What are the responsibilities and job description for the Regulatory Associate position at Zachary Piper LLC?
Piper Health & Sciences is seeking an entry level Regulatory Associate to join a clinical research company in the Bethesda, MD area. This is an exciting opportunity to gain clinical regulatory experience across multiple therapeutic areas!
Responsibilities for the Regulatory Associate include:
- Prepare standard documentation supporting regulatory filings and distribution to stakeholders.
- Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.
- Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate.
- Draft, edit, and distribute various documents as needed based on templates and work instructions.
- Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, etc.
- Track regulatory activity, maintain, and update databases, and ensure that records are complete and current.
- Provide other administrative regulatory support as needed.
Qualifications for the Regulatory Associate include:
- 0-1 years of clinical research or regulatory experience at a CRO, sponsor, or academic site/institution.
- Familiarity with Good Clinical Practices (GCP) and/or experience of working in an FDA-regulated environment is desirable.
- Proficiency in MS Office (Word, Excel, and Outlook) and experience with SharePoint is preferred.
- Bachelor’s degree in Clinical Research, Regulatory Affairs, Public Health, or related field is required.
Compensation for the Regulatory Associate includes:
- Salary range: approximately $55,000 - $60,000 annually, commensurate with experience
- Comprehensive Benefits: Cigna Medical, Dental, Vision, 401k, STD, LTD, Paid sick leave as required by law, Hybrid working schedule
This job opens for applications on 3/4/2025. Applications will be accepted at least 30 days from the posting date.
Clinical research, clinical trials, oncology, infectious disease, hiv/aids, solid tumor, cancer, regulatory affairs, regulatory operations, reg ops, fda, food and drug administration, ich, gcp, good clinical practices, cro, biotechnology, pharmaceutical, drug development, vaccine development, entry level clinical research
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Job Id:
137500
Job Category:
Clinical Research
Job Location:
Bethesda, MD
Security Clearance:
No Clearance
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Cassandra Parisi
Salary : $55,000 - $60,000
