Sample Accountability Specialist

Location
Sleepy Hollow, New York
Posted
Mar 20, 2018
Ref
12036BR
Required Education
Associate Degree
Position Type
Full time
Position Summary

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, Sample Accountability role ensures that the Regeneron Sample Program is run in a manner compliant with external PDMA and state regulations and with internal Compliance and Sampling SOPs.
This individual in this role will provide day-to-day support for the Sample Program, managing communications to and from field-based personnel and working closely with third party vendors to effectively manage day-to-day operations pertaining to sample accountability.

Responsibilties
• Serve as a point of contact for matters relating to sample accountability aspects of the Regeneron Sample Program for field-based employees, commercial management, and third-party vendors.
• Respond to calls and emails in a timely manner; proactively follow up on open items and provide detailed information as needed to ensure that all inquiries are handled effectively.
• Manage the Acknowledgment of Content Form error mitigation process and propose changes to management as the Program matures, proactively streamlining and enhancing processes in an effort to increase timeliness and accuracy.
• Perform quality checks of Sample Program Forms against third party data as required and proactively manage any necessary remediation
• Work with Field-based personnel and pertinent business partners to resolve any potential compliance issues, for example, potentially negative Signature Verification Letters and Acknowledgment of Content Forms providing appropriate guidance and follow up.
• Work with relevant internal groups to develop meaningful metrics and reports surrounding the Program and then ensure all approved reports are delivered accurately and on time, every time
• Analyze results to identify patterns and exceptions, present to management, and make recommendations for change as appropriate.
• Create and maintain work instructions covering accountability aspects of the Regeneron Sample Program.
• Regularly review and audit the Regeneron Sample Program to ensure third party vendors are consistently adhering to business rules and are in compliance with all company policies and procedures and government regulations.
• Help to enforce the Regeneron sampling policies with Field-based associates.
• Conduct the sample accountability portion of the field personnel new hire training.
• Continuously monitor productivity and make suggestions for changes/improvements to existing processes and initiate new procedures that may increase efficiency.
• Collaborate with the Compliance and Training Departments to ensure Field-based personnel receive initial new hire and annual PDMA training on schedule.
• Work closely with other internal departments to ensure that any changes in the Sample Program are made in alignment with other policies, procedures and system maintenance agreements.

Requirements
• Ability to work independently and in a team environment to accomplish tasks in a timely manner
• Proven experience working in customer-oriented, fast-paced environment
• Ability to maintain professionalism under stressful or adverse conditions
• Strong verbal and written communication skills
• Detail-orientated with strong problem-solving skills
• Ability to handle multiple tasks and work with tight deadlines
• Strong Microsoft Outlook, Word and Excel skills are required
• A general understanding of the PDMA with general knowledge of cGMP and other regulatory requirements
• Bachelor's degree Preferred
• 2+ years industry/relevant professional experience

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.

Requisition Number: 12036BR