Temp- Sr Specialist- Medical Operations

Location
Tarrytown, New York, United States of America
Posted
Jul 04, 2021
Ref
25232BR
Required Education
Bachelors Degree
Position Type
Full time
As a Sr. Specialist, Medical Operations will assist with tasks and assignments for various programs and ongoing projects, such as the various Investigator-Initiated Studies Programs, Collaboration Studies, Registries and Compassionate Use Programs led by Medical Affairs, while ensuring compliance standards are met.
A typical day may include the following:

Program management activities: Responsibility supporting specific tasks/assignments with supervision and oversight of :
  • Pharmacovigilance Compliance activities - IAL distribution and appropriate tracking of receipt and delivery, and/or SAE reconciliations
  • Drug Supply Management - Tracking of drug inventory per product, executing shipments and processes drug related issues, inclusive of temperature excursions, expiry events, quarantines, drug destructions and product complaints
  • Essential Document Maintenance - ensures all appropriate documentation in support of a proposal has been collected and filed correctly within the document repository systems on an ongoing basis.
  • Due Diligence process - may assist with verifying PI's are not included in OIG exclusion list, FDA debarment list, and completing ABAC requests.

Systems Management: Appropriate use of systems which contribute to cross-functional communication, planning and transparency, including but not limited to:
  • Running of reports in preparation for financial and/or study status update meetings, including QlikSense, QlikView, SharePoint, and ERRS portal (Polaris)

Process: Adheres to all relevant processes, trainings, and SOPS to ensure consistency, efficiency, and compliance.

This may be for you if:
  • You are details oriented
  • Have experience in a Medical Operations function with the biopharma industry
  • Enjoy a fast paced environment working on a diverse set of projects.

Education

To be considered for this you are required to have a minimum of a /BS degree in a related field with 6+ years of "progressive" industry/relevant professional experience. Works well in fast-paced, dynamic environment, self-motivated, works with limited supervision, once acclimated to role and enjoys working with different partners.

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.