Senior Associate Transparency Specialist
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 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 university higher degree in life
sciences/healthcare or equivalent with >2 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
• 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.
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
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
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