Consultant will work with PDQ GCP/GVP team to complete procedural document support activities. The consultant will update seven document packages within PDQ specified timelines in collaboration with Global Process Owners and Subject Matter Experts and to PDQ quality standards. Document packages includes all related documents (SOP, Work Instructions, Forms and Supporting instructions) specific to detail an end-to-end process. Document Packages to be delivered include: 1. Core Data Sheet & Product Information
2. Regulatory Commitments
3. Serious GCP Noncompliance
6. Safety Regulatory Documentation
7. Signal Management
1. Revise existing clinical procedures to meet regulatory agency compliance standards and internal operational requirements.
2. Apply technical knowledge and clinical quality expertise when developing the documents.
3. Partner with client on content and to finalize documents. Ensure all procedures are:
• Executable as written
• Adhere to regulatory agency requirements and cGCP standards
• Alignment with industry convention and expectations
• Are defendable in an inspection or third party audit
• Align with and properly reference related internal processes and systems
4. Perform technical writing on all procedures:
• Language and grammar
• Formatting and copy-editing
• Cross references are accurate and complete
• Free of typos and errors
• Correction of ambiguous or confusing wording
• Ensure integrity of content; to not change meaning 5. Do the “heavy-lifting”; minimize client resources wherever possible.
6. Follow-up with reviewers and stakeholders to ensure documents meet project timelines.
7. Partner with client team members to identify issues, formulate recommendations, and execute solutions, as applicable.
8. Document gaps, risks, and likelihood of occurrence; facilitate risk mitigation activities. Ensure accepted risks and risks with long-term remediation horizons are clearly documented, justified, and decision makers noted.
9. Lead and facilitate document review meetings. Focus on reconciling feedback and adjourning with approvable documents.
10. Manage document approval process.
11. Develop, manage, and routinely publish a project status report that:
• Contains a complete list of all items in scope
• Lists due dates for each step of the development and approval process
• Aligns with the client project milestones
• Captures document status; includes those that are late, with whom, and why 12. Provide a list of parking lot and open items (if any) at time of handoff.
13. Accommodate teleconferences with individuals in other geographies as required.
1. Knowledge of GCP and GVP Regulations.
2. Experience working with Pharmaceutical Industry Clients.
3. Experience working with stakeholders to implement processes (including senior level management as well as individual contributors).
4. Experience identifying areas of conflict and creating resolution plans.
5. Experience in documenting processes and following writing conventions to produce quality documents.
6. Experience with electronic data management systems (Documentum) and SmartSheets.