Documentation Specialist

2 days ago


Rahway, New Jersey, United States eTeam Full time
Job Title: Documentation Specialist

Join eTeam as a Documentation Specialist and take on a challenging role that requires expertise in procedural documentation management and strategy. As a key member of our team, you will support the operational aspects of documentation management and advise on documentation strategy for our client's Global Regulatory Affairs & Clinical Safety organization.

Key Responsibilities:
  • Support the development, revision, implementation, and maintenance of procedural documentation, including policies, standard operating procedures, and supporting documents.
  • Collaborate with Business Process Leads, Functional Leads, Document Owners, and Subject Matter Experts to ensure documentation conforms to MRL standards and reflects intended processes.
  • Manage the creation and revision of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation, including Standard Operating Procedures, Job Aids, Forms, Process Guides, and User Manuals.
  • Develop and manage integrated project plans, lead documentation impact assessments, and support process owners in developing process maps.
  • Maintain and organize current effective documentation within logical groupings/categories to facilitate ease of access for GRACS end users.
  • Support and manage requests for documentation for GRACS internal audits and inspections.
Requirements:
  • 6+ years of industry experience and familiarity with Regulatory Affairs and Global Pharmacovigilance Procedural Documentation.
  • Bachelor's degree or higher.
  • Veeva Vault Quality Docs experience preferred.
Work Arrangements:

3 days onsite required. Candidate can be local Upper Gwynedd, PA location & or Rahway, NJ.



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