Collabera
Pharma Documentation Specialist - Hybrid
Collabera, Rahway, New Jersey, us, 07065
Description
HomeSearch JobsJob Description
Pharma Documentation Specialist - Hybrid
Contract: Rahway, New Jersey, US
Salary: $44.00 Per Hour
Job Code: 353900
End Date: 2024-10-17Days Left: 29 days, 3 hours left
Apply
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 andGlobal Pharmacovigilance Procedural DocumentationDevelop and manage integrated project plansConduct periodic assessments of procedural contentSupport and manage the overall documentation change control processMaintain and organize current effective documentation within logical groupings/categoriesSupport and manage requests for documentation for internal audits and inspectionsEducation Qualification:
Must have a Bachelor's degree or higher for this role.Required Skill:
6+ years of industry experienceFamiliarity with creating/revision of Regulatory Affairs and GlobalPharmacovigilance Procedural DocumentationAbility to develop and manage integrated project plansExperience in conducting periodic assessments of procedural content Knowledge of documentation change control processesProficiency in maintaining and organizing documentationExperience with Veeva Vault Quality Docs preferredCandidate must be local to Upper Gwynedd, PA or Rahway, NJ as 3 day onsite work is required.Job Requirement
Documentation SpecialistCAPAVeeva VaultDocumentationRegulatory AffairsPharmacovigilanceGlobal Pharmacovigilanceperiodic assessmentsMRLResearch LaboratoriesGlobal Regulatory AffairsClinical SafetyGRACSReach Out to a RecruiterRecruiterEmailPhoneRohan Lazarusrohan.lazarus@collabera.com
Apply Now
HomeSearch JobsJob Description
Pharma Documentation Specialist - Hybrid
Contract: Rahway, New Jersey, US
Salary: $44.00 Per Hour
Job Code: 353900
End Date: 2024-10-17Days Left: 29 days, 3 hours left
Apply
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 andGlobal Pharmacovigilance Procedural DocumentationDevelop and manage integrated project plansConduct periodic assessments of procedural contentSupport and manage the overall documentation change control processMaintain and organize current effective documentation within logical groupings/categoriesSupport and manage requests for documentation for internal audits and inspectionsEducation Qualification:
Must have a Bachelor's degree or higher for this role.Required Skill:
6+ years of industry experienceFamiliarity with creating/revision of Regulatory Affairs and GlobalPharmacovigilance Procedural DocumentationAbility to develop and manage integrated project plansExperience in conducting periodic assessments of procedural content Knowledge of documentation change control processesProficiency in maintaining and organizing documentationExperience with Veeva Vault Quality Docs preferredCandidate must be local to Upper Gwynedd, PA or Rahway, NJ as 3 day onsite work is required.Job Requirement
Documentation SpecialistCAPAVeeva VaultDocumentationRegulatory AffairsPharmacovigilanceGlobal Pharmacovigilanceperiodic assessmentsMRLResearch LaboratoriesGlobal Regulatory AffairsClinical SafetyGRACSReach Out to a RecruiterRecruiterEmailPhoneRohan Lazarusrohan.lazarus@collabera.com
Apply Now