Sr Mgr PV Planning

Location
Tarrytown, NY
Posted
Oct 03, 2019
Ref
17176BR
Discipline
Administration, General
Required Education
Bachelors Degree
Position Type
Full time
Summary:

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

Responsibilities:

• Manages planning activities to set up the appropriate process for PV 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 PV Case Management to draft and finalize study-specific Safety Management Plan, including details on global safety reporting delegated to study CRO and/or license partner.

• Collaborates with PV Case Management to provide input to study design and conduct that will impact PV (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

• Escalates issues with study CROs when necessary to ensure timely resolution

• Liaises with PV Case Management to set up study-specific conventions for case processing, queries, site training, etc.

• Liaises with other Regeneron functions that require PV support, such as IIS, patient support programs, etc.

• Identifies and leads process improvement activities whether internal or external to PV or Regeneron, including vendors or License Partners.

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

• Effectively manages workload to ensure overall compliance with PV standards

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

• May act as PV SME for both internal and external projects to support both development and commercial projects

• Leads continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to all PV Planning deliverables whether internal or external to the department.

• When applicable, responsible for management of assigned personnel, which includes but is not limited to management of job performance, career development and training.

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.

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.