Experienced in document quality management? Don't miss this fantastic opportunity!

About the role:
In this key role, you will perform assessment, quality control and publishing of NIBR scientific documents to ensure consistency with source data and to achieve the technical quality to comply with internal and external guidelines and requirements. The successful candidate will oversee external service providers as related to areas of responsibility. You will also collaborate to support timely compilation of high-quality submissions for Global Health Authorities.

Your responsibilities include, but are not limited to:

• Perform source data verification (SDV) and technical (Novstyle) quality control (QC) of NIBR submission documents (simple to medium complexity) to ensure both content and format fulfil requirements. Collaborate with globally located NIBR scientific personnel to ensure finalization of the documents, according to timelines and quality requirements.
• Compile, integrate and publish applicable NIBR documents with state-of-the-art word processing, electronic publishing and document management systems in collaboration with the responsible author(s).
• Provide advice on template requirements of NIBR submission documents, to effectively guide the authors on document content.
• Work with external consultants (vendors) to coordinate outsourced QC activities related to the processed tasks. Responsible for verifying and consolidating the QC recommendations from the external consultants and partner with the respective document author(s) to reconcile findings and finalize the submission document(s).
• Resolve technical document or workflow issues as applicable on the documents being processed.
• Perform document redaction to remove personal and proprietary information from public facing documents and coordinate the necessary approvals.
• Advise authors, newcomers and vendors on SDV requirements, technical formatting processes and the use of Novartis’ document management systems.
• Generate ideas on areas for optimization and innovation and assist in process improvement activities related to document quality management and submission management in NIBR.
• Remain abreast of current processes, regulatory guidelines and legal requirements, as relevant.
• Assist in the designing, testing, implementation and maintenance of regulatory document templates as well as process and/or system changes.

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.

What You’ll Bring to the Role:

• Bachelor’s degree, strong preference for scientific discipline
• 3+ years of relevant work experience with electronic document management systems and document review.
• 3+ years of experience with and ability to understand compliance practices which include GxPs and Standard Operating Procedures.
• Fundamental understanding of clinical and nonclinical information contained in a submission dossier.
• Demonstrated ability to work successfully within a matrix environment and influence cross functional teams.
• Flexible and detail-oriented approach to documentation management, as appropriate.

Why consider Novartis?
236! million lives were touched by Novartis medicines in 2022, 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?

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.

Accessibility and reasonable accommodation
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877) 395-2339 and let us know that nature of your request and your contact information. Please include the job requisition number in your message

The pay range for this position at commencement of employment is expected to be between $112,000 - $169,000 per year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Novartis is an equal opportunities employer and welcome applications from all suitably qualified persons.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Novartis Institutes for BioMedical Research

Translational Medicine

USA

East Hanover, NJ

Novartis Pharmaceuticals

Research & Development

Full Time

Regular

No

No