Author and Maintain Regulatory Product profile documents by updating as requested by strategist when key milestones occur. Including status of product indications supplement status per AG settlement
Generate Pearl reports, WWRS reports etc, in support of Renewals, launches and health authority queries on need basis.
Author and QC electronic applications, cover letters, submission packages including IND & Protocol amendments as requested by Strategist in support of new registrations & life cycle maintenance of products.
Support registration of new products by Dossier QC, CCS QC, gap analysis, anticipated health authority query tracker and coordination between stake holders.
Support QC of Pre-IND meeting minutes, EMA Scientific Advice dcuments, Type C briefing package
Quality check of submission packages like NDA AR, PADER, PSUR, DSUR, CAR and PBRER.
Author and maintain Global Regulatory Strategy Documents as requested by strategist
Author and maintain Label As a Driver (LAD) documents as requested by strategist
Prepare Clinical trail intelligence & competitive documnts for the assigned program (ex GLP 1 agonist)
Lead Clinical study meetings
Support data analysis, data mining, report generation using various Pfizer internal systems like GDMS, Pearl, Label Central, CAL-ODW, Epalms etc.
Support GDMS archrivals, ROC creation using SCC support, GDMS folder creation etc., in support of archiving agency correspondences in GDMS.
Create, maintain and update internal trackers for cluster, product submissions/ variation trackers etc as requested by strategist and cluster group
Upload on-going clinical study documents into Pfizer Trial Master file as requested by strategist.
Provides guidance and support to junior staff in the systems & processes
Provides peer review support to the documents/submissions as assigned by the Group Lead
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.