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Senior Associate, Map & Psds Governance

Novartis
Novartis
2-4 years
preferred by company
PAN-India, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

Job Title: Senior Associate, MAP & PSDS Governance

Location: India
Job Type: Full-Time
Experience Required: 2–4 Years (Freshers are not eligible)
Industry: Pharmaceuticals / Medical Affairs / Clinical Operations / Drug Development / Healthcare Governance
Department: Governance / Managed Access Programs / Clinical Operations / Compliance

About the Role
We are seeking a highly analytical and detail-oriented Senior Associate, MAP & PSDS Governance to support global governance, compliance, and operational excellence initiatives related to Managed Access Programs (MAPs) and Post-Study Drug Supplies (PSDS) within a leading pharmaceutical organization.

This opportunity is ideal for professionals with experience in medical affairs, clinical operations, drug development, governance, or pharmaceutical compliance who are passionate about patient access, ethical governance, risk management, and quality systems.

The successful candidate will contribute to the development, implementation, and continuous enhancement of global governance frameworks, standards, policies, and risk mitigation strategies while collaborating with cross-functional global stakeholders across legal, compliance, quality, audit, and patient safety functions.

Key Responsibilities

Governance Framework Development & Process Management

  • Support the development, implementation, and maintenance of global governance frameworks for Managed Access Programs (MAPs) and Post-Study Drug Supplies (PSDS).
  • Assist in designing and maintaining internal standards, operational procedures, governance policies, systems, and process documentation aligned with global regulatory expectations.
  • Contribute to enterprise-wide governance oversight for assigned programs, processes, and services.
  • Support governance simplification and operational consistency across global and local teams.

Compliance, Risk Management & Quality Oversight

  • Identify governance, compliance, and quality risks associated with MAPs and PSDS operations.
  • Support implementation of risk mitigation strategies in collaboration with legal, ethics, compliance, audit, quality assurance, and patient safety teams.
  • Assist in maintaining robust internal controls to monitor compliance effectiveness and governance adherence.
  • Review audit observations, compliance findings, and governance risks while supporting remediation planning.

Audit Support & Corrective Action Management

  • Support global audit and inspection readiness initiatives across governance functions.
  • Assist in preparing documentation and responses for internal audits, quality reviews, and inspection activities.
  • Support country teams in managing corrective and preventive action (CAPA) plans following audit findings or compliance gaps.
  • Participate in governance reviews, self-assessments, and internal control evaluations.

Data Analysis & Governance Insights

  • Generate data-driven insights and governance reporting to improve oversight, compliance monitoring, and operational effectiveness.
  • Analyze trends, risks, performance indicators, and process adherence metrics across MAPs and PSDS activities.
  • Support decision-making through governance dashboards, reporting frameworks, and compliance intelligence.

Cross-Functional Collaboration & Stakeholder Engagement

  • Work closely with global stakeholders across medical affairs, legal, ethics, compliance, internal audit, quality assurance, patient safety, and country operations.
  • Support alignment between global governance expectations and local operational execution.
  • Build collaborative relationships with internal teams to strengthen governance maturity and quality culture.

Continuous Improvement & Change Management

  • Contribute to process improvement initiatives that enhance governance efficiency, compliance performance, and operational simplicity.
  • Support organizational change management initiatives promoting quality, ethics, compliance, and patient-centric operations.
  • Participate in global cross-functional projects focused on governance optimization and process excellence.

Required Qualifications

  • Master’s degree in Life Sciences, Clinical Operations, Pharmacy, Public Health, Biomedical Sciences, or related scientific disciplines.
  • 2–4 years of relevant pharmaceutical or public health industry experience in medical affairs, governance, clinical operations, compliance, or drug development.
  • Good understanding of pharmaceutical governance frameworks, quality systems, compliance controls, and operational risk management.
  • Experience working in matrix organizations and cross-functional global teams is preferred.
  • Strong analytical, documentation, reporting, and governance coordination skills.
  • Excellent communication, stakeholder engagement, and interpersonal collaboration abilities.
  • High ethical standards with a strong commitment to compliance, quality, and patient-centric decision-making.