Job Description

About the role

Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working.

The Head Clinical Document Management (CDM) Process drives the tactical implementation of the Clinical Document Governance Management (CDGM) strategy to meet immediate needs and evaluate future strategies to build on, ensuring Novartis is in a strong position to deliver Trial Master Files for all studies in a simple, consistent, sustainable way aligned with international regulatory expectations. We are changing and future proofing how we handle Trial Master Files to become the industry gold standard in enabling Novartis deliver at scale with sustainable speed.

Your responsibilities will include:

• Leads the delivery of innovative and efficient operational support for the assigned unit(s)
• Responsible for strategy implementation
• Responsible for initiating and driving critical programs and initiatives within own team and/or matrix community
• Leads operational excellence initiatives. Drives continuous improvement and provides deep insight with collaborators within area of expertise
• Liaises with other areas of the business providing senior input and advice to global projects. Acts independently to determine methods and procedures on new or special projects/assignments.
• Leads and works with own team to build scientific/ technical expertise. Contributes to long-term talent and succession planning
• Responsible for initiating and driving critical programs and initiatives within own team
• Accountable for success of project goals, cross-divisional and/or external collaborations within direct and indirect team

The position location can be flexible to include Switzerland, Ireland, India, UK (Remote) & US and as such, similar job postings will be advertised.

Role Requirements

What you\'ll need:

• University degree (e.g. BSc, RN) and relevant industry experience or equivalent. Advanced degree is desirable (e.g. MSc, MPH, MBA, PhD)
• Fluent proficiency in English language written and oral
• Minimum of 10 years\' experience working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience in clinical documentation and/or records & information management.
• 3+ years\' experience in direct people management or matrix management of project/clinical teams.
• Deep understanding of drug development process, international drug approval procedures and standards (e.g. ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management (e.g. DIA TMF reference model).
• Proven success in planning and executing cross functional change projects.
• Strong influencing and presentation skills.
• Ability to communicate effectively at all levels.
• High organisational awareness in multi-disciplinary teams, across cultures and geographies.
• Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.

You\'ll receive:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why Novartis?
743 million lives were touched by Novartis medicines in 2021, and while we\'re proud of this, we know there is so much more we could do to help improve and extend people\'s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned
by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Functional Area

Research & Development

Division

Global Drug Development

Business Unit

GCO GDD

Employment Type

Regular

Commitment to Diversity & Inclusion:

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

Shift Work

No

Early Talent

No

Novartis