**Job Description:**
As a Documentation Specialist, you will play a crucial role in the coordination of centralized support by the document service management group for the upload of relevant Clinical Pharmacology & Pharmacometrics documents within the required regulatory system.
You will be responsible for delivering high-quality coordination, performing memo and report strawman support, document quality control (QC), preparing Clinical Pharmacology & Pharmacometrics documents for submission or health authority interactions, providing writing support, implementing QC process refinement as defined by the Clinical Pharmacology & Pharmacometrics organization, and tracking the operational progress amongst stakeholders.
**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.
**Requirements/Qualifications:**
We are seeking an individual with:
* A minimum degree in a health, science, or computer science related field.
* Strong experience working in the Pharmaceutical or CRO Industry.
* Proficient with word templates and document formatting.
* Experienced in scientific report writing and document QC procedures.
* Project Management and organizational skills, ability to prioritize multiple projects.
* Proficient in speaking and writing in English. Effective communication skills, oral and written.