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.

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)