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Regulatory Operations Associate

Job Attributes

Job Id:

21512

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

Not Defined

Business Unit:

Piper Companies

JOB DESCRIPTION

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.    

Requirements:

 

  • 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.

 

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New Search

Job Id:

21512

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

Not Defined

Business Unit:

Piper Companies