MEDICAL AFFAIRS ANALYST

Job description

General Summary

Compliance guidance and requirements execution efforts for activities and processes related to Medical Affairs Area in Latin America.

The Medical Affairs Specialist II will work in partnership with other internal areas, such as Business Quality, IPV, Center of Excellence, Global Clinical Operations Medical Affairs Operation (GCO-MAO), Real World Evidence (RWE), Information Technology (IT) and Medical Affairs ensuring that the activities are managed in compliance with local regulations and company policies/procedures at a local, regional and global level.

Duties & Responsibilities

The following processes and activities fall under the direct responsibilities of this position:

-Development periodic reports related to Medical Affairs area and activities to provide metrics and inputs for the Region;

-Pre-audit preparation, audit support and management of corrective actions, preventive actions and effectiveness check as post-audit activity related to Medical Affairs Area;

-Management of the core curriculum of Medical Affairs employees in the company systems;

-Provide a support in the onboarding process of regional Medical Affairs employees;

-Develop and apply trainings for Medical Affairs employees and monitor training completion metrics;

-Ensure that Medical Affairs documents will be reviewed periodically and approved in the appropriate company system;

-Identify gaps and/or improvements opportunities and work with the team to determine the adequate handling of an activity, stablish applicable actions to avoid re-incidence issues and document the process properly;

-Perform a monthly quality control of the main activities executed by Center of Excellence team;

-Support for systems implementation, updates and alignments and act as Administrator of Medical Affairs related systems applicable to Medical Compliance area;

-Act as a member of the regional committee to evaluate and discuss new concepts proposals of clinical trials and unsolicited requests initiatives to provide Compliance direction and orientation;

-Work closely with the Medical Compliance Coordinator in the conduction of the activities from Medical Compliance area and demands that can came from RWE and GCDO-MAO teams.

Desired profile

Qualifications :

Any Health care career, with oral and written proficiency in English and in Spanish.