DDReg Pharma Hiring Senior Medical Writer
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 firstname.lastname@example.org