Manager, REMS Center of Excellence

Job Description Summary

Join us as a Founder of our ‘new’ Sandoz!

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

 

Job Description

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates.

This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Major Accountabilities:

As the Manager, REMS Center of Excellence, you will work collaboratively with internal and external stakeholders to manage Risk Evaluation and Mitigation Strategies (REMS) in the Sandoz generic and biosimilar portfolios.  And you will serve as the Sandoz safety REMS expert on project/product teams throughout the product life cycle and contribute 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.

Your additional responsibilities include, but not limited to:

• Provide oversight of the tactical implementation and monitoring of REMS commitments including ensuring timely submission of reporting requirements to the FDA.
• Work closely with internal business units, including but not limited to Regulatory Affairs, Medical Affairs, Legal, and Pharmacovigilance in the development and management of REMS programs. 
• Monitor and report progress of REMS/product launches and operations locally and globally, identify risks and mitigations, highlight and resolve issues, and consult with management for input/approval when appropriate.
• Drive execution of REMS development, implementation, and operationalization according to agreed upon strategies.
• Participate and/or lead the evaluation and selection of preferred external consultants/vendors to meet business needs.
• Develop and manage vendor contracts with the support of project teams. Ensure REMS vendors maintain compliance with Sandoz policies with support of Quality team.
• Manage REMS budgets and purchase orders, review and approve vendor invoices, and review and approve program deliverables.
• Ensure compliance with REMS regulatory requirements and reporting, and coordinate REMS training across the organization.
• Establishes policies appropriate for the function and interpret and recommend modifications to companywide policies and practices.
• Manage 1 – 3 REMS programs based on complexity.

Key Performance Indicators 

• Number of programs and activities executed appropriately
• Budget managed within allocated spend
• Program metrics
• Compliance adherence
• Communication and collaboration with internal/external colleagues

Education (minimum/desirable): PharmD, RN, PhD, MS, MPH, MBA, or BS with considerable experience

Experience:

• Minimum of 2 years supporting REMS programs
• Minimum of 5 years in pharmaceutical industry

Position Location:  

This position can be based remotely in the U.S. (but there may be some restrictions based on legal entity).  Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require minimal travel, as business needs require.

Sandoz offers a generous employee benefits package that includes a competitive salary, health insurance coverage for medical, prescription drugs, dental and vision, a generous company match for retirement savings accounts, and generous paid time off.  We also follow a hybrid work policy that combines a mix of in-person and remote work to allow our employees flexibility in designing a schedule that works for our associates and the business. 

The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200/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 be