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53942939 Transparency Manager - East Hanover, NJ

Job Information

ID :
#35916175
# of Positions :
1
Minimum Education Level :
Unspecified
Experience Required :
3+ years
Duration :
Full Time Regular
Shift :
Unspecified
Hours per week:
40

Job Description

 

Job ID
317971BR
Transparency Manager

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.

EEO Statement
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!
Division
Global Drug Development
Business Unit
GDO GDD
Country
USA
Work Location
East Hanover, NJ
Company/Legal Entity
Novartis Pharmaceuticals
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No

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 any other employment
practices for reasons of race, color, religion, gender, national origin,
age, sexual orientation, marital or veteran status, disability, or any
other legally protected status.

Company Information

Name :
Description :

Novartis Group Companies

Our mission

Our mission is to care and cure. We want to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life.


Healthcare portfolio

Novartis has five business segments and is supported by our global research organization, the Novartis Institutes for BioMedical Research (NIBR). These segments are strategically aligned to bring innovative, high-quality and affordable medicines and therapies to patients around the world.


People

We strive to provide our associates with the safest possible workplace and to promote their health and well-being. We are an integral part of the communities that host our operations. We pay living wages worldwide, contributing to the stability and prosperity of these communities.


Collaborations

At Novartis, we often achieve success through close collaboration with partners who share a common vision and complementary strengths.

Type :
Direct Employer
Address :
230 Park Ave
New York, NY 10169

Application Information

Online :
Job Posting Entered On :
4/27/2021
Job Posting Expires On :
7/26/2021