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TEMP - Manager, Medical Study Operations (Oncology)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Sleepy Hollow, New York
Start date
Jul 1, 2022

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Job Details

As a Temp Manager, Medical Operations Portfolio & Systems you will be responsible for finance, safety and metrics reporting supporting our Investigator-Initiated (IIS) Studies Program, Research Collaborations and Compassionate Use Programs. Systems support is an additional responsibility of this function and includes both ensuring timely/accurate data collection and entry, as well as systems and report building. 

This position will support our Oncology portfolio

A typical day of a Manager- Medical Operations may include the following: 
•    Financial reporting responsibility across our multiple projects/program(s): IIS, Pre-Clinical Collaborations, Sample Analysis Studies, Collaboration studies, Compassionate Use and Data Transparency
•    Facilitates monthly/quarterly reconciliation meetings with Medical Study Operations product teams ensuring expectations are clearly communicated for meeting prerequisites, and intention and goals of each meeting. 
•    Maintenance of portfolio and program budget trackers for each molecule/activity. Ensure all communicated actuals and accruals are captured, projections are re-forecasted as necessary, and brand give back are fully assessed. 
•    Receiving annual drug projections (COGs), as well as planned spend for packaging labeling and shipments. Maintain financial tracking of drug-related costs and assist with future annualized planning. 
•    Responsible for ongoing analyses, tracking and reporting of projects/programs support, timelines for completion, expected or assessed delays, solutions for streamlining processes for greater efficiency, and other related metrics in support of program activities.
•    Review and approve contracted milestone payments, and ensure study projections are aligned per contract. 
•    Supports the Medical Operations team to track vendor financial payments as needed or required.
•    Ensures appropriate archiving of projects/programs specific FMV benchmarking tools, FMV analysis for each study, and any supporting documentation for justification of fees.
•    Applies appropriate systems used for cross-functional communication, planning and visibility, including but not limited to:
•    Adheres to all relevant processes, trainings, and SOPS to ensure consistency, efficiency, and compliance. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Continued process improvements to ensure consistency, efficiency, and compliance.

This may be for you if
•    You want to make a difference in the lives of patients
•    You demonstrated experience in clinical trials. 
•    You enjoy working rapid-response environment

To be considered for this a Bachelor’s Degree is required. An advanced degree is a plus. 
Your experience will include 5 + years working in area(s) of research and/or regulatory and/or a field-based function in pharmaceutical and/or biotech industry. Active working experience and/or courses pertaining to clinical research and/or Medical Affairs areas such as GCP, Investigator Initiated Studies; medical/educational grants administration; medical information; registries; OIG/PhRMA guidance.A science background and experience in inflammation/immunology/antibody research would be preferred. 

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.

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Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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