Talent Software Services
Documentation Specialist - III
Talent Software Services, Rahway, New Jersey, us, 07065
Supports the operational aspects of procedural documentation management and advises on documentation strategy for the client's Global Regulatory Affairs & Clinical Safety within the client's Research Laboratories (MRL). The role is responsible for supporting Global Regulatory Affairs & Clinical Safety 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 Global Regulatory Affairs & Clinical Safety business activities.
Qualifications: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 Global Regulatory Affairs & Clinical Safety end users • Support and manage requests for documentation for Global Regulatory Affairs & Clinical Safety internal audits and inspections for process documentation • Veeva Vault Quality Docs experience preferred.
Qualifications: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 Global Regulatory Affairs & Clinical Safety end users • Support and manage requests for documentation for Global Regulatory Affairs & Clinical Safety internal audits and inspections for process documentation • Veeva Vault Quality Docs experience preferred.