Vistakon, a Division of Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Project Manager - Regulatory Submissions.
The Johnson & Johnson Vision Care companies include VISTAKON and VISTAKON Pharmaceuticals, LLC. Transforming the world's vision, 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.
The Project Manager, Regulatory Submissions will manage and compile electronic regulatory submissions utilizing document authoring and management systems and publishing technology to ensure adequate prioritization, preparation and dispatch of submissions that meet Agency requirements. In collaboration with the regulatory project leads, the Project Manager, Regulatory Submissions will create and maintain regulatory submission plans and ensure that submission components meet document and regulatory standards. The Project Manager will provide accurate regulatory operations guidance and information to regulatory leads and submission teams as well as serve as the primary point of contact for electronic documentation and publishing systems within Regulatory Affairs. The Project Manager will develop work instructions, SOPs, and checklists to support regulatory operations and may provide template training.
The Johnson & Johnson Family of Companies has a strong commitment to diversity and welcomes applications for all individuals. EOE M/F/D/V
Qualifications
A minimum of a Bachelor's degree in a health-related science, information technology, life science or relevant technical or scientific field required. A minimum of 3+ years of direct regulatory experience or information management experience in the pharmaceutical, combination products, consumer/OTC, or related industry is required. A minimum of 2+ years in regulatory operations, specifically with electronic submissions (eCTD) is required. Experience in preparing IND/NDA submissions required. Strong project/submission management experience required. Experience with regulatory processes and standards, including publishing software, document standards and templates and Documentum based documentation management systems required. Working knowledge of Agency regulations and industry standards pertaining to regulatory operations required. Software knowledge in Windows, MS Office, Adobe, XML and SML authoring tools, ISI toolbox, Octagon StartingPoint, Docubridge Publishing Tool, and Labeling Management Systems to support Standard Product Labeling is an asset. Experience publishing clinical study reports according to ICH E3standards for use in eCTD is an asset. Knowledge of GMPs, GLPs, GCPs desirable. An experienced user of the FDA electronic gateway is an asset. Familiarity with life cycle management of electronic submissions is an asset. This position will require 25% travel.
If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!
