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

u2022 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.

u2022 Contributes to implementation of clinical protocols, and facilitates completion of final reports.

u2022 Recruits clinical investigators and negotiates study design and costs.

u2022 Responsible for directing human clinical trials, phases III & IV for company products under development.

u2022 Participates in adverse event reporting and safety responsibilities monitoring.

u2022 Coordinates and provides reporting information for reports submitted to the regulatory agencies.

u2022 Monitors adherence to protocols and determines study completion.

u2022 Coordinates and oversees investigator initiations and group studies.

u2022 May participate in adverse event reporting and safety responsibilities monitoring.

u2022 May act as consultant/liaison with other corporations when working under licensing agreements.

QUALIFICATIONS

Education Level Major/Field of Study or Equivalent

Associates Degree (u00B1 13 years)

Experience/Background

Minimum 4 years