Pharma Documentation Specialist - Hybrid
Collabera - rahway, NJ
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About the Role: The role involves supporting the operational aspects of procedural documentation management and advising on documentation strategy for Global Regulatory Affairs & Clinical Safety (GRACS) organization within Research Laboratories (MRL). The position is responsible for assisting GRACS Document Owners and Functional Areas in developing, revising, implementing, and maintaining procedural documentation related to global Regulatory Affairs and/or Pharmacovigilance activities. Responsibilities: Support and manage the creation/revision of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation Develop and manage integrated project plans Conduct periodic assessments of procedural content Support and manage the overall documentation change control process Maintain and organize current effective documentation within logical groupings/categories Support and manage requests for documentation for internal audits and inspections Education Qualification: Must have a Bachelor's degree or higher for this role. Required Skill: 6 years of industry experience Familiarity with creating/revision of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation Ability to develop and manage integrated project plans Experience in conducting periodic assessments of procedural content Knowledge of documentation change control processes Proficiency in maintaining and organizing documentation Experience with Veeva Vault Quality Docs preferred Candidate must be local to Upper Gwynedd, PA or Rahway, NJ as 3 day onsite work is required.
Created: 2024-09-20