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 role can be based in either in Dublin, United Kingdom (remote) or Hyderabad/Mumbai.

　　Diversity & Inclusion / EEO

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

　　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.

　　Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

　　You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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

　　Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

　　Division

　　Development

　　Business Unit

　　GCO GDD

　　Location

　　United Kingdom

　　Site

　　National

　　Company / Legal Entity

　　Novartis Pharmaceuticals UK Lt

　　Alternative Location 1

　　Ireland

　　Alternative Location 2

　　India

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No