Description:
Remote – EST business working hours required (8:00 AM – 5:00 PM EST)
Support a high-impact documentation project for a large biotech pharmaceutical leader as part of a global SAP S/4HANA transition. In this role, you will assist in the creation, revision, and management of GxP and non-GxP documentation, working closely with business process leads and project stakeholders. This position offers a unique opportunity for professionals with regulated documentation experience, especially those familiar with Veeva and OTC (Order to Cash) processes.
Responsibilities:
Documentation Creation and Revision
Work with Business Process Leads to create and revise GxP documentation, including SOPs, Work Instructions, Business Process Documents, and Forms to align with new SAP S/4HANA processes.
Develop and update non-GxP documentation as needed to support process transitions.
Change Management and Workflow
Assist in creating and managing change requests for training and documentation within systems like Veeva and LMS.
Support management of documentation workflows within the Quality Management System (Veeva), ensuring compliance with validation timelines and project deadlines.
Status Reporting & Data Management
Help assemble regular status updates for Order to Cash (OTC) E2E leads and workstreams regarding documentation progress.
Utilize Smartsheet dashboards to track document progress, link parent/child documents, update statuses, and ensure data accuracy.
Quality Assurance and Compliance
Ensure all documentation adheres to GxP regulations and internal company standards.
Verify the accuracy, completeness, and clarity of information in revised documents.
Participate in document review and editing to ensure content is clear, concise, and effective.
Requirements:
Experience managing documents in Veeva (non-negotiable)
Experience managing Order to Cash (OTC) processes
Experience managing GxP document revision
Project management experience in a regulated or process-driven environment
Technical writing skills and the ability to deliver high-quality documentation
Excellent organizational, collaboration, and communication skills
Experience working both independently and as part of a team, ideally in virtual/remote and global settings
Familiarity with electronic clinical trial/SOP/document systems (e.g., Veeva)
Good working knowledge of Microsoft Word and Smartsheet
Experience in R&D or pharmaceutical industry, with knowledge of quality and compliance
Pay Rate between $38 - $43/hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
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