Project Manager, Regulatory Labeling - (Job Number: 0800197)

US-FL-Gainesville/Jacksonville/Ocala Status: Full Time, Employee Job Category: Biotech/R&D/Science Reference Code: 695914 Project Manager, Regulatory Labeling - (Job Number: 0800197) DescriptionVISTAKON, a division of Johnson & Johnson Vision Care, Inc. is seeking a Project Manager Regulatory Labeling located in Jacksonville, Florida. VISTAKON, a division of Johnson & Johnson Vision Care, Inc. manufactures ACUVUE brand contact lenses'the world's first soft disposable contact lens. Headquartered in Jacksonville, Florida, VISTAKON, a division of Johnson & Johnson Vision Care, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, no other manufacturer has matched the aggressive expansion of our wide-ranging ACUVUE family of products. Our associates around the world are committed to expanding the ACUVUE brand, and fortifying our position as the worldwide leader in the contact lens industry. To assist us with the growth of our contact lens business, we are seeking a Project Manager, Regulatory Labeling to:Be responsible for the management of regulatory activities in the support of external commercial communications, labeling development and labeling maintenance. Represent regulatory on cross functional teams that review and/or approve promotional materials, sales training materials, presentation materials created by sales personnel, press materials and other external communications. Act as liaison with regulatory authorities in matters relating to labeling and promotions. Review and approve labels and labeling for conformance to regulations and to commitments made in pre-market applications. Review and approve promotional materials, advertising and sales materials for conformance with regulations and verification of appropriate support of claims. Develop, with continuous improvement, processes for identifying, establishing, and maintaining requirements for as well as procedures for handling labeling and promotional materials. Ensure regulatory affairs teams are aligned on processes and requirements. Work closely with global strategic marketing, US Marketing and the packaging and labeling development group on prioritizing of labeling and promotional materials to meet company needs. We are dedicated to serving the needs of our customers by bringing healthy vision to everyone, everywhere, every day. To this end, we are focused on developing leaders with a broad base of business and cultural skills, along with a strong commitment to the values that are expressed in Our Credo. A minimum of a Bachelors degree is required (Scientific discipline preferred). A minimum 6 years of working experience within the Pharmaceutical or Medical Device Regulatory environment and a minimum of 2 years experience in Regulatory Submissions. Strong communication, organizational, negotiation and interpersonal skills. General knowledge, understanding and application of principles, concepts and practices of government regulations. Regulatory or clinical knowledge to maintain legal status of products and minimize risk. Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, marketing, etc.). Ability to organize and analyze data and identify issues or gaps. Ability to provide innovative solutions within the boundaries of Regulation. If you're an achiever eager to reach your highest potential, you'll appreciate how Johnson & Johnson Vision Care helps you define and pursue a career path that matches your abilities, experience and desire to achieve. Whether you're an experienced professional or just beginning your career, think about the benefits of building your future with a company that offers a breadth of opportunities across business segments and worldwide regions. Come see why we have earned a reputation for being an innovative market leader and why Johnson & Johnson is the employer of choice. Apply Now