صاحب العمل نشط
حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيحالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيAbout Cetas Healthcare:
Job Responsibilities:
; QC of Regulatory documents (including but not limited to CSR, Narratives, CTD Modules, Investigator s Brochure, Protocol)
; Ensure that the Quality checked documents are in accordance with the company SOPs, guidelines, and agreed timelines and comply with established standards and performance metrics
Perform the project management activities for the project/ document assigned
Develop and maintain effective working relationships and facilitate communication among the project team members
; Identify issues and implement corrective and preventive ;
Impart training and mentor and groom the new incumbents, develop the therapeutic area, and document expertise
Preferred Experience:
Minimum 1 to 2 years experience in medical writing
Knowledge of Medical Device, basic understanding of European Medical Device Regulation (EUMDR).
Exposure to Post Market Clinical Follow up (PMCF) Studies for Regulatory
Experience in analysis, interpretation, and reporting the scientific data (analytical thinking).
Experience in working with EU regulatory agencies preferred
Exposure to multiple therapeutic areas
Excellent written and verbal communication
Job Location: Mumbai
دوام كامل