Clinical Pharmacology & Pharmacometrics Scientific Writing & Reporting Principal Scientist

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Pharmacokinetics & Pharmacometrics

Job Category:
Scientific/Technology

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

The Clinical Pharmacology & Pharmacometrics (CPP) Scientific Writing & Reporting Principal Scientist is responsible for writing documents, coordinating reviews, performing document quality control (QC) and managing (e.g.

timelines, resources, and metrics) CPP deliverables including but not limited to shell drafts of pharmacometric analysis and data transfer plans, pharmacometric memos and reports, and other types of CPP deliverables.

 This role will also collaborate with cross functional teams to streamline the coordination of consistent document upload within the required regulatory document management system.

Driving effective contributions to process enhancements including automation are key to this role.

 This function liaises closely with stakeholders to ensure timely & high quality delivery of documents, in line with applicable guidelines and regulations.

Main Accountabilities



* Write and coordinate, shell draft, review, and/or final versions of CPP owned documents, including but not limited to, analysis and data transfer plans based on study protocols, and various types of reports related to pharmacometrics and other types of analyses.


* Facilitate timely reviews and approval of written documents.


* Perform document QC of CPP deliverables and manage the review process, including timely documentation within the applicable document QC checklist, comment resolution follow up, lead document QC meeting in close collaboration with other colleagues within CPP, as required.


* Oversee the central planning of document writing & QC of CPP deliverables, track project progress and support of metric reporting.


* Actively contribute to process improvements in support of interactions between Clinical Pharmacology & Pharmacometrics and cross-department stakeholders.


* Support the development and maintenance of CPP reporting templates, analysis plans, summary documents, data transfer plans, as required in close partnership with the document service management group.


* Lead/contribute to process improvement and automation initiatives.

 Revise, update and create (if needed) SOPs, Job aids, templates, training materials for CPP internal processes and other cross departm...