Documentation Specialist

3 weeks ago


Rahway, New Jersey, United States AA2IT Full time
Job Summary:

We are seeking a highly skilled Documentation Specialist to join our team at AA2IT. The successful candidate will be responsible for supporting the development, revision, and maintenance of procedural documentation related to global Regulatory Affairs and Pharmacovigilance activities.

Key Responsibilities:
  • Support the creation and revision of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation.
  • Develop and manage integrated project plans to identify the impact of process changes across the library of documents.
  • Facilitate documents through draft, review, and approval cycles to meet required timeframes for release and implementation.
  • Maintain and organize current effective documentation within logical groupings to facilitate ease of access for end users.
  • Support requests for documentation for internal audits and inspections.

Requirements:
  • 6+ years of experience in Regulatory Affairs and Global Pharmacovigilance Procedural Documentation.
  • Experience in leading and/or completing documentation impact assessments.
  • Experience in development, revision, implementation, and maintenance of procedural documentation.
  • Veeva Vault Quality Docs experience preferred.

Additional Information:
  • 3 days onsite required.
  • Candidate can be local Upper Gwynedd, PA location or Rahway, NJ.


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