Senior Manager Medical Affairs

JOB DESCRIPTION:

MAIN PURPOSE OF THE ROLE

Leads/supervises a team of more than 2 professionals within the Medical Affairs Sub-Function.

First level manager of a work team that may comprise professionals, technical and/or administrative staff.

Typically without budget or hire/fire authority.

Focuses on mentoring, coaching, and coordination.

MAIN RESPONSIBILITIES

As the Supervisor of the Medical Affairs Sub-Function, supervises professionals 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 Level Major/Field of Study or Equivalent

Associates Degree (± 13 years)

Experience/Background

Minimum 4 years

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)