Temp-Senior Manager, Medical Operations

The Senior Manager, Medical Operations will be responsible for our process-related aspects for Medical Affairs. Our projects focus on Investigator-Initiated, Pre-clinical Collaboration, Sample Analysis, Data Transparency and RWE HEOR for multiple products and new molecules. You will ensure our compliance standards are achieved.

A typical day may include:

Program management activities:

• Proposal Management: Ensures all proposals are complete, aligned with Areas of Interest, are reviewed by the governing body for specific study types, and all relevant decisions are obtained prior to a moving approved studies forward.
• Meetings & Committees: Facilitates Medical Affairs driven meetings & committees, sets agenda, drives goals, documents meeting outcomes, and ensures follow-up for any action items determined.
• Budget Management: Responsible for obtaining internal approval of associated study budget, ensuring Fair Market Value analysis on line items has been completed.
• Drug Supply: Proactive drug campaign planning for various programs in advance of study initiation, including any specific packaging and labeling requirements needed for individual studies/programs, country specific requirements, and ensuring Import Licenses are obtained and QPV release occurs when necessary.
• Metrics & Reporting: Responsible for ongoing analyses, tracking and reporting of study progress versus timelines committed by investigator, data delivery and program impact, and other related metrics supporting program activities.
• Contracting: Coordinating contracting with Legal, Procurement, and Sites, ensuring contract terms are correct and which may require special contractual agreements.
• Vendor Management: Manage vendors from RFP and vendor selection thru contracting and study implementation. Ensure study deliverables from the vendor(s) are met as outlined in the SOW.
• Essential Documents: Ensures collection, tracking and archiving of all relevant documents, such as IND cross-reference letters, IRB approvals and renewals, IND acknowledgment letters.
• Pharmacovigilance Compliance: Ensures timely receipt, tracking and distribution of SAEs, Investigator Alert Letters (IAL), and reconciliations. Periodically runs compliance reports to ensure timelines.
• Publications: Ensures internal publications review, consolidates comments, receipt by Investigator, and documents actions taken.
• Antibody/Samples: For studies utilizing antibodies in a Pre-Clinical model, collecting PK, ADA, or genetics samples, or for studies providing clinical samples, ensures timely shipments, reconciliations, analysis and data delivery when appropriate
• Systems Management: Utilizes appropriate systems to facilitate cross-functional communication and planning.
• Process: Adheres to all relevant processes, trainings, and SOPS to ensure consistency, efficiency, and compliance.
• Alliance Management: Ensures optimal alignment with both Alliance and internal partners in support of project/program, while driving activities forward, and communicating potential risks and solutions.

This may be for you if:

• You are passionate about the impact your work can have on the healthcare community
• You enjoy a work environment with cross-functional teams.
• You are at ease with an abundance of detail and complexity, yet mindful of the big picture.
• You have the innate ability to balance multiple projects and initiatives, prioritize them and execute them independently, while excelling at keeping all partners advised and engaged

To be considered for this you need minimum BA/BS degree in a related field preferably. Your experience should include 10+ years of industry/relevant professional experience. At least 5 years active work experience in area of clinical research, regulatory or field-based functions in pharmaceutical or biotech and experience or courses pertaining to clinical research and/or MA functional areas. Additionally, any experience in ophthalmology or antibody research would be helpful.

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.