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Submission Manager
4 maanden geleden
Responsible for contributing to the planning, coordination, development and timely delivery of high quality Clinical submission documents to Regulatory Affairs (RA) for 1) New Drug Applications (NDA), Biologic Licensing Applications (BLA), Marketing Authorization Applications (MAA) and supplemental NDAs/BLAs/ Type II variations, 2) for related follow-up activities (e.g.
Safety Updates, answers top Health Authority (HA) questions).YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
- Provide cross-divisional Clinical submission contributions and serve as content/technical contributor for Clinical submission document requirements for assigned programs supported by Submission Management Department.
- Contribute to the global cross-functional Clinical Submission Team to ensure all Clinical submission documents are delivered in accordance with timelines, high quality, operational and technical procedures; report Clinical submission progress and issues with a resolution plan to Group Heads of Submission Management, Regulatory Affairs and other relevant line units Heads,as needed.
- Contribute to the Clinical Submission Planning Meeting with cross functional team members to define Clinical submission content, data pooling strategies for summary documents (e.g. Summary of Clinical Efficacy (SCE) and Summary of Clinical Safety (SCS)) and identify full Clinical Submission Team composition; provide meeting agenda and meeting minutes.
- Facilitate definition of delivery schedule and batch content for statistical outputs and medical writing strategy ensuring continuous receipt, review and integration into Summary Documents (e.g. SCE, SCS and Clinical Overview (CO)).
- Contribute to the identification of all Clinical submission deliverables (including all relevant trials); negotiating and tracking timelines, accountabilities and responsible individuals assigned, in collaboration with Clinical Submission Team members for HA filings; include on RA submission tracker and maintain with real-time updates.
- Identify issues and potential resource gaps effecting preparation and delivery of Clinical submission documents across line functions; negotiate and implement solutions.
- Contribute to pre-submission Health Authority briefing books.
- Co- facilitate extended Clinical Submission Team meetings to synchronize submission messages with Senior Management at:a. Clinical Submission Team Kick-off – goal is to ensure clear submission strategy and early target labeling messages endorsed by Senior Management and understood by all Preclinical and/or Clinical submission team members; all contributing line units present proactive assessment of key issues and actions within their lines which will effect timely delivery of Preclinical and/or Clinical submission documents. Agenda and meeting minutes issued by Submission Manager (SM).b. Key Message Harmonization Meeting – goal is to ensure Senior Management and cross functional development departments are aligned on key efficacy, safety, Biopharmaceutics and Clinical Pharmacology messages following receipt of key pooled Clinical data. Agenda and meeting minutes issued by SM. Meeting cofacilitated with RA.
- Lead or contribute to regularly scheduled Clinical Submission Team meetings, provide agenda, minutes and updates to deliverable timelines; ensure timelines are in accordance with Novartis processes
- Represent Clinical Submission sub-team at RA Core Submission Team Meetings and RA submission team operations' meetings (providing status updates/presenting issues and mitigation plans), as applicable
- In collaboration with the Clinical authors (e.g. Global Program Medical Director, Program Statistician, Brand Safety Leader, etc.) co-facilitate SCE and SCS Data Analysis Review Meetings to align analysis interpretation of these Clinical summary documents for inclusion into the SCE and SCS draft reports as applicable
- Co-facilitate Summary Document Report Review Meetings to aid in the development of these documents from draft to content final in collaboration with Medical Writers and Clinical Authors via direct team interaction and dialog (e.g. teleconference, videoconference, or face to face); facilitate obtaining final approval from Clinical, Analytics, Safety and RA Therapeutic Area Heads.
- Contribute to the authorship of the following (but not limited to), supportive Clinical submission documents (as appropriate to the submission); ensuring content and technical compliance with International Conference on Harmonization (ICH) and local Health Authority guidelines:a. CTD Financial Disclosure Certificationb. CTD Information about the experts - clinicalc. CTD 1.9. Information relating to clinical trialsd. CTD List of referencese. CTD Synopsis of Individual Studiesf. CTD 5.2 Tabular Listing of All Clinical Studiesg. CTD Statement on CRFs and individual listings
- Co-facilitate discussion and proactive preparation with relevant Clinical submission team members for summary Clinical site information supporting FDA Office of Scientific Investigations (OSI) Inspections for each FDA submission or information supporting EMA accelerated assessment
- Contribute to the validation checks of RA cross reference links established for all managed Clinical Submission deliverables within the Common Technical Document (CTD) prior to Health Authority dispatch.
