Senior Transparency Associate

4 weeks ago

Hyderabad, India Novartis India Full time

Position Title :

Senior Transparency Associate


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


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.

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