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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: Minimum: Master’s degree (MA/MS) in Medicine, Neurology, Psychology, or related field. Preferred: MD, DO, or PhD. Skills: Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man

Job Title: Senior Associate – MAP & PSDS Governance

Company: Novartis
Job ID: REQ-10075959
Location: India
Employment Type: Full-Time
Industry: Pharmaceuticals / Medical Affairs / Clinical Operations / Governance / Drug Development / Compliance

Job Overview

We are seeking a Senior Associate – MAP & PSDS Governance to support global governance, compliance oversight, policy implementation, quality risk management, and process excellence for Managed Access Programs (MAPs) and Post-Study Drug Supplies (PSDS).

This role is ideal for professionals with experience in medical affairs, clinical operations, drug development, governance, quality compliance, audit readiness, and pharmaceutical operational excellence.

The successful candidate will support enterprise-wide governance frameworks, quality controls, compliance risk mitigation, audit readiness, and continuous process improvement while collaborating with global stakeholders across the pharmaceutical ecosystem.


Key Responsibilities

Governance Framework Support

  • Support development, implementation, and maintenance of global governance frameworks for:
    • Managed Access Programs (MAPs)
    • Post-Study Drug Supplies (PSDS)
  • Help establish enterprise-wide oversight mechanisms for assigned processes, products, and governance services.
  • Ensure governance frameworks align with internal standards and regulatory expectations.

Standards, Policies & Process Management

Support creation and maintenance of:

  • Global standards
  • Internal policies
  • External compliance guidelines
  • Standard operating procedures (SOPs)
  • Governance tools
  • Systems and process documentation

Ensure alignment with:

  • International guidelines
  • Applicable pharmaceutical regulations
  • Organizational governance expectations

Compliance & Risk Management

  • Support identification of compliance and quality risks related to MAPs and PSDS operations.
  • Assist in developing and implementing mitigation mechanisms for identified risks.
  • Help strengthen governance controls and operational oversight.

Collaborate with:

  • Legal
  • Ethics Risk & Compliance
  • Internal Audit
  • Quality Assurance
  • Patient Safety

Data Analytics & Governance Insights

  • Generate data-driven governance insights from MAP / PSDS operations.
  • Analyze trends, performance indicators, and compliance outcomes.
  • Support governance optimization through operational intelligence.

Continuous Improvement

  • Contribute to process improvement initiatives across governance operations.
  • Participate in cross-functional transformation projects aimed at:
    • Better compliance adherence
    • Operational simplification
    • Governance effectiveness
    • Standardization improvements

Change Management & Quality Culture

  • Support organizational change initiatives promoting:
    • Quality culture
    • Compliance awareness
    • Patient-centric decision making
    • Global/local governance alignment
  • Identify improvement opportunities across regional and global processes.

Internal Controls & Compliance Monitoring

Support maintenance and enhancement of internal control mechanisms including:

  • Compliance measurement frameworks
  • Governance control matrices
  • Monitoring mechanisms
  • Process adherence reviews

Responsibilities include:

  • Country exchanges
  • Self-assessment coordination
  • Governance reviews

Audit & Inspection Readiness

  • Support preparation for:
    • Internal audits
    • Quality audits
    • Inspections
    • Compliance assessments
  • Review audit findings and governance observations.
  • Assist in remediation planning and compliance follow-up.

CAPA Support

  • Support country teams in developing and executing:
    • Corrective Action Plans (CAPA)
    • Preventive Action Plans

Especially for:

  • Major audit findings
  • Inspection observations
  • Governance compliance gaps

Global Stakeholder Collaboration

Work with global stakeholders across:

  • Medical Affairs
  • Clinical Operations
  • Drug Development
  • Compliance
  • Legal
  • Patient Safety
  • Quality Assurance
  • Internal Audit
  • Country organizations

Drive collaboration in matrix environments.


Governance Compliance

  • Adhere to organizational policies, procedures, training requirements, and ethical standards.
  • Support governance excellence aligned with enterprise expectations.

Required Qualifications

Education

Master’s Degree in:

  • Science
  • Clinical Operations
  • Life Sciences
  • Pharmacy
  • Related healthcare/scientific disciplines

Experience Required

  • 2–4 years of relevant pharmaceutical / public health experience

Preferred backgrounds:

  • Medical Affairs
  • Clinical Operations
  • Drug Development
  • Governance / Compliance
  • Quality Operations