Novartis Hiring for Associate Director, US Safety Risk Management (REMS) job in East Hanover Full Time

About the role
Location: Onsite/Hybrid
#LI-Hybrid #LI-Onsite

To work collaboratively with internal and external stakeholders to lead Risk Evaluation and Mitigation Strategies (REMS) in the Novartis portfolio.

Your Key Responsibilities:
• Serves as the Novartis safety REMS expert on project/product teams throughout the product life cycle and contributes to the development and implementation of innovative, evidence-based risk management solutions, including enhanced pharmacovigilance and risk minimization activities that will ensure optimized benefit with minimized risk
• Provides oversight of the tactical implementation and monitoring of REMS commitments including ensuring timely submission of reporting requirements to FDA
• Works closely with Regulatory Affairs, Medical Affairs, and Pharmacovigilance in the development and management of REMS
• Monitor and report progress of program launches and operations, identify risks, highlight issues, seek input/approval from management
• Ensures compliance with REMS regulatory requirements and coordinates REMS training programs across Novartis
• Coordinates the use of external consultants/vendors as appropriate based on business needs to operationalize large scale ETASU REMS programs
• Participate and/or lead the evaluation & selection of vendors according to Novartis procurement policies where applicable
• Develop and manage vendor contracts with the support of project teams
• Manage REMS budgets, review and approve vendor invoices, and review and approve program deliverables
• Establishes policies appropriate for the function
• Interprets and recommends modifications to company-wide policies and practices

Commitment to Diversity & Inclusion:
We 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.

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 let us know the nature of your request, your contact information and the job requisition number in your message:

• Novartis: e-mail [email protected] or call +1 (877)395-2339
• Sandoz: e-mail [email protected] or call: +1-609-422-4098

Role Requirements
• PharmD, RN, PhD, MS, MPH or BS with considerable safety and risk management experience
• 8+ years pharma industry experience and 3-5 years of REMS experience

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: 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.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $158,400 – $237,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.

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