This role will provide strategic and operational support, which includes coordinating and compiling quality control feedback to the clinical authors on Key Clinical Submission Documents included as part of New Drug Applications (NDA) and Marketing Authorization Application (MAA) global submissions. |
Primary contact for coordinating QC timing between Oncology Submission Management (OSM), Global Clinical Submissions and Clinical Project Teams to ensure QC review of key submission documents, including Clinical Study Reports and Investigator Brochures Liaise with OGD Drug Regulatory Affairs (DRA), DRA Operations, and OSM representatives for proper representation at global tracking meetings and internal observance of the agreed upon timelines
Coordinate quality control review with quality control reviewers to complete QC review by agreed timelines
Compile QC findings from multiple QC reviewers for each clinical summary document.
Review QC findings with Clinical Author, Program Statistician and document Medical Writer for approval and acceptability of findings. Liase with Submission Writer / Clinical Submission Manager to ensure accepted QC findings are integrated into the clinical summary document before it is released to DRA Operations. Monitor identified issues for trending purposes, conduct training / implement solutions for clinical authors as appropriate.
.Ensure final QC Findings Form is signed by Clinical Author, Program Statistician and Medical writer and archived in CREDI Communicate status reports to Submission Leader / Line Function Management Maintain advanced knowledge of current electronic submission standards, regulatory guidelines and legal requirements.
Train project teams and / or line functions on ‘submission readiness’ requirements for submission components.
Advanced degree or equivalent education/degree in life science/healthcare is required Fluent English (oral and written) ≥ 10 years experience in clinical research with proven proficiency in global clinical development. Ability to understand, interpret complex medical/scientific data and effectively communicate inaccuracies in clinical summary documents to authors. Demonstrates strong medical/scientific communications (written) Proven ability to work independently to deliver clinical summary document discrepant findings within defined timelines (e.g. 4-5 working days). Solid computer technical skills (Word/Excel/PDF development) and ability to learn new systems quickly. Previous experience in clinical development of NDA/MAA deliverables preferred. Previous experience in project management / quality assurance preferred. Advanced knowledge of CREDI and PREDI preferred Previous clinical experience working on NDA and MAAs preferred
Novartis - 2 years ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...