Manager/ Sr. Manager -Medical Monitoring | Cipla | Mumbai

Job Description

Manager/ Sr. Manager -Medical Monitoring – Clinical Strategy

Roles and Responsibilities

  • Develop a clinical strategy for the assigned product for the given market in order to meet the filing timelines
  • Ensure the robustness of the clinical strategy by interacting with internal cross-functional teams and external stakeholders
  • Oversee the execution of a clinical development plan by periodic review of data and impact analysis to ensure the clinical strategy objectives are met.
  • Provide scientific support to finalize the study protocols and regulatory responses which are scientifically sound, and regulatory compliant Provide scientific support expertise to unique activities related to respiratory clinical development plans to enable the execution of clinical studies.

Desired Candidate Profile

  • Overseeing the Clinical development programs worth value $10-20 Million 
  • Scientific support provided for 2-3 clinical trials 
  • Scientific support provided for an average of 8 -10 PK studies 
  • Support Regulatory submissions average of 5 -6 
  • Provide robust regulatory responses average 60-100 
  • 100% Regulatory compliance with respect to clinical study design

Qualification: M.B.B.S, MS/MD in Any Specialization

Location