Job Description

Job Description

Job Description

Position: Clinical Documentation Specialist
Department: Regulatory Affairs & Pharmacovigilance
Location: Rahway, NJ (with option to be local to Upper Gwynedd, PA)
Duration: 2 months
Additional: 3 days onsite required.

Job Description:

The Documentation Specialist - III (Senior) will support the operational aspects of procedural documentation management and advise on documentation strategy within the Global Regulatory Affairs & Clinical Safety (GRACS) organization. This role involves supporting GRACS Document Owners and Functional Areas in the development, revision, implementation, and maintenance of procedural documentation, including policies, standard operating procedures (SOPs), and supporting documents related to global Regulatory Affairs and/or Pharmacovigilance activities.

Key Responsibilities:

• Support and manage the creation and revision of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation (e.g., SOPs, Job Aids, Forms, Process Guides, User Manuals).
• Develop and manage integrated project plans, lead or complete documentation impact assessments to identify the impact of process changes across the document library.
• Assist process owners in the development of process maps to support procedural documentation development.
• Facilitate documents through draft, review, and approval cycles to meet required timeframes for release and implementation.
• Conduct periodic assessments of procedural content to ensure adherence to format, content, and style guidelines, and identify improvement opportunities for Process Owners and Document Owners.
• Support and manage the overall documentation change control process and related systems for document access, review, and approval.
• 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 during internal audits and inspections for process documentation.
• Experience with Veeva Vault Quality Docs is preferred.

Qualifications:

• Education: Bachelor’s degree or higher required.
• Experience: Minimum of 6 years of industry experience, with familiarity in the following areas:
  • Support and management of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation.
  • Development and management of integrated project plans.
  • Facilitation of documents through various approval cycles.
  • Conducting periodic content assessments and identifying improvement opportunities.
  • Managing documentation change control processes and systems.
• Preferred Experience: Experience with Veeva Vault Quality Docs.

Additional Information:

• Candidate must be local to Upper Gwynedd, PA or Rahway, NJ.
• 3 days onsite work is required.

This position is crucial for ensuring that all procedural documentation within the GRACS organization is accurately maintained and compliant with required standards.

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