Founded in 1979, Technical Resources International, Inc. (TRI) is a full-service contract research organization plus (CRO+) providing product development support services to the global drug, biologic, and medical device community through the effective combination of scientific, clinical information technology, and communications services. TRI, Inc. is currently seeking a Regulatory Specialist.
Responsibilities
- Prepare, distribute and track Investigational New Drug applications (INDs)
- Prepare FDA-required IND sponsors’ annual reports
- Prepare scientific and other regulatory documents for submission to the Food and Drug Administration (FDA)
- Attend scientific meetings and review the literature to stay current with new developments in the infectious disease field (in particular, human immunodeficiency virus/HIV and tuberculosis/TB) and therapeutic clinical research
- Prepare investigator/pharmaceutical company meeting minutes
- Perform literature searches and extract information to support regulatory documents
Requirements
- M.S. or Ph.D. or equivalent related experience in pharmacology, toxicology, biochemistry,
- molecular biology, or immunology
- Excellent oral, written and interpersonal skills
- Ability to analyze medical research data and review experimental protocols
- Working knowledge of word processing, spreadsheet and database management programs
Scientific background preferred. Exposure to GCPs and clinical trials are pluses.
Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.
Benefits:
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
- Flexible schedule
- Parental leave
- Professional development assistance
- Tuition reimbursement
Schedule:
Job Type: Full-time
Schedule:
Education:
Location:
- Bethesda, MD 20817 (Required)
Work authorization:
Work Location: In person
