Sr. Manager, PV Case Management

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.

Summary:

The Senior Manager Case Management is responsible for proactively managing routine Vendor Management and Case Processing deliverables and activities in accordance with applicable regulations and agreements.

Job Duties:

• Serves as a primary point of contact with vendor for managing routine activities and addressing related issues

• Evaluates all adverse event reports received from the case processing vendor for accuracy and regulatory reporting. Monitors case finalization work stream and prepares reports for distribution.

• Identifies and leads process improvement activities whether internal to group or PVRM; or involving groups external to PVRM or Regeneron, including vendors or License Partners.

• Works effectively with external departments and License Partners on relevant PV deliverables (ex. works with Medical Affairs on post-marketing studies/programs).

• Exercises independent judgment in managing case processing PV deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables.

• May be responsible for management of assigned personnel.

• Effectively manages workload to ensure overall compliance with PVRM standards

• Takes initiative in the ongoing process improvement for quality and compliance

• Authors new and updates to SOPs and Working Instructions, and conduct related training.

• Responsible for management of assigned personnel.

• Manage and develop staff, including quality standards, adequacy of training, job performance/ contributions, work quality and career development.

Requirements:

Education

• Bachelor's Degree in life sciences required

• Pharmacy, nursing or equivalent 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.