Senior Manager, Submission Planning for Global Registration (SMSPGR-MS)

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

Establish and lead development of cross-functional regulatory submission process map that serves as a standardized approach to be used by all Clinical Development Project Teams preparing for regulatory filings. Lead broader communication of the submission process map to all relevant functions. Own and maintain changes to the process map through periodic updates. Support Development Project Management in the coordination, tracking, and on-time delivery of all cross functional activities that contribute to the compilation of a regulatory submission package for registration. In collaboration with cross functional team members, establish a standard submission template along with defined metrics and resource requirements for all submission work streams and deliverables. Along with the Development Project Manager, create and maintain detailed submission plans for all key markets by collaborating with representatives from other functional areas whose contributions are required for regulatory submissions. Support Development Project Management leads in the input, maintenance, and revision of the submission plan for assigned projects. Ensure consistency across all submission plans. Identify submission related risks and propose mitigations. Take on additional responsibilities related to launch planning and readiness across all regions as need arises. Foster effective and productive communication among various cross-functional team members via proactive networking. Provide regular status updates to key stakeholders.

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Job Posting: 853251

Posted On: Oct 05, 2021

Updated On: Nov 05, 2021