347122BR
Jun 14, 2022
USA

Job Description

Novartis protects 750 million patients and more than 100,000 employees in over 140 countries.

Job Purpose
An individual contributor in the GDD Operations Regulatory Systems and Strategy group responsible for the development, implementation and support of Regulatory systems for the Novartis global product portfolio.

Major Accountabilities
• Act as system owner deputy for Vital/GXP applications. Provide first line systems and end user support e.g. incident management and service request management (including assessing, resolving or escalating technical issues).
• Liaise with GDD colleagues on matters regarding changing regulatory requirements and the related business processes, to ensure proper knowledge transfer to IT business partners for system enhancement requests.
• Prepare documentation such as User Requirement Specifications, Functional Specifications, administrative procedures and Working Instructions to support system implementations.
• Participate as key business contributor for Technology initiatives including but not limited to Systems upgrades, Validation, implementation activities and functionality enhancements.
• Support user training for RA end users and IT partner as required. Mentor junior level associates.
• Oversee and support PQ testing and Application verification activities. Develop, implement, and support innovative regulatory strategies and life-cycle management of RA systems.
• Manage global projects and initiatives related to Regulatory applications and business processes with minimal supervision. Contribute to external partnership, Divestments, M&A initiatives by assessing the technical capabilities of potential new external partners.
• Provides recommendations on the approach for the application of expert knowledge of global regulatory requirements for systems with all contributing stakeholders to ensure compliance.
• Identifies and investigates operational needs, problems, and opportunities, contributing to the implementation of improvements within area of responsibility.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

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

Education
• BS or MS degree in a relevant discipline required. Master’s degree preferred.

Experience
• Minimum of 7 years+ systems related experience in Pharma (preferably in a Regulatory Operations Environment).
• Strong and effective interpersonal and leadership skills, with an ability to liaise with individuals at all levels within the organization. Demonstrated team player, collaborative and willing to learn. Ability to perform under time pressure, to plan and prioritize workload; highly motivated and flexible.
• Knowledge of the worldwide Health Authority submission formats as well as the overall drug development process and related document requirements is desirable.
• Knowledge and experience with eCTD, IDMP, Publishing Standards and applicable related tools is desirable. In-depth, knowledge of ticketing tools, validation tools and concepts of Software Development and testing is desirable.
• Strong project management and time management skills to manage multiple, complex projects simultaneously. Ability to work independently and with minimal supervision and lead as needed.
• Demonstrates a Quality, Compliance and Innovative mindset. Proficiency with RA relevant computer programs and systems with demonstrated ability to learn and train others on new systems quickly. Strong analytical and problem-solving skills and ability to coordinate and work effectively with cross-functional teams.

Languages
• Fluency in English required; oral and written communications skills.

This is an East Hanover, NJ based role. Consideration may be given for distance working arrangements in the US (There may be exceptions based on US Legal Entity registration).

Why Novartis?

766million 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!
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Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusion workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
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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
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Accessibility and reasonable accommodations:

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 [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.
Global Drug Development
REG AFFAIRS GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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347122BR

RA Systems and Strategy Manager

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