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Senior QC Specialist, Submission Management and Quality

Employer
Novartis
Location
East Hanover, New Jersey, United States
Salary
Competitive
Closing date
Feb 13, 2023

View more

Discipline
Other, Manufacturing/QA/QC
Position Type
Full Time
Organization Type
Pharma

Job Details

Job Description

40! The number of Clinical Submission Documents you will review as the new Sr QC Specialist based at Novartis in East Hanover, NJ. As part of Submission Management and Quality team, you will be responsible for conducting the clinical content review and identifying inaccuracies for preclinical and/or clinical documents (e.g. Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, and Clinical Overview) filed by Novartis Pharmaceuticals to governmental Health Authorities.

Your main accountabilities will include but not be limited to:
• Provide independent clinical/scientific review of clinical summary documents (such as SCE, SCS, SCP, SBP and CO) and identify content inaccuracies prior to submission to Health Authorities, e.g.:
o Verify accuracy (100% review) of all factual statements within summary document text compared to post-text sources cited.
o Verify numeric accuracy (100% review) of all data cited throughout text and hand derived in-text tables compared to post-text sources cited.
o Verify appropriateness of all internal/external citations noted within summary document.
• Develop and provide factual evidence to support all discrepant findings for review and approval by Submission Team or document authors.
• Mentor/Train new or junior QC specialists to achieve department goals for excellence in quality review.
• Compile comprehensive documents containing discrepancies identified from QC reviews (with corresponding factual ‘Evidence’) for each clinical summary document in preparation for resolution meeting;
• Provide cross-divisional support through quality review of divisional specific documents such as CSRs
• Contribute/Co-Lead SMQ Quality work streams to streamline and further develop quality
practices cross-divisionally, from defining the problem to designing and implementing solutions

The ideal location for this role is the East Hanover, NJ site, where hybrid working principles apply, but a distant working arrangement may be possible in certain states. US associates living more than 50 miles (one way) away and who reside in a different state from their Novartis office will require a formal DWA to ensure appropriate state tax compliance. Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to East Hanover, NJ site, as determined necessary by hiring manager. US associates living more than 50 miles (one way) away and who reside in the same state as their Novartis office may be eligible for an exception to the hybrid working principles. This position will require less than 5% travel as defined by the business (domestic and or international).

Please note this position will not include relocation support and only local candidates will be considered.

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

What you will bring to the role:
Ideal Background:
Education
(minimum/desirable):
Bachelor’s degree required,
Advanced degree in scientific /health or management discipline preferred to allow for the review of SBP and SCP documents
Languages: Fluent English language capabilities required
Experience/Professional
requirement:
• >5 years’ experience in clinical research with proven proficiency in global clinical development.
• Ability to understand, interpret complex clinical/scientific and statistical data and effectively communicate in clinical summary documents to authors.
• Demonstrated strong medical/scientific communications (written)
• Proven ability to work independently to deliver clinical summary document discrepant findings within defined timelines (e.g. 4 working days).
• Previous experience in clinical development of NDA/MAA deliverables with knowledge in world-wide regulatory requirements for drug registration
• Solid computer technical skills (Word/Excel/PDF development) and ability to learn new systems quickly.

Why Novartis?
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!

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the 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 $102,400 and $153,600/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.
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

Company

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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