Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

The Section Head Medical Affairs is responsible for leading a therapeutic or functional area within the Medical Affairs department. This role ensures the development and execution of medical strategies, scientific communication, evidence generation, and stakeholder engagement to support the safe and effective use of BBLs products. The role also ensures compliance with regulatory standards and alignment with commercial and clinical objectives.

Key Responsibilities

Strategic Medical Leadership

Develop and implement medical strategies for assigned therapeutic areas or product portfolios.

Align medical plans with corporate, regulatory, and commercial objectives.

Provide scientific leadership in crossfunctional teams including RD, Regulatory, Pharmacovigilance, and Commercial.

Scientific Communication Medical Information

Oversee the development of scientific content including publications, slide decks, and medical education materials.

Ensure accuracy, compliance, and alignment of all medical communications with regulatory and ethical standards.

Support internal training for field medical teams and commercial staff.

Evidence Generation RealWorld Data

Lead or support postmarketing studies, Phase IV trials, and realworld evidence RWE initiatives.

Collaborate with clinical research and external partners to generate data that supports product value and safety.

KOL Stakeholder Engagement

Build and maintain relationships with key opinion leaders KOLs, investigators, and healthcare professionals.

Organize advisory boards, scientific symposia, and expert panels to gather insights and disseminate scientific knowledge.

Regulatory Compliance Support

Ensure all medical affairs activities comply with global and local regulatory requirements e.g., GxP, ICHGCP.

Review and approve promotional and nonpromotional materials for scientific accuracy and compliance.

CrossFunctional Collaboration

Work closely with Market Access, Commercial, and Regulatory teams to integrate medical insights into business strategies.

Contribute to the development of value dossiers, HTA submissions, and payer engagement materials.

Team Leadership Development

Lead, mentor, and develop a team of medical professionals including MSLs, medical writers, and scientific advisors.

Foster a culture of scientific excellence, compliance, and continuous learning.