Director / Associate Director, Sample Operations – Regeneron – Tarrytown, NY, USA
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
The Associate Director of Sample Operations will oversee the development and implementation of a comprehensive sample programs complying with the Prescription Drug Marketing Act (PDMA). This will include the development of a written plans, regular audits of operational business functions, and implementation of corrective measures where necessary. Candidate shall engage and partner with Senior Leadership to influence decisions and effect implementation of regulatory strategies and considerations in alignment with organization goals.
- Work with key stakeholders to lead the development of new and existing sample programs building a framework for strategic direction and oversight of all direct-to-physician mail programs, ensuring compliance and operational effectiveness.
- Identify solutions that support and enhance the capability to track operational efficiencies and effectiveness of programs; develop and implement new and re-engineered business processes to ensure company’s ability to monitor and track activities; analyze trends and lead team to remediate program gaps and issues.
- Proactively manage the performance of critical vendors and internal processes to ensure the quality of deliverables, adherence to both internal and external standards and to streamline day-to-day operations and increase efficiency.
- Develop PDMA compliance training programs and materials as it relates to sample operations. Additionally, monitor, track and analyze the training process for effectiveness and adherence to program business rules to eliminate company exposure.
- Develop and maintain stringent quality control process and measures that ensures the accuracy of all report information and data extracts.
- Lead alignment efforts with internal departments to develop, implement, and maintain effective processes and documentation.
- Conduct routine internal reviews and audits of vendor activities to assure ongoing satisfactory. Based on audit findings, recommend corrective action and ensure action was met.
- Prepare and recommends program operating budgets for approval. Monitors spending for adherence to budget and recommends variances as necessary.
- Develop balanced score cards and objective Key Performance Indicators to track vendor performance and adherence to statements of work.
- Oversee the development and implementation of standardized sample program work instructions and procedures to ensure compliance with corporate procedures.
- Work with staff to develop objective performance measurements across all sites, to ensure consistent, high-quality evaluation and goal setting for all employees.
- Bachelor’s Degree required; or a minimum of ten (10) years of experience and/or relevant training in a business related environment within the pharmaceutical industry; or an equivalent combination of education and experience.
- A comprehensive understanding of PDMA with general knowledge of cGMP, OIG, FDA and other regulatory requirements.
- Hands-on/direct experience working with sample operations, sample compliance and sample accountability working with cold chain direct-to-physician sample mail programs 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 experience with cross functional matrix team leadership where team members come from various organizational functions.
- 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.