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Pharma Documentation Specialist

2 months ago

Rahway, United States Collabera Full time

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.