What are the responsibilities and job description for the Regulatory Operations Associate position at TECHNICAL RESOURCES INT'L?
Job Description:
Job Requirements:
- 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.
Job Requirements:
- Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
- Superior organizational skills and customer service abilities are required.
- Experience publishing regulatory submissions using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred.
- Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.
- Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
- Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable.
- General knowledge of the drug and vaccine development process or clinical trials is a plus.
- This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
Benefits:
401K Plan, Health Insurance, Vacation & Paid Time Off