Regulatory Scientist - NIH - Bethesda, MD - Kelly Services

Employer
Kelly Services
Location
Bethesda, MD
Posted
Mar 22, 2019
Closes
Mar 25, 2019
Function
Accountant, IT
Industry
Science
Hours
Full Time
Regulatory Scientist - NIH - Bethesda, MD Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Regulatory Scientist to work onsite with the National Institutes of Health in Bethesda, MD . This is a long-term contract position which offers: - Competitive salary with comprehensive benefit package - Opportunity to work at NIH, the world's foremost medical research center - Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com TASKS. The contractor shall: Serve as a Regulatory Manager for a Gene Therapy project in the National Eye Institute (NEI), Bethesda, Maryland and with The Section for Translational Research on Retinal and Macular Degeneration (STRRMD) at the National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), in Bethesda, Maryland. Collaborate with the Science Program Leader at the NEI on the following tasks: Develop, edit and finalize preclinical GLP and non-GLP reports to serve as documentation for the laboratory and for the FDA and other regulatory bodies. Develop, finalize and document the chemistry, manufacturing and control (CMC) for the manufacturing of the clinical product. This includes, but is not limited to, Develop GLP-compliant study protocols to qualify and validate, as needed, the reagents and /or processes. Interact with manufacturing group in maintaining timeliness and quality of workflow. Provide project management for collaborations; maintain meeting minutes and interactions. Summarize deviations; obtain necessary documentation or tests to address regulatory concerns, either from FDA or other regulatory bodies, DSMC, IRB or other internal groups. Monitor and ensure the training of staff with GMP methods. Review batch records for the clinical product manufacturing prior to drug release. Draft, edit, finalize and proofread of CMC section of Annual report to FDA and to any other relevant regulatory bodies, internal and external. Coordinate the shipping of drug, excipient or other from drug manufacturer to NIH Pharmacy. Collaborate with Pharmacy or other groups in drug preparation and transport. Maintain technical expertise to understand and implement the FDA GMP guidelines. Maintain all the study related documentation in accordance with quality system regulations. Collaborate with Science Program Leader on clinical protocol and consent form navigation and management. Provide protocol and consent form amendments. Collaborate with clinical contract organization to develop timelines and track progress Draft, develop, edit, finalize and proofread specific elements of the protocol and consent form when needed. Develop, draft, edit, finalize and proofread reports on clinical assay results where applicable. Ensure that regulatory documents are submitted in a timely manner, tracked and recorded appropriately. Ensure smooth transition of clinical samples to contract research organization or internal groups for analysis; develop, edit, finalize and proof reports. Maintain clinical and research Manual of Procedures. Collaborate with Science Program Leader on the development of new work scopes; manage external collaborators, timelines, contractual agreements (including but not limited to MTAs, CDA's, and other administrative documentation required for meeting program's objectives) Work with Science Program Leader to keep and maintain meeting minutes and agendas for various working group meetings. Work with Science Program Leader to facilitate good communication throughout all arms of the program on an ongoing basis. REQUIREMENTS. The contractor must have: Ph.D. in Biology or a related discipline; three (3) years of specialized experience plus a Master's degree is equivalent to a Ph.D. Minimum of three (3) years of experience in ophthalmology, physiology; regulatory or FDA experience. Knowledge of FDA-regulatory aspects of IND filing, GMP manufacturing process, and pre-clinical animal safety and efficacy processes. Knowledge of ophthalmology and physiology, preferred. Ability to manage technology transfer documentation, contracts and other agreements. Outstanding writing skills with demonstrated ability to write and submit successful regulatory documents for FDA or other regulatory bodies with attention to detail. Excellent organizational, interpersonal and time management skills. Experience with Microsoft Office Suite (MS Word, PowerPoint, Excel, Outlook), Endnote, and statistical packages including Prizm. PLEASE APPLY ONLINE. Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted. About Kelly Services (R) 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.

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