Associate CSR job opportunity at Pfizer.

Home Jobs In Malaysia Tag: Job Associate CSR position at Pfizer


DateMore Than 30 Days Ago bot
Pfizer Associate CSR
Experience: General
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeAssociate
loacation Malaysia - Kuala Lumpur, Malaysia
loacation Malaysia - Kua..........Malaysia

This team ensures Pfizer's   Clinical Study Report   (CSR)   management   meets   global agency standards and manages regulatory reporting, dossier development, and submission activities for Global Regulatory & International Operations (RIO).   Members in the team   oversee   and   manage   end-to-end lifecycle   development   of CSR   to support Pfizer’s global drug registration and approval processes, including submission, publishing, and archiving of related reports and documents.   Associate   Lead the coordination,   compilation, quality control,   approval   and post-approval processes associated with development of Pfizer global CSRs    Create CSR   mockups   in System and populate document templates   Project manage CSR compilation,   approval   and publishing activities   Execute submission ready   Quality Control ( QC )   on CSR components and structure   Communicate with function lines   regarding   issues with CSR components and seek resolutions   Seek approval from signatories on   finalized   CSRs and update clinical trial registry with CSR milestone status   Prepare investigators declaration packages for distribution to the coordinating investigator   Prepare study data packages required for distribution to study   Principal Investigator s   ( PIs )   Coordinate   Public Disclosure Synopsis   ( PDS )   and   Plain Language Summary   ( PLS )   activities   Publishes the approved report into Pfizer standard   submission-ready   and   regulatory   compliant package ,   and   contributes to su bmission   package     Files t he   report to   Trial Master Files   (TMF)   system   to meet   regulatory requirements   Monitor public mailbox      Provide ongoing quality reviews and process improvement suggestions to the work group or project team, supporting continuous enhancement of CSR coordination practices      Work Location Assignment: Hybrid Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Regulatory Affairs

Other Ai Matches

血友病-（高级）客户解决方案地区经理 Applicants are expected to have a solid experience in handling Job related tasks
医学信息沟通专员 Applicants are expected to have a solid experience in handling Job related tasks
【医学部】(Sr.) MSL-Gastrointestinal(GI)-北京或广州 Applicants are expected to have a solid experience in handling Job related tasks
Director, Enterprise Architect - PGS Applicants are expected to have a solid experience in handling Enterprise Architect - PGS related tasks
Recruiting Onboarding Delivery Associate Applicants are expected to have a solid experience in handling Job related tasks
Pharmaceutical Attendant, M19, A2 Applicants are expected to have a solid experience in handling M19, A2 related tasks
（高级) 客户互动经理 （Sr.) Customer Engagement Manager Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Cardiovascular Health and Science Professional (HSP) - Highland Park, IL Applicants are expected to have a solid experience in handling IL related tasks
代谢事业部-医学信息沟通专员-惠州 Applicants are expected to have a solid experience in handling Job related tasks
[ONC] Hematology Oncology Commerical Lead Applicants are expected to have a solid experience in handling Job related tasks
Healthcare Executive Applicants are expected to have a solid experience in handling Job related tasks
Executive Operations Assistant Applicants are expected to have a solid experience in handling Job related tasks
Medical Review Manager Applicants are expected to have a solid experience in handling Job related tasks
Clinical Development Medical Senior Director Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Health Solution Partner Applicants are expected to have a solid experience in handling Job related tasks
Neuroscience Health and Science Professional - Columbus, IN Applicants are expected to have a solid experience in handling IN related tasks
MIC DM-Metabolism BU-Guangzhou Applicants are expected to have a solid experience in handling Job related tasks
RA/Gastroenterology, Medical Affairs Scientist, Medical Manager/Associate (Field Medical) Applicants are expected to have a solid experience in handling Medical Affairs Scientist, Medical Manager/Associate (Field Medical) related tasks
Apotheker als Prozessmanager (m/w/d) in der Produkt- und Prozessentwicklung Applicants are expected to have a solid experience in handling Job related tasks
医学信息沟通专员 Applicants are expected to have a solid experience in handling Job related tasks
Data Operations Specialist (Contractor) Applicants are expected to have a solid experience in handling Job related tasks
辉瑞制药-Medical Science Liaison-代谢-广州 Applicants are expected to have a solid experience in handling Job related tasks
Senior Manager CSSV AI Compliance Lead Applicants are expected to have a solid experience in handling Job related tasks