As a Manager, Medical Operations you will be responsible for all process–related aspects for our Medical Affairs Investigator-Initiated, Research Collaboration, Sample Analysis and Data Transparency requests.
A typical day may include the following:
• Ensuring all proposals are complete, aligned with Areas of Interest, are reviewed by the governing body for specific study types. Will ensure all relevant decisions are obtained prior to moving approved studies forward.
• Facilitating Medical Affairs driven meetings & committees, set agendas, drives goals, documents meeting outcomes, and ensures appropriate action items are follow through.
• Responsible for obtaining internal approval of associated study budget, ensuring Fair Market Value analysis on line items has been completed. Will conduct budget arrangements when needed, and initiates the requisition process. Manages ongoing Purchase Order’s (PO) including validation and documentation of achievements completed, invoicing, accruals, projections, yearly trends and annualized budget planning, and reporting to Accounting & Finance.
• 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.
• Analyzing, tracking, and reporting of study progress versus timelines committed by the investigator, data delivery and program impact, and other related metrics in support of program activities.
• Coordinates contracting with Legal, Procurement, and Sites, ensuring contract terms are correct and required documentation of special contractual agreements.
• Managing 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.
• Ensuring collection, tracking, and archiving of all relevant documents, such as IND cross-reference letters, IRB approvals, and renewals, IND acknowledgment letters.
• Ensures timely receipt, tracking and distribution of SAEs, Investigator Alert Letters (IAL), and reconciliations. Periodically runs compliance reports to ensure timelines are within an acceptable range.
• Ensuring internal publications' review, consolidate comments, receipt by Investigator, and documents actions taken.
• Ensures optimal alignment with both Alliance and internal collaborators supporting the project/program, while driving activities forward, and communicating potential risks and solutions transparently.
This may be for you if:
• Want to make a difference in the lives of patients
• Can demonstrated experience in clinical trials.
• Enjoy working rapid-response environment
To be considered you need a minimum of a Bachelors degree preferable in a Science related subject area with over 10 years of proven experience of which 5+ years is in area of clinical research, regulatory or a field-based function. This must be within a pharmaceutical or biotech company along with Medical Study Operations experience. Experience in Immunology and/or antibody research is preferred as is a science based background
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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$121,200.00 - $197,800.00