Senior Associate - Managed Access Programs and Post-Study Drug Supplies Governance

Senior Associate, MAP & PSDS Governance

Job Description Summary

Independently support development, implementation and maintenance of global standards, policies, guidelines, processes, systems and tools for Managed Access Programs (MAPs) and Post-Study Drug Supplies (PSDS) and their global governance framework.
Support implementation of risk mitigation plans in close collaboration with Novartis Legal, Ethics Risk & Compliance, Internal Audit, Quality Assurance and Patient Safety.

Job Description

Major accountabilities:

• Support the development, implementation and maintenance of Novartis global standards for Managed Access Programs (MAPs) and Post-Study Drug Supplies (PSDS), their internal and external policies, guidelines, procedures, systems and tools according to international guidelines and applicable laws and regulations

• Generate data‑driven insights from MAPs/PSDS to optimize governance

• Support the development and implementation of a global governance framework enabling enterprise-wide central governance and oversight for assigned processes, products and services

• Contribute to continuous improvement for assigned processes, products and services; participate in cross-functional projects to continuously improve Novartis standards, policies, guidelines, processes and systems to ensure better process adherence and to simplify the way we work

• Support identification of quality and compliance risks for Novartis related to assigned areas and establish mechanisms to mitigate these risks

• Support change management and a culture of quality, compliance and patient centricity; identify opportunities for global/local alignment

• Support maintenance and enhancement of internal controls to measure compliance; review internal audit outcomes, perform country exchanges and support country self-assessments based on defined control matrices

• Support country organizations to set-up and execute appropriate corrective and preventive action plans in case of major audit or inspection findings

• Support global inspection and audit preparation and conduct for quality and internal audits. Support corrective actions as required

• Adhere to Novartis values and behaviours, policies, guidelines, procedures, trainings

Minimum Requirements:

• Master’s degree in science or clinical operations

• Relevant work experience (approx. 2-4 years) in the pharmaceutical industry or public health sector, in medical affairs, clinical operations or drug development. Good knowledge in relevant governance area

• Good interpersonal skills demonstrating the Novartis values for collaboration, quality and integrity

• Experience in working in matrix teams in global organizations and global project teams

• Good communication skills across different audiences and organizational levels

• Ability to build relationships with internal and external stakeholders

• Openness to change and a culture of high ethical standards and compliance

Skills Desired

Clinical Research, Clinical Trials, Curious Mindset, Databases, Drug Development, Job Description, Lifesciences, Medical Communication, Medical Information, Medical Writing, Military Intelligence, Patient Care, Physics, Technical Support

Experience Level

Senior Level