Sr Manager GPS Planning

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

The Sr. Manager GPS Planning is responsible for taking a lead role in providing GPS Planning support for studies and to other functions and within GPS. They demonstrate in-depth understanding of applicable regulations and ability to execute effectively across functions and organizations.

In this role, a typical day might include the following:
• Manages planning activities to set up the appropriate process for GPS case management by providing project management support and liaise with the necessary internal and external groups/functions.
• During study start-up, works with study CRO and GPS Case Management to draft and finalize study-specific Safety Management Plan. This includes details on global safety reporting delegated to study CRO and/or license partner.
• Collaborates with GPS Case Management to provide input to study design and conduct that will impact GPS (e.g., EDC design for reporting AESI).
• Conducts ongoing review of study CRO and/or License Partner metrics for safety submissions done on behalf of Regeneron.
• We expect you to escalate issues with study CROs when necessary to ensure timely resolution.
• Liaises with GPS Case Management to set up study-specific conventions for case processing, queries, site training, etc.
• Identifies and leads process improvement activities.
• Authors new and updates to SOPs and Working Instructions.

This role might be for you if:

We seek candidates with a Bachelor's Degree in pharmacy, nursing or degree in healthcare and/or life sciences required, advanced degree preferred.
8+ years' experience

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Requirements:

Education
• Bachelor's Degree
• Pharmacy, nursing or degree in healthcare and/or life sciences required, advanced degree preferred.

Experience
• 8+ years' experience

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.