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:

1. 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.

2. 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.

3. 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.

4. 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"