DDReg Pharma Pvt Ltd hiring Senior Medical Writer for Vikhroli West, Mumbai location
Position – Senior Medical Writer
Job description :
Drafting of following common technical documents for generic filings:
Modules 2 (Clinical Overview, Nonclinical Overview, Clinical and Nonclinical summary)
Module 4 (Nonclinical Study Report)
Module 5 (Clinical Study Report/CSR-Oncology)
Drafting core summary of product characteristics (SmPCs) and clinical expert statement for European filings
Drafting of SmPCs and Patient Information Leaflets (PILs)
Drafting of Clinical Expert Statements (CESs)
Drafting of safety narratives
Updating Investigator Brochure (IB).
Drafting other regulatory documents for European filings
Maintain records for all assigned projects including archiving
Maintain the checklist for the documents prepared
Carry out detailed searches in regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA etc for safety alerts
Possess knowledge of Clinical Research, Drug Safety, Pharmacovigilance, Case Report Form (CRF), PSUR, DSUR, Information Brochure, Clinical Trials Protocols, Regulatory authorities, BA/BE, PK-PDS.
Mentor Associates on job skills, oversees or develops training plans or materials for safety associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel.
3-5 yrs of RMP experiences shall be preferred
Job Location : Vikhroli West, Mumbai. (WFO)
Interested Candidates share resume at hetal.y@ddreg.in
