory issues relating the approval, manufacturing and marketing of Alcon's products, including providing legal input on promotional materials relating to an assigned portfolio of medical devices. The position is expected to focus primarily on Alcon's ophthalmic surgical portfolio, but may also present opportunities to provide input on matters relating to Alcon's consumer-oriented contact lens and lens care business. The successful candidate will have frequent interactions with senior managers in Alcon's commercial, regulatory, and quality functions.

Key responsibilities include:

  • As assigned, serve as the primary point of contact for advertising-related issues for multiple high-profile Alcon products or initiatives, including:
  • -- reviewing and approving promotional materials and product labeling for specific Alcon products; and
  • -- coordinating legal support for advertising challenges with the potential for significant business impact, including management and oversight of outside counsel.
  • Provide input on clinical studies intended to support proposed product and/or indication launches
  • Identify and interact with counterparts in other Novartis affiliates to level-set and ensure consistency of approach.
  • Manage outside counsel to ensure that Alcon receives timely, efficient and effective legal advice and representation; and that legal fees and expenses are reasonable for the services provided.

Desirable knowledge and skills:

  • Comprehensive knowledge of FDA and FTC standards relating to the approval, manufacturing, and promotion of medical devices
  • Prior experience advising pharmaceutical, medical device, or consumer product companies one or more of the following areas is also preferred:

o EU CE Mark and/or Medical Device Regulation standards;

o anti-bribery or anti-kickback considerations (e.g., FCPA or FCA);

o implementation of global compliance codes (e.g., the AdvaMed and EucoMed codes);

o basic transactional or litigation matters, particularly competitive disputes (Lanham Act litigation, NAD challenges);

o drafting and negotiation of clinical trial transactional documents (e.g., clinical research agreements, CRO vendor agreements, specialized consulting agreements); and

o advising on medical device reimbursement matters.

Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements • 6+ years of relevant prior legal experience is required

  • Must possess a law degree and a license to practice law in a relevant jurisdiction
  • English fluency is required; fluency in other languages is a plus
  • Significant prior expertise advising medical device manufacturers on regulatory and quality issues in a law firm or in-house setting is strongly desired
  • Prior scientific or technical training is a plus

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