Senior Specialist, Medical Operations, Medical Affairs

Location
Tarrytown, NY, United States
Posted
Nov 06, 2020
Ref
22174BR
Required Education
Bachelors Degree
Position Type
Full time
As a Sr. Specialist, Medical Operations you will support various programs and ongoing projects, such as the Investigator-Initiated Studies Programs, Collaboration Studies, Registries and Compassionate Use Programs led by our Medical Affairs team.

A typical day may include
Program management activities-Has responsibility supporting specific tasks/assignments with supervision and oversight:
  • Pharmacovigilance Compliance- Distribution and appropriate tracking of receipt and delivery, and/or Serious Adverse Events 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 - Ensuring all appropriate documentation in support of a proposal has been collected and filed accurately within the document repository systems on an ongoing basis.
  • Due Diligence process - Verifying Principal Investigators are not included in OIG exclusion list, FDA debarment list, and completing ABAC requests.

Systems Management: Learns to use appropriate systems which contribute to cross-functional communication, planning and transparency, including but not limited to:
  • Report generation: 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 a great teammate and work efficiently within a fast-paced, collaborative environment
  • You have effective communication and presentations skills (verbal and written)
  • You are self-motivated and can work with minimal supervision
  • Have excellent judgment in elevating issues to the appropriate team members for consideration and resolution

To be considered for this, you should have a minimum BA/BS degree in a related field with 6+ years of biopharma industry professional experience. You should also work well in fast-paced, dynamic environment, self-motivated, works with limited supervision, once acclimated to role and enjoys working with different stakeholders.

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.