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Role Description

This role involves owning the full lifecycle of a sample distribution program, ensuring that all phases from design through delivery are executed on schedule and in compliance with regulatory requirements.

• Develop and maintain SOPs and PDMA compliance documentation
• Coordinate the technical implementation of sample-tracking tools in the CRM system
• Train the field sales team on proper sampling procedures
• Act as the primary liaison between the client and salesforce, presenting project updates and reports

This is a remote, contractual position, that goes until the end of September 2026, with the likelihood of extension. Candidates applying for this role must be located in the EST or CST time zones of the USA.

Key Responsibilities

• Oversee the entire physician sampling initiative from defining processes and launching new sample offerings to ongoing distribution and reconciliation
• Manage logistics and inventory, tracking sample usage, and closing the loop on returned or expired samples
• Coordinate between clinical operations, medical affairs, and commercial teams to ensure alignment with clinical guidelines and product lifecycle strategies
• Collaborate with clinical data management and medical affairs teams to capture and document clinical data related to physician sampling programs
• Support audit readiness by ensuring documentation and sampling processes meet clinical trial support standards
• Contribute to clinical process improvement initiatives, ensuring digital tools and operational processes support commercial sampling activities
• Draft, update, and enforce SOPs and compliance materials for all sampling activities
• Work closely with IT and technical teams to implement or upgrade the CRM’s sample-tracking module
• Design and deliver training programs for the sales field team on sampling SOPs and PDMA compliance
• Serve as the main point of contact for client teams and physician offices
• Track program performance and prepare regular reports on sample distribution, inventory levels, and compliance KPIs

Qualifications

• 4-5 years’ experience managing pharmaceutical or sales support programs
• Demonstrated ability to run a full sample program “from end to end”, including inventory management and sample accounting
• Solid knowledge of FDA/PDMA regulations for drug samples
• Proven skill in writing and maintaining SOPs and compliance documents for projects
• Hands-on experience with CRM platforms (e.g. Salesforce, Veeva)
• Ability to coordinate with IT and vendors on system configuration and data integration
• Background in pharma or biotech environments, especially commercial operations
• Experience working in pharmaceutical, biotech, or clinical research environments
• Understanding of clinical governance frameworks such as GxP (GCP, GVP, or GMP)
• Experience collaborating with clinical stakeholders, regulatory teams, or medical affairs
• Familiarity with clinical documentation standards, audit preparation, and healthcare regulatory oversight

Preferred Qualifications

• Experience with sample distribution software or electronic sample closets
• MBA or advanced degree in life sciences/pharmacy; PMP or Six Sigma/Lean certification
• Exposure to clinical systems integration
• Experience supporting clinical-commercial hybrid programs
• Background working in regulated healthcare environments