Medical Governance & Evidence Lead

Job Description Summary

#LI-Hybrid
Location: Bucharest, Romania

The Medical Governance and Evidence Lead oversees country-level medical governance, evidence generation, medical operations and medical customer and field excellence activities to ensure the highest standards of quality, compliance, scientific rigor and operational excellence across Medical Affairs. The role ensures strong governance, effective evidence planning and harmonized ways of working, while partnering closely with cross‑functional, regional and global stakeholders to deliver compliant, patient‑centric outcomes.

 

Job Description

Key responsibilities

• Ensure end-to-end medical governance by overseeing compliance with Novartis good practices, local regulations, global standards and audit requirements.

• Maintain high performance of medical operations, medical information, MAPs, field medical excellence and evidence generation activities across therapeutic areas.

• Partner closely with Legal, Regulatory, ERC and Pharmacovigilance to uphold ethical standards and compliance in all medical activities.

• Continuously review SOPs, audit findings and governance processes, driving harmonization, process improvements and operational excellence.

• Act as the local point of contact to regional, international and global medical governance and evidence teams, ensuring aligned ways of working.

• Drive medical customer and field excellence by enabling harmonized processes, performance metrics tracking and capability building for field medical teams.

• Monitor medical performance and effectiveness metrics using company tools and define improvement plans in collaboration with excellence teams.

• Lead and oversee local evidence generation activities including observational studies, RWE programs and local clinical studies.

• Ensure effective planning, execution, budget oversight and vendor management for medical evidence generation activities.

• Provide strategic medical governance guidance to support regulatory readiness, operational improvement and consistent country Medical Affairs performance.

Requirements

• University degree in science, pharmacy or health sciences, fluency in English and local language, with 4–7 years of experience in Medical Affairs.

• Proven experience designing, implementing and harmonizing medical governance and operational processes.

• Strong background in continuous process improvement, SOP governance and operational standardization.

• Experience with field medical excellence programs, capability building and performance metrics tracking.

• Hands-on experience planning, executing or overseeing observational studies, RWE programs or local clinical studies.

• Strong understanding of evidence planning, study startup processes, timelines, budget oversight and vendor management.

• Demonstrated experience ensuring audit readiness, managing audit findings and implementing corrective action plans.

• Strong analytical skills with ability to interpret evidence, evaluate process performance and make data-driven decisions.

• Proven ability to lead and influence cross-functional stakeholders without direct authority.

• Experience collaborating with regional and international medical teams and acting as a governance point of contact.

• Excellent communication skills with the ability to simplify complex medical, evidence and governance topics.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

 

Skills Desired

Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Internal Medicine, Job Description, Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)