Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.
We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!
MSC is currently searching for a Regulatory Affairs Specialist to support the National Institutes of Health (NIH). This opportunity is full-time, and it is on site in Bethesda, MD
Duties and Responsibilities:
Provide support and guidance with regards to IND/IDE/FDA/Regulatory Agency submissions
Provide assistance for IND/IDE submissions to the FDA
Serve as a liaison for clinical investigators and other clinical regulatory staff providing regulatory guidance, review and expertise to ensure documentation conforms to applicable regulations and guidelines
Assists in the collection and review of study-specific documentation for each protocols submitted under an IND/IDE
Compile and maintain IND/IDE Sponsor regulator files (digital and hard-copy) throughout the lifecycle of sponsorship
Coordinate activities pertaining to the compilation and submission of original INDS for management and multi-disciplinary team review
Provide technical expertise for the development of regulatory strategies in the preparation, submission and approval of IND and IDE documents/submissions to the FDA as describes in 21 CFR 312 and 21 CFR 812
Compile, review and submit documentation for amendments, supplements, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs, IDEs and Drug Master Files.
Review adverse event reports; prepare safety reports, protocol and information amendment and annual reports for submission to the FDA
Assist with preparation for FDA audits
Ensure incoming and historical documents are organized and filed appropriately and the Investigator and Sponsor’s regulatory record is complete in compliance with FDA regulations, guidance, policies and procedures
Participate in interactions with regulatory agencies on defined matter
Provide regulatory guidance to clinical investigators and other clinical staff.
Bachelor's degree, Master's preferred.
Expert knowledge of Federal laws, regulations and agency policies and procedures relating the conduct of clinical trials regulated by the FDA.
At least 3 years’ experience managing and supporting regulatory documentation for clinical trials
Experience with biologics and cell therapeutics a plus
Demonstrated strong writing skills and ability to work in a flexible environments.
Strong client interaction skills
Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.
Medical Science & Computing, Inc. (MSC) is a small business focused on providing technical and scientific services to the Federal Government. Our staff has a long history of supporting the National Institutes of Health (NIH), as well as other Federal agencies such as the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Department of Defense (DoD).