Key Responsibilities:
Coordinate centralized support for uploading CPP documents (e.g., population PK/PD data transfer plans, analysis plans, and reports) into regulatory systems in compliance with global procedures.
Prepare and review CPP documents for submission, ensuring accuracy, consistency, and inspection readiness.
Provide scientific writing support for memos, reports, and health authority responses.
Implement and refine QC processes for CPP documentation, including maintaining QC checklists and tracking comment resolution.
Collaborate with CPP leaders and cross-functional teams to ensure timely delivery of high-quality documents.
Support development of templates for CPP reporting, analysis plans, and data transfer plans.
Maintain central planning and tracking of CPP document deliverables and timelines.
Education & Experience Requirements
Bachelor’s degree in health sciences, life sciences, or related field.
Industry experience in scientific writing and document QC.
Proficiency in Word templates and document formatting.
Strong organizational and project management skills.
Excellent written and verbal communication skills in English.
Familiarity with population PK/PD report writing and review preferred.
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