Medical Services Director

Job Description

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

. It oversees medical review activities for promotional and external materials, disease awareness campaigns, and other product- or therapy area-related communications, while also serving as the accountable leader for the local Designated Point of Contact for medical, safety, and product quality inquiries. In addition, this role leads and develops a team by fostering a collaborative, inclusive, and high-performing environment grounded in constructive feedback, effective delegation, and strong interpersonal awareness.

Primary Activities include but are not limited to:

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

Is responsible for periodic reporting of Designated Point of Contact and Medical Information performance and quality.

Is 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.