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Manager Study Governance

Manager Study Governance

NOVARTIS

5 - 10 years

7 - 12 Lacs

hyderabad

Posted:Just now| Platform:

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Skills Required

medical affairs manager internal audit change management manager quality assurance rcs compliance nis continuous improvement public health auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

About the Role

Join Novartis as Manager, Study Governance and play a crucial role in maintaining and enhancing standards, policies, guidelines, processes, systems, and tools for Non-Interventional Studies (NIS), Registries, Investigator Initiated Trials (IITs), Investigator Initiated Research (IIR), Local Interventional Studies (LIS), and Research Collaborations (RCs). You will implement risk mitigation plans in close collaboration with Legal, Ethics Risk & Compliance, Internal Audit, Quality Assurance, and Patient Safety, ensuring robust governance and continuous improvement across the organization.

Key Responsibilities

Maintain and enhance Novartis standards and manage the development of internal and external policies, guidelines, procedures, systems, and tools for NIS, Registries, IITs, IIR, LIS, and RCs in line with international guidelines and regulations.
Facilitate correct implementation of standards and tools at country organisations and global functions, providing enterprise-wide central governance and oversight.
Actively contribute to continuous improvement for assigned processes, products, and services, participating in cross-functional projects to simplify and improve adherence.
Demonstrate and act according to Novartis values and behaviours, supporting a culture of inspiration, curiosity, and self-awareness.
Support the development and delivery of training for associates and management to ensure adherence to standards, promoting collaboration through education and learning opportunities.
Identify quality and compliance risks for Novartis in assigned areas and establish mechanisms to mitigate these risks.
Promote change management and support a culture of quality, compliance, and patient centricity, identifying opportunities for global/local alignment.
Maintain and enhance internal controls to measure compliance, review audit outcomes, and support country self-assessments based on defined control matrices.
Maintain effective communication channels with Novartis teams and present to management as requested.
Support country organisations in setting up and executing corrective and preventive action plans in response to audit or inspection findings.

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

Essential Requirements

Master s degree in science; Doctor of Medicine (M.D.) or Pharm D. is a plus.
Approximately 5 years relevant work experience within clinical settings, public health, or the pharmaceutical industry (e.g., medical affairs, drug development, patient safety, quality, or compliance).
Strong technical knowledge in governance areas relevant to the role.
Excellent interpersonal skills, demonstrating collaboration, quality, and integrity; ability to bridge scientific and business experts.
Experience working in matrix teams in global organisations and project teams.
High learning agility, comfortable with complexity and diversity, and a strong interest in continuous improvement.
Excellent communication skills across different audiences and organisational levels.
Excellent English language skills, both written and spoken.

Desirable Requirements

External orientation and awareness of industry trends.
Excellence in designing and continuously improving business processes to meet quality and compliance standards and simplify ways of working.

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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Manager Study Governance