Primary Talent Partners
Documentation Specialist III
Primary Talent Partners, Rahway, New Jersey, us, 07065
Primary Talent Partners has a 14 month contract opening for a Documentation Specialist to join a multinational pharmaceutical company for a hybrid position in Rahway, NJ.
Pay:
$40.00/hr - $45.00/hrContract:
W-2, 14 months, extensions likely, conversion possibleOnsite/Hybrid:
Candidate must sit onsite 3 days a week in Rahway, NJ.
Responsibilities:
Supports the operational aspects of procedural documentation management and advises on documentation strategy fo Global Regulatory Affairs & Clinical Safety (GRACS) organization within company Research Laboratories (MRL).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.Qualifications:
Must have a Bachelor's degree or higher for this role.6+ years of industry experience and familiarity with the skills below.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 developmentFacilitates documents through draft, review and approval cycles to meet required timeframes for release and implementationconduct 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 approvalMaintain and organize current effective documentation within logical groupings/categories to facilitate ease of access for GRACS end usersSupport and manage requests for documentation for GRACS internal audits and inspections for process documentationVeeva Vault Quality Docs experience preferred.Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
#LI-PTP
Pay:
$40.00/hr - $45.00/hrContract:
W-2, 14 months, extensions likely, conversion possibleOnsite/Hybrid:
Candidate must sit onsite 3 days a week in Rahway, NJ.
Responsibilities:
Supports the operational aspects of procedural documentation management and advises on documentation strategy fo Global Regulatory Affairs & Clinical Safety (GRACS) organization within company Research Laboratories (MRL).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.Qualifications:
Must have a Bachelor's degree or higher for this role.6+ years of industry experience and familiarity with the skills below.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 developmentFacilitates documents through draft, review and approval cycles to meet required timeframes for release and implementationconduct 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 approvalMaintain and organize current effective documentation within logical groupings/categories to facilitate ease of access for GRACS end usersSupport and manage requests for documentation for GRACS internal audits and inspections for process documentationVeeva Vault Quality Docs experience preferred.Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
#LI-PTP