Assoc. Dir./Dir., Sample Operations & Accountability

Location
Sleepy Hollow, New York
Posted
Mar 20, 2018
Ref
12035BR
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 Associate Director / Director of Sample Operations and Accountability will oversee the Sample Operations and Sample Accountability teams within Commercial Operations. This individual will be responsible for leading the strategy and continued development of a comprehensive sample program (1) complying with the Prescription Drug Marketing Act (PDMA) and state regulations, and (2) effectively meeting the commercial business needs.

Responsibilities
• Partner with key stakeholders (Legal, Compliance, Regulatory, and Commercial) to set the strategic direction for all direct-to-physician sample by mail programs, ensuring compliance and operational effectiveness.
• Partner with key stakeholders (Brand Owners and Commercial Business Units) to set the strategic direction for all direct-to-physician sample by mail programs, ensuring execution aligned to business needs.
• Identify solutions that support and enhance the capability to track operational efficiencies and effectiveness of programs; drive business process improvements to ensure company's ability to monitor and track sampling activities; analyze trends and lead team to remediate program gaps and issues.
• Oversee the development of written plans, audits outcomes of operational business functions, and implementation of corrective measures where necessary.
• Partner with company Senior Leadership to influence decisions and effect implementation of regulatory strategies in alignment with organization goals.
• Direct the performance of key vendors (compliance, data, fulfillment, validation) and internal systems and processes to ensure the quality of deliverables, adherence to both internal and external standards, and to streamline day-to-day operations.
• Oversee the development and execution of PDMA compliance training programs and materials related to the sample programs; monitor, track and analyze the training process for effectiveness and adherence to program business rules to eliminate company exposure.
• Develop and enforce the maintenance of quality control processes and measures that ensure the accuracy of all report information and data extracts.
• Develop and maintain sampling related company policy documents, and operational sample program work instructions and procedures to ensure compliance with corporate procedures.
• Lead alignment efforts with internal departments to develop, implement, and maintain effective processes and documentation.
• Oversee the Sample Accountability and Operations teams, key vendors (compliance, data, fulfillment, validation), and internal systems and processes in the preparation of new sample programs for launch products.
• Conduct routine internal reviews and audits of vendor activities to ensure ongoing satisfaction based on audit findings and recommend corrective action to ensure action was met.
• Prepare and recommend program operating budgets for approval; monitor spending for adherence to budget and recommend variances as necessary.
• Develop balanced score cards and Key Performance Indicators (KPIs) to track vendor performance and adherence to statements of work.
• Work with staff to develop objective performance measurements across all sites, to ensure consistent, high-quality evaluation and goal setting for all employees.
• Develop team with respect to capabilities, career paths and self-awareness.

Requirements
• 10+ years of progressive pharmaceutical / biotech industry relevant professional experience; 5+ years of sample accountability / PDMA and sample operational experience, or an equivalent combination of education and experience.
• A comprehensive understanding of PDMA and related state regulations, with general knowledge of cGMP, OIG, FDA and other regulatory requirements.
• Hands-on / direct experience working with sample operations and sample accountability for cold chain direct to rep and direct-to-physician sample mail processes and programs.
• Demonstrated ability to conduct investigations and audits to identify gaps and creative solutions to complex problems and implement quickly and successfully.
• Demonstrated ability to drive change / business process improvement.
• Demonstrated experience with cross functional matrix team leadership where team members come from various organizational functions.
• Demonstrated experience with oversight for external vendors with managing to SLAs and budgets.
• Strong organizational, planning/project management and influencing skills are a must. Extensive experience with managing numerous projects concurrently against stringent deadlines.
• Detail-orientated with excellent problem-solving skills, and a focus on continuous improvement.

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: 12035BR