DDReg Pharma Hiring Senior Medical Writer

DDReg Pharma Hiring Senior Medical Writer

12 August, 2022

DDReg Pharma Hiring 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

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