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Key Responsibilities

• Ensure all PK/PD deliverables are inspection-ready and compliant with relevant requirements and internal guidelines.
• Maintain central planning for population PK/PD document writing and QC deliverables.
• Provide recommendations for process improvements to enhance interactions between CPP and document service management teams.
• Drive PK/PD document shell creation, QC processes, and timeline management.
• Receive and review documents (e.g., reports), compile comments and edits, and follow up on comment resolution in close collaboration with stakeholders.
• Perform QC of PK/PD reports, manage review cycles, and document findings within QC checklists, ensuring timely resolution of comments.
• Support development of CPP reporting templates, analysis plans, and data transfer plans in partnership with document service management.
• Draft and review protocols, PK/PD statistical analysis plans, TLFs/TLF shells, and clinical study reports.
• Conduct Non-Compartmental Analysis (NCA) using Phoenix WinNonlin 8.3.
• Draft and review programming specifications for PK/PD studies.

Skills & Experience

• Proficient in using Word templates and document formatting.
• Strong experience in scientific report writing and document QC procedures.
• Solid project management and organizational skills; ability to prioritize multiple projects effectively.
• Excellent communication skills (oral and written) in English.
• Experience in population PK/PD report writing and review.
• Familiarity with PK/PD analysis tools and processes, including Phoenix WinNonlin.