The Medical Affairs Manager will provide strong support to Medical Affairs Director in managing Medical Affairs operations related to compliance to medical ethical & regulatory standards.
Key Areas of Responsibilities:
- Compliance – Promotions Approval: Reviews promotional materials to ensure compliance with regulations and guidelines, and claims are accurate with scientific merit and validity.
- Medical-Marketing Alignment & Cross-functional collaboration: Provides medical inputs for Brand Strategy formulation & Message Management, participates in the scheduled Medical Coordination Meetings with relevant medical/clinical information for discussion and decision-making, contributes in the development of CME modules, Brand training modules, Engages in scientific discussions with national key opinion leader networks, organizes and participates in advisory boards
- Medical Information Service / New Product Evaluation: Provides appropriate response to medical information queries from internal/external customers, health authorities, others; Evaluates business development opportunities together with BD, from a medical standpoint
- Clinical Research: Acts as lead during the conduct of company-initiated clinical studies to ensure adherence to GCP and Regulatory standards.
- Pharmacovigilance: Responsible for reporting AEs on their assigned brands to PV lead for further processing.
Position Qualifications:
- Degree in Doctor of Medicine. Internal Medicine graduate preferred.
- At least three (3) years related experience in a pharmaceutical industry
- Strong background in clinical research