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 opthalmic 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.
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:
EU CE Mark and/or Medical Device Regulation standards
Anti-bribery or anti-kickback considerations
Implementation of global compliance codes
Basic transactional or litigation matters, particularly competitive disputes (Lanham Act litigation, NAD challenges)
Drafting and negotiation of clinical trial transnational documents (e.g., clinical research agreements, CRO vendor agreements, specialized consulting agreements)
Drafting and negotiation of clinical trial transactional documents (e.g., clinical research agreements, CRO vendor agreements, specialized consulting agreements)
Alcon's leadership is grounded in cutting-edge innovation and breakthrough technology, transforming the way we treat eye diseases and conditions. We offer a broad spectrum of eye care products and are organized into three businesses: Surgical, Pharmaceutical and Vision Care.
Alcon has one mission: to provide innovative products that enhance quality of life by helping people see better. The merg...er with Novartis (link is external) in 2011 helped us do this by uniting the strengths of Alcon, CIBA VISION and Novartis Ophthalmics into one Alcon eye care business, which is now the second-largest division of Novartis. This enables us to serve our customers through the full life cycle of patient needs across eye diseases, vision conditions and refractive errors.