Regulatory Submissions Project Leader Job in Jacksonville, Florida US
VISTAKON®, a member of the Johnson Johnson Family of Companies, is recruiting for a Regulatory Submissions Project Leader, located 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.
The Regulatory Submissions Project Leader is responsible for leading electronic publishing and production of regulatory submissions that conform to regional (ICH) and country specific regulatory requirements. The range of submission types the incumbent may publish will depend on demonstrated technical skills and competencies and will include, but not limited to, periodic submissions CTA, IND, MAA Variation, sNDA/sBLA (low-to-high complexity), labeling submissions and response to agency queries. The incumbent will play a leadership role on a team document specialists (Lead Specialist - Specialist level) and production contractors based Johnson and Johnson corporate infrastructure (several different sites) and will be accountable for ensuring that regulatory submissions of all types, formats and complexities are generated consistent with business priorities and regulatory requirements. This individual will assist in leading the training and development of subordinates in the application of technologies and tools to support submission publishing and be accountable for the quality and timeliness of submission publishing output consistent with applicable standards and requirements. The Regulatory Submissions Project Leader will serve as a liaison between the business (JJ) represented by either Regulatory Submission Services or Regulatory Affairs and the non-JJ service provider. This individual will also routinely review performance standards as part of the established contract and Service Level Agreement to identify opportunities to enhance overall performance as measured by cycle-time, quality indicators and other performance metrics as defined. This individual will serve a critical role in technology, process improvement and other operational initiatives that are related to or interface with the regulatory submission processes/systems.
Qualifications
A minimum of a Bachelors degree is required. A minimum of 5 years of relevant experience in a highly regulated industry is required. A minimum of 3 years in a Regulatory role is required. A focused degree in Technical, Business Management or Scientific discipline is preferred. Experience in Regulatory Operations/Regulatory Affairs, project management, or finance is preferred. General working knowledge of Documentum, Adobe, CoreDossier, ISI Toolbox, Datafarm and/or related publishing tools is preferred. Experience and/or knowledge of CTD/eCTD building is preferred. Publishing and Regulatory Operations experience is preferred. Experience managing projects is required.
Exceptional interpersonal and teamwork skills are required. The incumbent must be able to work effectively in a highly-matrixed environment, possess strong leadership and be able to work across organizational boundaries with a varying degree of independence. The ability to effectively collaborate in a team environment and strong communication, oral, written and listening skills are required. The ability to manage multiple priorities simultaneously is required. Strong influencing and negotiating skills are required.
This position will be based in Jacksonville, Florida and may require up to 5% travel.
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