Temp-Specialist, Medical Operations

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

The Specialist, Medical Operations will assist with tasks and assignments in support of various programs and ongoing projects, such as the various Investigator-Initiated Studies (IIS) Programs, Collaboration Studies, Registries, Compassionate Use Programs, and Phase 4 studies led by Medical Affairs, while ensuring compliance standards are met. Additionally, the incumbent will support MA projects, as requested.

Job Duties:

• Program management activities: Has responsibility supporting specific tasks/assignments with supervision and oversight:
Pharmacovigilance Compliance activities - Investigator Alert Letters (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 Investigators are not included in OIG exclusion list, FDA debarment list, and completing Anti-Bribery-Anti-Corruption (ABAC) requests.

• Systems Management: Learns to use appropriate 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, Oracle and ERRS portal (Polaris)

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

• Note: Due to the varying number of projects that will need to be supported at different times there may be a wide range of time allocated to activities, allowing for unique involvement based on prior work experience and skills of incumbent. For a given year and as part of the Annual Goals planning, the type/scope of projects and weight will be clearly defined.

Requirements:

• Requires minimum BA/BS degree in a related field preferably.

• 4+ years of "progressive" industry/relevant professional experience.

• 2 + years of work experience in area of clinical research and/or regulatory and//or field-based function in pharmaceutical and/or biotech company(ies) and experience or courses pertaining to clinical research and/or MA functional areas

• Works well in fast-paced, dynamic environment, self-motivated, works with limited supervision, once acclimated to role and enjoys working with different stakeholders.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.