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15 days old

Regulatory Submission Manager - Cincinnati, OH

Kelly Services
Cincinnati, OH 45217
**Kelly LifeScience & Clinical is currently looking to hire a** **Regulatory Submission Manager** **for a Direct-Hire opportunity at one of our clinical contract research organizations (CRO) customers out of Cincinnati, OH**




**Responsibilities:**


**Fully accountable for the success of project start-up.**


**Efficiently manage and successfully execute all aspects of global start-up according to Sponsor specifications, including maintaining start-up timelines**


**Maintain ongoing Sponsor contact for submission issues by serving as primary contact for Sponsor and project team members**


**Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs), regulatory agencies, and the team**


**Provide regulatory submissions advice and guidance to the team to ensure compliance with appropriate regulations and requirements**


**Quality check of submission documents**


**Present during bid defenses, general capabilities meetings, and audits**


**Provide oversight of Regulatory Submissions Coordinators and Clinical Trial Assistants**


**Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.**




**Minimum qualifications:**


**Bachelors degree and 4 years of clinical operations/study start-up experience; or masters/PhD degree within life sciences and at least 3 years of clinical operations/study start-up experience**


**Writing regulatory submissions**


**ICF writing is nice to have, but not required**



**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS

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Posted: 2020-10-05 Expires: 2020-11-16

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Regulatory Submission Manager - Cincinnati, OH

Kelly Services
Cincinnati, OH 45217

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