Medical Services Director

Overview

This role is responsible for ensuring the scientific, ethical, and regulatory integrity of all medical-scientific information activities within the company, in full compliance with AIFA regulations, the Farmindustria Code of Ethics, and internal policies.

Responsibilities

• Medical Process and Quality Management – Ensures that local Medical Affairs procedures and guidelines are constantly updated, optimized, and in compliance with all relevant regulations and standards (Italian and European regulations, Italian Ministerial or Medicines Authority provisions, Pharmaceutical Industry associations’ or other practice guidelines, and our company's ethical standards, policies, procedures or specific directives). Supports Medical Affairs colleagues or other functions to ensure alignment to Pharma Code and Law for the local procedures and guidelines involving medical processes. Monitors local processes in terms of actual practice, performance and compliance to regulations. Monitors and alerts about any changes in legislation or practice guidelines relevant to medical processes. Provides assistance to the preparation of process and system quality audits involving Medical Affairs, as well as to the implementation of medical processes. Makes strategic plans in order to strive for a continuous improvement of medical processes and promptly respond to regulatory or policy changes. Build and maintain contacts with appropriate/relates our company's functions, both at a global level and within subsidiaries in EU Countries.
• Designated Point of Contact / Medical Information Activity – Ensures that medical inquiries (professional information requests and patient/customer inquiries) receive prompt attention and appropriate responses are delivered (consistent, accurate, complete, up-to date and specific). Oversight of all Medical Information activities, including written and verbal responses, medical information letters, and scientific Q&A documents. Ensuring scientific accuracy, consistency, and regulatory compliance of all medical information provided to external stakeholders. Generation of strategic insights from Medical Information activities to support Medical Affairs strategy.
• Medical Review Activity – Responsible for periodic reporting of Designated Point of Contact and Medical Information performance and quality. Responsible for adequate and timely medical review of promotional or other material in accordance with all relevant regulations and standards (Italian and European regulations, Italian Ministerial or Medicines Authority provisions, Pharmaceutical Industry associations’ or other practice guidelines, and our company's ethical standards, policies, procedures or specific directives), for all products or specific disease within the therapeutic areas. Supervision of promotional material review and approval processes, ensuring segregation of duties, traceability, and audit readiness. Close collaboration with Compliance, Regulatory, and Legal functions to ensure full regulatory compliance.

Job Requirements

• Education
• Degree in Medicine, Pharmacy, Chemistry and Pharmaceutical Technologies (CTF), Biology, or related scientific disciplines mandatory
• In‑depth knowledge of Italian pharmaceutical regulations (AIFA, Farmindustria Code, Legislative Decree 231/01 and 219 etc…)
• Knowledge of good clinical practices and Good Pharmacovigilance practice
• In‑depth knowledge of Legal and Compliance pharmaceutical regulations
• Medical Doctor qualification is highly valued and represents a strong advantage for the role.

• Skills
• Communication skills (Both written and spoken)
• Process and workflow analysis and optimization
• Problem Solving and decision‑making capabilities
• Team work, Leadership and Coordination, conflict handling, planning
• Fluent English (written spoken)
• Business Perspective

• Experience
• It is mandatory that candidates have actively performed this role within the last three years (applications from individuals whose experience falls outside this timeframe will not be considered)
• Scientific responsible as per local requirements (mandatory)
• Quality control or quality assurance (3 years desirable)
• Clinical trials
• Audit and/or Inspection management
• Pharmacovigilance (basic experience)

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