Transparency Manager

317971BR
Apr 27, 2021
USA

Job Description

799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
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.
1. Act as subject matter expert for disclosure requirements on submission-related clinical trial documentation and data sets.
2. Support regulatory communication about clinical trial documentation and data sets for disclosure.
3. Support policy-specific scope identification of clinical trial documentation and data sets from submission results.
4. Provide project management for submission team assessment of in-scope documentation for commercially confidential information, critical company information, and potential copyright violation and the corresponding rationale.
5. Perform as needed marking and redaction of clinical trial documentation using appropriate tools.
6. Coordinate and QC vendor results.
7. Provide project management for project team review of vendor results, feedback to vendor, and revision of vendor results.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

Requirements:
• Minimum university higher degree in life sciences/healthcare or equivalent.
• >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.
Why consider Novartis?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Global Drug Development
GDO GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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317971BR

Transparency Manager

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