Documentation Specialist - III

Pay rate: $40-$45/HR on W2
Location: You can work from Rahway NJ or West Point PA
Education: Must have a Bachelor's degree or higher for this role

Required Experience: 6+yrs industry experience and familiarity with the following:
• Support and manage the creation/revision of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation (e.g., Standard Operating Procedures, Job Aids, Forms, Process Guides, and User Manuals)
• Develop and manage integrated project plan - Lead &/or complete documentation impact assessments to identify impact of process changes across the library of documents - Support process owners in the development of process maps in support of procedural documentation development
- Facilitates documents through draft, review and approval cycles to meet required timeframes for release and implementation
• conduct periodic assessment of procedural content to ensure adherence to format, content, and style guidelines, and identify improvement opportunities to 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 for GRACS internal audits and inspections for process documentation
• Veeva Vault Quality Docs experience preferred

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


Responsibilities:
The role is responsible for supporting GRACS Document Owners and Functional Areas in the development, revision, implementation and maintenance of their procedural documentation (policies, standard operating procedures and supporting documents) related to global Regulatory Affairs and/or Pharmacovigilance activities
The role collaborates with Business Process Leads, Functional Leads, Document Owners, and Subject Matter Experts (SMEs) to ensure the documentation conforms to MRL standards for classification within a prescribed documentation hierarchy, and adequately reflects the intended processes to support GRACS business activities


If interested ; kindly share your resume with answers:
Q1: How many years of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation exp (e.g., Standard Operating Procedures, Job Aids, Forms, Process Guides, and User Manuals)
Q2: How many years of exp in Leading &/or complete documentation impact assessments to identify impact of process changes across the library of documents
Q3: How many years of exp in development, revision, implementation and maintenance of their procedural documentation (policies, standard operating procedures and supporting documents) related to global Regulatory Affairs and/or Pharmacovigilance activities
Q4: How many years of exp in Veeva Vault Quality Docs
Q5: This is hybrid role based in Rahway or West Point PA ; which location you want to work from ?