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Regulatory Affairs Specialist

Company: Kelly Services
Location: Jacksonville
Posted on: July 15, 2019

Job Description:

Kelly Services' Outsourcing & Consulting Group (OCG) is seeking a Regulatory Affairs Specialist for a long-term, open-ended assignment in Jacksonville, FL and offer benefits (see below). The Regulatory Specialist is a key documentation expert for the Regulatory Affairs department and is responsible for preparation of internal regulatory documentation and various document types to be used in dossiers and labeling, both in paper and electronic formats. RESPONSIBILITIES: Prepares, dispatches and files routine Regulatory Affairs documentation, including but not limited to 30-day Notices, DTF, HA correspondence in paper and electronic format. Prepares high quality submissions and labeling by editing and formatting documents while adhering to current regulatory guidelines, internal processes and procedures, style and document standards and utilizing Vistakon publishing tools, technology and systems. Performs routine operational tasks including but not limited to publishing, archiving and uploading of documents to document management systems. Collects required documents, scans, etc. to complete routine submission packages. Organizes electronic structures for local storage of regulatory submissions and/or labeling in accordance with internal procedures. Maintains document design consistency for all documents to ensure compliance with company document design standards, including the use of predetermined templates. Participates in other key regulatory projects including but not limited to external environment monitoring JOB FUNCTION: Performs final formatting and appropriate rendering of documents for filing and submission, including version control and document handling, to maintain regulatory compliance. Follows established standard operating procedures. Assists with the monthly reporting of data for established metrics. Meets personnel paperwork due dates, e.g., timesheets. Stays current with changes of internal procedures. Interacts with employees in a collegial and professional manner. Remains current with all assigned training. QUALIFICATIONS: Associate or Bachelor degree with 1 year of experience in regulatory affairs; or high school diploma or general education degree (GED) with 1 to 2 years related experience; and/or training or equivalent combination of education and experience. Ability to perform most duties under direct supervision Good organizational skills, accuracy and attention to detail Ability to complete assigned tasks efficiently with direction A team player who is able to work in a fast-paced environment. Software knowledge: Windows, MS Office (intermediate skills required), Adobe Acrobat Professional Good verbal and written communications If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration! This position comes with enhanced benefits which include: 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)* Paid holidays Paid sick days and vacation days* Perks of being a Kelly employee: Weekly electronic pay Access to more than 3,000 online training courses though Kelly Learning center Online application system Never an applicant fee *benefits to be received upon meeting eligibility requirements Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.Why Kelly--? The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG--) is one focus within the full array of Kelly Services-- workforce solutions. Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs. About Kelly Services-- As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter. Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

Keywords: Kelly Services, Jacksonville , Regulatory Affairs Specialist, Other , Jacksonville, Florida

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