Job Description

Job ID
368568BR

Mar 23, 2023

India

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\xe2\x80\x99s 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\xe2\x80\x99s 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 responsibilities include, but are not limited to:

• Act as subject matter expert for disclosure requirements on submission-related clinical trial documentation and data sets.
• Support regulatory communication about clinical trial documentation and data sets for disclosure.
• Support policy-specific scope identification of clinical trial documentation and data sets from submission deliverables.
• Provide project management for submission team assessment of in-scope documentation for commercially confidential information, sensitive company information, and potential copyright violation and the corresponding rationale.
• Perform as needed marking and redaction of clinical trial documentation using appropriate tools.
• Coordinate and QC vendor deliverables.
• Provide project management for project team review of vendor deliverables, feedback to vendor, and revision of vendor deliverables.
• Provide project management for project team preparation and finalization of justification tables and anonymization reports. Support publishing, posting and archiving of clinical trial documentation and data sets for disclosure.

Diversity & Inclusion / EEO

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

Minimum Requirements

• 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\xe2\x80\x99re proud of this, we know there is so much more we could do to help improve and extend people\xe2\x80\x99s 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\xe2\x80\x99s 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


Division
Global Drug Development
Business Unit
GDO GDD
Location
India
Site
Hyderabad, AP
Company / Legal Entity
Nov Hltcr Shared Services Ind
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No