Global Drug Development

Global Drug Development (GDD) is responsible for advancing the Novartis pipeline of investigational medicines to bring transformative new treatment options to patients with serious diseases. GDD leads the clinical development of potential new medicines, running large clinical trials and steering the path to regulatory approval, while also maintaining oversight of ongoing patient safety and regulatory activities for licensed therapies.

Meet the teams:

Global Clinical Operations (GCO) is the bridge that turns great science into great medicine. We provide clinical trial operations services to the divisional development teams, taking the compounds developed by our colleagues and test those compounds in clinical trials.

We have more than 5,000 colleagues working across more than 60 countries, working in specialized core functions for end-to-end trial operations management:

  • Trial Management
  • Trial Monitoring
  • Data Operations
  • Regulatory Writing and Submissions (RWS)
  • Strategic Planning and Feasibility

 And dedicated capabilities to drive continuous improvement:

  • Transformative Business Operations
  • Risk Management
  • External Development Operations (EDO) for vendor management
  • Strategy and Integration
  • Clinical Innovation and Technology
  • data42

These focus areas, combined with our use of advanced technology and data analytics allow us to make informed decisions, potentially resulting in new, life-changing therapies for patients globally.

The Novartis Group’s Chief Medical Office and Patient Safety organization is an integrated team which provides Novartis-wide oversight and governance of patient focused activities including Patient Safety, Pharmacovigilance, Device-vigilance as well as Ethical, Regulatory and Reputational issues. We support our company mission by further strengthening our focus on patients and providing patient-centric solutions and outcomes by:

  • Establishing a single Chief Medical Office for Novartis for all patient related policy and standards
  • Creating one single Safety/pharmacovigilance organization across all divisions and one harmonized Product Stewardship team
  • Integrating all country level Pharmacovigilance and Device vigilance into a single organization
  • Implementing and deploying the Novartis Patient Declaration across the Group
Giselle, Patient Safety Specialist

4 years with Novartis. From an intern to HR Analyst and Patient Safety Specialist. Novartis offers us the flexibility to drive our own career. There are many growth opportunities here, and innovation and thinking-outside-the-box mindset is actively encouraged, even when it comes to your career development.

Giselle,Patient Safety Specialist

Regulatory Affairs (RA) is a unified, diverse, and strategic company-wide team. We are passionate about delivering regulatory excellence and innovation beyond traditional boundaries to enable timely and sustainable access to superior products for patients worldwide. Careers in RA offer the ability to gain real breadth of experience across many therapeutic areas as well as depth of experience and knowledge.


We in the Technical Research & Development (TRD) team are responsible for developing innovative technical product designs and robust, scalable manufacturing processes.

We are responsible for the manufacture and supply of all pre-clinical and clinical study materials across all stages of clinical and pharmaceutical development. We add value by working with and enabling a broad spectrum of cross-divisional partners, including early Research teams (see Research) late phase Development and registration teams, our commercial manufacturing teams, (see Technical Operations) and our Generics development teams. 

Given this huge breadth of areas covered by TRD, we as associates benefit from one of the strongest possible learning environments and professional, career development opportunities.

We have an impact on a variety of other Novartis functions too. As a team of 2500 associates we work across 4 continents and 8 countries, developing practically the entire Novartis portfolio, across all Disease areas, including cutting edge Cell and Gene therapies.

Our aim is to be partners in efficient program execution and to promote opportunities that increase the value of our pipeline for our patients and stakeholders.

Strategy, Program & Portfolio Operations (SPPO)

Clinical Development & Analytics (CD&A) is an integrated global line function delivering clinical, biostatistical, advanced analytical and functional excellence in integrated drug development.

We are organized around the following 4 key areas:

  • Therapeutic Areas (TAs) across the Development Units and Sandoz Biopharmaceuticals
  • Analytics function comprised of the Biostatistics and Pharmacometrics groups
  • China Development and Japan Clinical Development
  • Central Team comprised of Clinical Sciences, Pediatric Centre of Excellent, PRO Centre of Excellence and Strategy & Operations groups

CONEXTS

CONEXTS is a solutions partner that creates value for the larger enterprise through our highly specialized/ skilled teams. Within CONEXTS the Medical and Clinical Solutions team support internal business stakeholders with:

We provide end-to-end solutions in the communication and dissemination of scientific data and information for Medical Affairs, Regulatory and Clinical groups as well as external audiences. Our services cover Scientific Writing - Publications & Medical Education, Medical Advisory, Medical Information, Scientific Events & Congresses.

We provide technical services in clinical trials and medical activitiesfor Global Drug Development, Global Medical Affairs, Innovative Medicines US, NIBR and countries.

In Biometrics, we provide clinical data related services for clinical trials and scientific analysis by leveraging statistical, programming, medical writing and data management expertise.

For Trial and Medical Operations, our areas of expertise include Clinical Project Management, Digital Endpoints, Managed Access Programs, Research Collaborations and Medical Program Operations.

We partner with Evidence Generation, HEOR and Patient Access teams to deliver "real world" secondary data to support evidence generation for launch and on market brands. We also provide Scientific and data analytics to support integrated Evidence Plans, regulatory and payer submissions.

We are the electronic library for Novartis, responsible for e-license and license management. We also provide high quality published scientific, technical, medical and business information across all of Novartis. Specific services include media monitoring, knowledge management and copyright.

Delivering analytics, data and digital solutions, field force support globally, and enabling access for patients to our treatments.

Supporting on contract management, transparency, and legal, compliance and risk operations.

Spanning project and change management to process optimization.

Why CONEXTS?

In addition to the thousands of training opportunities available, as part of smaller team there is greater visibility for your knowledge, skills and deliverables while working on valuable medical projects and services.


 

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