Associate Safety Project Manager
Net2Source Inc. - Rahway, NJ
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Job Title: Documentation Specialist - III (Senior)Location: Upper Gwynedd, PAor Rahway NJ (3 days onsite)Duration: 2 Months Contract(Extendable)Pay Range: $40 - $44.84 per hour on W2.Supports the operational aspects of procedural documentation management and advises on documentation strategy for 's Global Regulatory Affairs & Clinical Safety (GRACS) organization within 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.Quals--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. Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Created: 2024-10-04