PK / PD Documentation Specialist (m / w / d)

Deliver high quality coordination of the centralized support by the document service management group for upload of relevant Clinical Pharmacology & Pharmacometrics (CPP) documents (e.g. population PK / PD data transfer plans, population PK / PD analysis plans and population PK / PD reports) within the required regulatory system per global aligned procedures of client. Perform memo and report strawman support, document quality control (QC), prepare Clinical Pharmacology & Pharmacometrics documents for submission or health authority interactions, provide writing support, implement QC process refinement as defined by the Clinical Pharmacology & Pharmacometrics organization, and track the operational progress amongst stakeholders. Services are delivered by applying organizational and scientific writing skills to support document writing and QC in line with applicable guidelines and regulations.

Responsibilities

• Clear communication with clinical pharmacology & pharmacometric leaders and other team members.
• Ensure deliverables are inspection ready and compliant with relevant requirements.
• Maintain the central planning of population PK / PD document writing and QC deliverables.
• Provide advice / recommendation on process improvements in support of interactions between Clinical Pharmacology & Pharmacometrics and the document service management group.
• Drive the PK / PD document shell writing, document QC process, management of deliverable timelines; receive, and review documents (e.g. reports), compile comments and edits; follow up on comment resolution in close collaboration with the team.
• Provide PK / PD document QC of reports and manage the review process, documentation within QC checklist, including comment resolution follow up, within projected timelines, in line with the analysis plan and internal guidelines.
• Support the development of CPP reporting templates, analysis plans, data transfer plans, as required in close partnership with the document service management group.

Education and Experience Requirements / Qualifications :

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