About the role
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/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:Medical & Scientific AffairsDIVISION:EPD Established PharmaLOCATION:India > Mumbai : BKC BuildingADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Not specifiedMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)