About this role
JOB DESCRIPTION: MAIN RESPONSIBILITIES • As the Specialist in the Medical Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in overseeing the direction, planning, execution, clinical trials/research and the data collection activities. • Contributes to implementation of clinical protocols, and facilitates completion of final reports. • Recruits clinical investigators and negotiates study design and costs. • Responsible for directing human clinical trials, phases III & IV for company products under development. • Participates in adverse event reporting and safety responsibilities monitoring. • Coordinates and provides reporting information for reports submitted to the regulatory agencies. • Monitors adherence to protocols and determines study completion. • Coordinates and oversees investigator initiations and group studies. • May participate in adverse event reporting and safety responsibilities monitoring. • May act as consultant/liaison with other corporations when working under licensing agreements. QUALIFICATIONS Education Education Level Major/Field of Study or Equivalent Associates Degree (± 13 years) Experience/Background Experience Experience Details Minimum 7 years Licenses and Certifications Language Proficiency Language Proficiency The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Medical & Scientific Affairs DIVISION: EPD Established Pharma LOCATION: India > Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)