392706BR
Apr 27, 2024
India
About the Role
Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clinical trial documentation and datasets. You will collaborate with colleagues from Statistics, Legal, Regulatory Affairs, Data Privacy, Data Management and Clinical Development and have the opportunity to support Read on for details about the role and how you can join a world-class organization at the forefront of the industry to advance your career.
To provide operational expertise in the mobilization of the organization’s commitment to sharing of clinical trial documentation and data sets; to work directly with project
teams to create and finalize clinical trial documentation and data sets for disclosure; to support and promote consistency with disclosure policies as set forth by the Clinical Disclosure Office and Data Privacy.
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
• Support the global cross-functional Transparency Submission Team to ensure all Clinical Transparency submission documents are delivered in accordance with timelines, high quality, operational and technical procedures.
• May attend Transparency Submission planning meetings with cross-functional team members to support the definition Transparency submission content.
• May contribute to pre-submission Health Authority Transparency In Scope Document books; applying lessons learned and potential efficiencies used successfully by other Transparency submission teams.
• Attend, as required, Transparency Submission Team meetings, to provide support regarding deliverable timelines; ensure timelines are in accordance with Novartis
processes.
• Perform as needed marking and redaction/anonymization of clinical trial documentation using appropriate tools.
• When required transfer the encrypted raw and analysis data via Intralinks or similar secure tool to Vendor and perform Acceptance
• Testing on all dataset deliverables received from Vendor, migrating completed anonymized datasets to GPS.
• Complete QC on vendor and Novartis deliverables for those projects assigned to.
• Support publishing, posting and archiving of clinical trial documentation and data sets for disclosure.
• Work with Transparency Management to track globally Health Authority requirements specific to the sharing of Clinical Trial data.
• Contribute to continuous improvement of submission processing
To provide operational expertise in the mobilization of the organization’s commitment to sharing of clinical trial documentation and data sets; to work directly with project
teams to create and finalize clinical trial documentation and data sets for disclosure; to support and promote consistency with disclosure policies as set forth by the Clinical Disclosure Office and Data Privacy.
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
• Support the global cross-functional Transparency Submission Team to ensure all Clinical Transparency submission documents are delivered in accordance with timelines, high quality, operational and technical procedures.
• May attend Transparency Submission planning meetings with cross-functional team members to support the definition Transparency submission content.
• May contribute to pre-submission Health Authority Transparency In Scope Document books; applying lessons learned and potential efficiencies used successfully by other Transparency submission teams.
• Attend, as required, Transparency Submission Team meetings, to provide support regarding deliverable timelines; ensure timelines are in accordance with Novartis
processes.
• Perform as needed marking and redaction/anonymization of clinical trial documentation using appropriate tools.
• When required transfer the encrypted raw and analysis data via Intralinks or similar secure tool to Vendor and perform Acceptance
• Testing on all dataset deliverables received from Vendor, migrating completed anonymized datasets to GPS.
• Complete QC on vendor and Novartis deliverables for those projects assigned to.
• Support publishing, posting and archiving of clinical trial documentation and data sets for disclosure.
• Work with Transparency Management to track globally Health Authority requirements specific to the sharing of Clinical Trial data.
• Contribute to continuous improvement of submission processing
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
WHAT YOU’LL BRING TO THE ROLE:
• Minimum university higher degree in life sciences/healthcare or equivalent with >4 years experience in the pharmaceutical industry and broad understanding of the drug development process.
• Solid knowledge of the emerging principles/guidelines governing clinical trial transparency, as well as a strong understanding of the driving forces and their associated perspectives.
• Strong, detailed understanding of the steps, roles and responsibilities in generating clinical trial
documentation, data sets, and submissions.
• Innovative critical thinking; detail-oriented yet pragmatic problem-solving skills.
• Excellent understanding of data privacy. Strong project management/organizational abilities to interface across line functions.
• Solid experience with vendor management.
• Good influencing and negotiating skills. Strong interpersonal and communication skills (verbal and writing) bridging scientific and business needs.
• Experience in process improvement initiatives.
Why Novartis?
766 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!
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
• Minimum university higher degree in life sciences/healthcare or equivalent with >4 years experience in the pharmaceutical industry and broad understanding of the drug development process.
• Solid knowledge of the emerging principles/guidelines governing clinical trial transparency, as well as a strong understanding of the driving forces and their associated perspectives.
• Strong, detailed understanding of the steps, roles and responsibilities in generating clinical trial
documentation, data sets, and submissions.
• Innovative critical thinking; detail-oriented yet pragmatic problem-solving skills.
• Excellent understanding of data privacy. Strong project management/organizational abilities to interface across line functions.
• Solid experience with vendor management.
• Good influencing and negotiating skills. Strong interpersonal and communication skills (verbal and writing) bridging scientific and business needs.
• Experience in process improvement initiatives.
Why Novartis?
766 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!
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Development
GCO GDD
India
Hyderabad, AP
Nov Hltcr Shared Services Ind
Research & Development
Full Time
Regular
No
