Regulatory Operations Associate

• 6 month contract to perm -Hybrid schedule (onsite a portion of the time in Bethesda)
• IND management experience required
• Demonstrated experience with databases and database management
• Demonstrated experience maintaining documents
  • Experience with clinical documents is a plus
• Demonstrated experience with the Microsoft office suite

Responsibilities

· 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.

Must have excellent attention to detail; verbal and written communication skills.

· 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.