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!
Duties & Responsibilities
Medical Science & Computing is searching for a Senior Regulatory Affairs Scientist to provide support to the National Institutes of Health (NIH). This opportunity is full-time with MSC and it is on-site in Bethesda, Maryland.
- Serve as a regulatory affairs management expert. Responsible for managing an Investigational New Drug (IND) application portfolio of products consisting of vaccines and monoclonal antibodies for compliance with the Food and Drug Administration (FDA) regulations for use of investigational products in humans.
- Serve as an authoritative expert on all regulatory matters concerning the development of vaccines and monoclonal antibodies. This involves strategy, implementation, review processes, submissions and compliance with the FDA, National Institutes of Health (NIH) and international regulatory authority regulations.
- Provide recommendations to the office Director on optimal strategies to advance candidate products to the clinic.
- Write and review documentation for compliance with FDA current Good Clinical Practice (cGCP), Good Laboratory Practice (GLP), and/or current Good Manufacturing Practice (cGMP). These documents include, but are not limited to, clinical study protocols, informed consent documents, case report forms (CRFs) to ensure test plans encompass all required test elements, data parameters, test objectives, chemistry manufacturing and control (CMC) documents, and nonclinical study report summaries.
- Responsible for the management and quality of the Investigational New Drug (IND) application and amendments throughout it’s lifecycle which includes writing, reviewing and/or editing the initial IND submission, IND amendments, Investigator Brochures and FDA annual reports.
- Interact with FDA project managers routinely. Responsible for pre-pre and pre-IND meetings and meeting packages, and responses to FDA queries.
- Prepare detailed reporting to the Director to ensure Sponsor responsibilities are met. This reporting includes but is not limited to the development of adequate clinical monitoring plans, adherence to the study protocol, product accountability, safety of human subjects, validity of data, and compliance with regulatory requirements.
- Develop standard operating procedures, evaluate emerging regulations and changing regulatory landscape for impacts, provide strategic advice, and communicate with stakeholders which may include recommending applicable education and training to personnel for assurance of regulatory compliance.
- Serve as liaison between the Office and other components involved in product development. Serve on product development teams as the regulatory expert.
- Master’s degree or Ph.D. in a Health Science discipline, Regulatory Affairs, or related field.
- Minimum of 3 to 5 years of experience managing INDs.
- RAC certification, beneficial.
- Skills required include both extensive theoretical and practical knowledge in the application of Title 21 Code of Federal Regulations (CFR) (GCPs, GLPs, GMPs) to ensure FDA regulatory compliance,
- Highly developed communication and negotiating skills.
- Knowledge of the scientific basis, manufacturing, preclinical studies, and clinical studies of the product.
- Knowledge of all relevant international, national and local regulations.
- Experience in eCTD submissions is highly desired.
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.
Electronic Common Technical Document
Coherent Remote File System (Crfs)
Good Clinical Practices (Gcp)
Case Report Forms
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