Job Description Summary
Responsible for leading the GCC-based delivery and oversight of worldwide post-approval data generation (DG), worldwide compassionate use (CU) as well as for the Global and Region Europe Medical Affairs team Medical Legal Regulatory (MLR) operations, HCP Engagement operations, and Early Program Biosimilar Pipeline Support with all related responsibilities within the Medical Excellence Operations organization. The role ensures high-quality, compliant, and efficient service delivery, drives process consistency and operational governance, and partners with Global Medical Affairs and cross-functional stakeholders to ensure operational delivery, capability building, performance visibility, and continuous improvement.Job Description
Responsible for leading the GCC-based delivery and oversight of worldwide post-approval data generation (DG), worldwide compassionate use (CU) as well as for the Global and Region Europe Medical Affairs team Medical Legal Regulatory (MLR) operations, HCP Engagement operations, and Early Program Biosimilar Pipeline Support with all related responsibilities within the Medical Excellence Operations organization. The role ensures high-quality, compliant, and efficient service delivery, drives process consistency and operational governance, and partners with Global Medical Affairs and cross-functional stakeholders to ensure operational delivery, capability building, performance visibility, and continuous improvement.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Drive compliance, quality, and process discipline for post-approval data generation (DG) and compassionate use (CU) activities, including adherence to applicable SOPs / working practices, issue/risk identification, and remediation support where needed. Lead end-to-end delivery and operational oversight of post-approval data generation, including management of global study review, governance and oversight of DG projects to ensure Health Authority inspection readiness. Supports execution of joint-PASS.
Lead end-to- operational oversight of compassionate use requests to ensure Health Authority inspection readiness. DG, CU and Publication System super users deliver the defined support for Medical Affairs associates and Technology.
Lead delivery and operational oversight of MLR support services, including workflow coordination, submission support, metadata / documentation discipline, user enablement, super user role, and process consistency. Lead end-to-end delivery and operational oversight of HCP Engagement support services, including coordination of contracting-related workflows, documentation, reporting support, invoicing, eCORE support and super user role and associated operational controls. Function as Training Responsible Person (TRP) for Global and Regional Medical Affairs associates. Create Shopping Carts (SCs) and support with other finance related topics. Oversee Early Program Biosimilar Pipeline Support activities, including medical writing, desk research / competitive intelligence, analytical support, and synthesis of insights into fit-for-purpose outputs such as summaries and slide decks.
Ensure effective prioritization and resourcing across a diverse portfolio of workflow-driven and specialist support activities, while maintaining quality and timeliness of delivery. Drive process discipline, documentation quality, onboarding / training support, and knowledge sharing across the team and relevant stakeholders. Partner with Global Medical Affairs, business owners, agencies, legal / compliance-related stakeholders, and other functions to align requirements, resolve issues, and improve ways of working.
Support the transition and stabilization of services into GCC and contribute to process standardization, documentation, and operational maturity.
Key Performance Indicators: DG, CU, MLR, HCP Engagement, TRP, SC and Early Program support services are delivered effectively and in line with agreed quality, timeliness, and stakeholder expectations.
Team delivery is consistent, well-coordinated, and supported by appropriate process documentation, training, and operational controls.
Service metrics, quality indicators, and issue trends are monitored and used proactively to improve delivery and stakeholder experience. Functional risks / gaps are identified early and addressed through practical mitigation and continuous improvement actions.
What you’ll bring to the role:
Essential Requirements:
Education: Advanced degree or equivalent qualification in life science, healthcare, pharmacy, medicine, or related field preferred.
12-15+ years experience in the pharmaceutical / healthcare industry, ideally with exposure to Medical Affairs operations, DG, CU, MLR / content workflows, HCP engagement processes, training and/or related operational support models.
Strong experience in cross-functional coordination, workflow-driven execution, and stakeholder management across multiple service lines.
Experience leading teams and driving delivery both structured operational work and specialist analytical / writing support.
Experience in process improvement, training / onboarding enablement, and service quality management is preferred.
Strong communication, presentation, and people leadership skills in a global environment.
Resilient and agile, with strong prioritization skills and a passion for simplification.
Why Sandoz?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
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
Agility, Agility, Clinical Practices, Cross-Functional Collaboration, Data Analysis, Drug Development, Employee Development, Healthcare Sector Understanding, Health Sciences, Influencing Skills, Innovation, Inspirational Leadership, Integrated Evidence Generation, Medical Affairs, Medical Communication, Medical Education, Patient Care, People Management, Pharmaceutics, Priority Disease Areas Expertise, Product Launches, Product Strategy, Real World Evidence (RWE), Regulatory Compliance, Research Methodologies {+ 3 more}