Skip to content

Job Openings

Remote GCS Document Specialist

New Haven, CT 06510

Posted: 06/05/2024 Employment Type: Contract Job Category: Procurement/Supply Chain Job Number: 606019 Is job remote?: Yes Country: United States

Job Description

GCS Document Specialist
Day-to-day Operations
  1. Collaborate with CSMs on maintenance of GCS operations-related documents for all active and upcoming studies (list below)
    • Examples: checking for most current document versions, ensuring approval completeness, maintaining list of key study contacts, etc
  2. Ensure accuracy and completeness of GCS study documents in team storage space (BOX and Sharepoint) by performing regular filing, review, and organization of controlled documents
  3. Assist CSMs in managing document review and approval in DocuSign/ Adobe e-Sign
  4. Interface with internal functions and external vendors (Almac, Catalent, PCI, Endpoint, etc) to obtain and maintain GCS study documents generated in day-to-day GCS operations
  5. Streamline process for document storage and archiving across GCS studies by identifying and driving areas of improvement


Inspection Readiness Support
  1. Support CSMs during audit and inspection activities by compiling and requesting study documents in anticipation of auditor/inspectors’ requests
    1. Typically documents not already in BOX study folders
  2. Collaborate with TMF specialist to ensure all TMF filings are accurate and contemporized for all GCS studies, particularly ahead of study audits and inspections
  3. Assist CSMs with Storyboard creation and maintenance via communicating with involved functions and reviewing related study documents and/or TrackWise reports

Potential Areas of Support
  1. Act as the GCS POC for document storage transition from one BOX to Sponsor BOX and OneDrive
  2. Create and maintain GCS documents in Vault, the GMP environment
  3. Assist with PO requests in terms of Smartsheet submission and quote approval in Coupa

Key GCS study documents: Packaging/Labeling/Distribution:
Request for Packaging (Blinded and Unblinded RFP), Variable Data Request, Label Links and Rand, Packaging Specifications (PS), Certificate of Compliance/Conformance (CoC), Certificate of Analysis (CoA), Certificate of Testing (CoT), Partial Manufacturing Certificate, QP certificates, IMP release Certificates, Global Distribution Specifications (GDS), Drug Return Instructions (DRI), Certificate of Destruction (CoD)
IRT:
IRT specifications (Endpoint PULSE and Almac IXRS), Endpoint DRIVE Specifications, User Acceptance Test (UAT) Log, IRT User guides, DRIVE User Manual, Drug Return Instructions (DRI), Data Change Requests (DCR), IRT Report for Returns Discrepancy, IRT Validation Certificate
    • Audit trail report requests for site/user changes for audits and inspections Study Maintenance:

Study Protocol, Pharmacy Manual (PM), Vendor Oversight Plan (VOP- GCS and study-level), Meeting Minutes, Purchase Order (PO) requests, Clinical Supply Agreement (CSA)
Quality (with GCSQ and external QA):
Vendor Deviation Reports
CSR:
Appendix 16.1.6 (study lot information)
Vault (Tentative):
Clinical Label Approval Document (CLAD), Finished Product (FP) Specifications, Standard Operating Procedure (SOP) updates and lifecycle management

Italicized items are tentative
Disclaimer: This list is not comprehensive and is subject to change

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About New Haven, CT

Ready to launch your career in the vibrant area around New Haven, Connecticut? Explore a plethora of exciting job opportunities in this bustling hub of innovation and culture. Boasting renowned landmarks like Yale University, the historic Shubert Theatre, and the stunning New Haven Green, this region offers a perfect blend of urban charm and natural beauty. With a thriving arts scene, delectable cuisines like the classic New Haven-style pizza, and an array of outdoor recreation options at East Rock Park and Long Wharf, this area is a haven for career growth and work-life balance. Join us in discovering the endless possibilities that await your professional journey in this enchanting corner of the Constitution State.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.