Manager, Medical Study Operations

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Job description

As a Manager, Medical Study Operations you will be responsible for all operational aspects of multiple projects/programs such as the Compassionate Use Programs, Investigator-Initiated (IIS) Studies Program, Collaboration Studies.

This is an on-site position will require you to be on-site 3+ days/week at our Sleepy Hollow, NY location. We cannot offer a fully remote option. If eligible, we can offer relocation benefits.

A typical day may include the following:

Operational responsibility across programs within Compassionate Use, Expanded Access Programs, IIS, Pre-Clinical Collaborations, Sample Analysis Studies, Collaboration studies, Data Transparency
Participating in team review meetings, product team alignment meetings, and program budget & status update meetings as needed.
Accountable for financial forecasting accuracy of studies within span of responsibility.
Maintenance of program budget trackers, ensuring communicated actuals and accruals are captured, projections are re-forecasted as necessary, and brand give back are fully assessed.
Maintains financial forecast for programs for quarterly for reporting to Accounting & Finance, and responsible for ensuring issue resolution for all discrepancies.
Managing drug supply for Compassionate Use and IIS programs, as appropriate.
Ongoing analyses, tracking and reporting of projects/programs support, timelines for completion, expected or assessed delays.
Participating in solutions for streamlining processes for greater efficiency, and other related metrics in support of program activities.
Manages vendors and financial tracking as required per program.
Ensuring appropriate archiving of projects/programs essential documents.
Uses appropriate systems to contribute to cross-functional communication, planning and transparency.
Ensuring ongoing QC of SharePoint document storage for completeness and audit readiness.
Utilization of QlikSense, QlikView, SharePoint, Oracle and ERRS portal to support team needs.
Adheres to all relevant processes, trainings, and SOPS to ensure consistency, efficiency, and compliance.
Continued process improvements ensuring consistency, efficiency, and compliance.

This may be for you if you:
Want to have an impact on patient lives.
Can work effectively in a rapid-response environment.
Enjoy collaborating with different partners (clinical, pre-clinical, commercial, external customers)
Want to make a difference in developing processes and systems.

To be considered a bachelors degree is required and an advanced degree preferred. You are to have 5+ years experience working in clinical research or medical operations within the pharmaceutical or biotech industry. Active working experience and/or courses pertaining to clinical research and/or MA areas (such as GCP, Investigator Initiated Studies; medical/educational grants administration; medical information; registries; OIG/PhRMA guidance.).

Preferred experiences:
Compassionate Use or Managed Access programs
A science background with active experience in the areas of inflammation/immunology/antibody research.
Working within or supporting Medical Affairs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$110,900.00 - $181,100.00

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