GDIT's Military Health team is hiring a Regulatory Affairs Scientist to support the Office of Regulated Activities (ORA), United States Army Medical Research and Development Command (USAMRDC) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products.The Regulatory Affairs Scientist will ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy, to include identifying and mitigating risk, and provide support to integrated project teams and working groups.RESPONSIBILITIES:
Provide subject matter expertise on all regulatory matters related to assigned regulatory projects; ensure ORA leadership and the sponsor’s representative are kept current on the progress of the program through periodic reports
Provide regulatory support to an integrated product team or working group, which includes working with the team members, advising the team of any FDA-related activities and issues, and attending meetings, updating ORA leadership and the sponsor’s representative through routine reports
Lead the development of a written regulatory strategy and provide to the Government. The strategy shall describe the regulatory pathway for FDA regulatory approval/licensure/clearance, any possible post-marketing commitments, and shall also describe the target product profile or equivalent that can be used throughout the development process that will describe how a product will be utilized by the end user and provide to the Government.
Create and maintain Target Product Profiles and provide to the Government. The target product profiles shall contain the indication and usage, dosage and administration, dose forms and strengths, contraindications, warning and precautions, safety adverse reactions and drug interactions, use in specific populations, drug abuse and dependence/overdose, description of drug, clinical/pharmaceutical, pre-clinical toxicology, clinical studies, references, storage and handling, patient counseling, risk evaluation mitigation strategy, and supporting documentation and/or templates as appropriate.
Identify and mitigate regulatory risk through a project Risk Register
Serve as the primary contact with the FDA; review, analyze, and respond to FDA communications and meetings by the regulatory deadline
Lead the development, organization, and structure of regulatory submissions, regulatory correspondence, and meeting minutes in EDMS
Coordinate, prepare, write, review, obtain, maintain, and archive the required documents for regulatory submissions in EDMS
Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities
Confirm the need for registration, based on regulation and Army policy, and provide regulatory support for data entry and quality assurance of ClinicalTrials.gov information/entries, a Web-based resource that provides information on publicly and privately supported clinical studies on a wide range of diseases and conditions
Review and provide written critical regulatory feedback on acquisition milestone decision briefings, progress reviews, and other acquisition documents
Write, review, and/or revise standard operating procedures (SOPs)
Bachelor’s Degree or the equivalent combination of education, professional training, or work experience. MS in regulatory affairs is preferred.
5 years of related experience.
Experience working and communicating with the FDA is highly preferred.
Experience developing regulatory strategies for diverse medical products
Experience preparing electronic common technical document format (eCTD) regulatory submissions is highly preferred.
Regulatory Affairs Certification (RAC) is preferred
Must be highly organized, detail oriented, and perform independently.
Have excellent Microsoft Word, Teams, and Excel Spreadsheet skills.
Excellent written and oral communication skills.
Must be U.S. citizen and be able to obtain a TI (Public Trust).
Some travel may be required.
WHAT GDIT CAN OFFER YOU:
Challenging work that makes a real impact on the world around you
Internal mobility team dedicated to helping you own your career
401K with company match
Diverse, highly collaborative teams
Professional development, education assistance, certification and training opportunities
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.