Job Description

Functions as an Global Tenders supporter for Brands-Global Tenders team, to support all the human health products (small molecule and Bios, except Consumer products) in all markets including tender bids from government agencies, hospitals, philanthropic organizations, etc. Responsible for managing, requesting, end to end tracking of CMC ancilliary documents in ARS system requested by GRSCMCs for CMC submissions. Tenders Support Responsibilities: Monitors GCTS tender mailbox and Outlook for requests. Searches Regulatory databases and collects and compiles CMC information requested for a tender before sending for review to the CMC GRL. Requests data from the sites as needed for a tender. Requests Ancillary documents from Ancillary Documents Team. Communicates with markets if clarification/prioritization is needed or extension of time line is needed. Follows up with all responsible disciplines to be able to meet timelines. Works with CMC GRLs in finalizing the request and compiles final tender bid package for dispatch to the requestor. Maintains a record of information provided Manages requests via the Submission Planning Application (Trackwise system). Supports use of regulatory systems and managing documentation and information, including setting up standard formats or reports for recurring requests and status updates as needed. Triages and project manages multi-product data collection projects Anciliary Team Responsibilities: Responsible for end to end tracking of CMC ancilliary documents requested by GRSCMCs for CMC submissions.The primary responsibilities of the Ancilliary Co-ordinator are, Routinely checks for new/updated ancillary document requests. Obtains clarification from the requestor, as needed. Determines if required ancillary document is available and current. Requests ancillary documents from appropriate sources, providing due dates another appropriate information. Collaborates with site CNMs/COQAs. Notifies Team Lead and Requestor if due date concerns arise. Regularly follows up with the appropriate stakeholders to provide the document within the due date. Notifies the stakeholders of any update or rework in the existing ancillary request. Confirms appropriateness of the documents received. Coordinates with stakeholders to correct and errors found. Loads documents into GDMS, links documents/vDocs, as appropriate. Updates ancillary document requests in appropriate system, as needed. Work Location Assignment:Flexible Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs#LI-PFE

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