About Pfizer :
One of the major contributor of medicines globally ranking in top 10 pharma companies. The industry equipped with more than 1500 scientists with more than 5 million testing labs globally and over 36 clinical trials before the first perception. In the area of biotechnological medicine with 25000 clinical researchers testing every day world wide.
The company has located its head quarters in New York with the rank 57 in fortune 500 companies, founded in 1849, which is 170 years ago. Form have joint ventures with GSK and Mylan for improving the quality of medicines.
Large portfolio including branded and generics with products listed from A to Z. Applies rare diseases research to unveil the new therapy treatment, more than 30 million people in USA and 350 million globally uses the medicines for rare disease treatments. Several hematological and neurological rare disease therapies are in research phase. Gene therapy is one of the promising and rapidly developing portfolio in the companies profile, placing genetically corrected copies to patients cells. Having collaboration with Spark therapeutics and investigating SPK-9001. As a snapshot 35 projects are in Phase 1, 34 are being in phase 2, 23 in phase 3, 9 went for registration with a total of 101 (metrics as of July 2019)
Constantly providing medicines in the areas of Hospital (anti infectives), oncology, anti inflammatory, oncology, rare diseases, biosimilars, vaccines and new molecular entities.
About the Job
Job Location : Chennai
Job Role :
Oversees everyday administrative exercises related with appointed LEC varieties inside settled upon timetables.
Assess change controls for fulfillment, precision and required supporting archives. Start change controls when required.
Performs Market Effect Evaluation (MIA) for the particular substance name change.
Runs the Administrative Necessity Chief to decide the documenting activity and affected areas explicit for element name change and to get affirmation from the Territorial Administrative Lead.
Scan Administrative information bases for Normal Specialized Report parts or solicitation them from proper market contacts, when not accessible.
Knowledge of worldwide rules for recording Lawful Element Changes (LEC) and run comparing reports in the administrative necessities data set.
Ought to be know all about accommodation gathering rehearses.
Decipher and apply worldwide/territorial CMC administrative strategies.
Demand reports from the locales/markets/focus capabilities on a case by case basis.
Demand Auxiliary reports from Subordinate archives group.
Speak with business sectors if explanation/prioritization is required.
Circle back to all capable disciplines to have the option to meet courses of events.
Composing of the influenced CMC areas for example Module 3 under the direction from the CMC GRL as fitting and inside concurred timetables.
Liable for getting the endorsement in Reg-459 structure from GRL on the consummation of creating the segments.
Uses Pfizer's CMC frameworks, for example GDMS, PDM, SPA, and so forth, as fitting.
Should be incredibly coordinated as LEC ventures can stumble into different items/markets.
Guarantees consistence to Pfizer inner methodology and preparing SOPs