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.
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)
**Required Skills: **
Audits Compliance, Audits Compliance, Biological Sciences, Biostatistics, Business English, Change Management, Clinical Knowledge, Communication, Conflict Resolution, Ethical Standards, Good Clinical Practice (GCP), Leadership Alignment, Legislative Monitoring, Medical Affairs, Medical Communications, Medical Review, Pharmacovigilance, Professional Networking, Quality Management Systems (QMS), Regulatory Compliance, Results-Oriented, Scientific Exchange, Stakeholder Engagement, Standard Operating Procedure (SOP) Management, Strategic Insights {+ 2 more}
**Preferred Skills: **
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Current Contingent Workers apply HERE
**Search Firm Representatives Please Read Carefully ** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status: **
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/14/2026
***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. **