Responsible for managing all Sample Accountability responsibilities in the U.S. ensuring total compliance with the Prescription Drug and Marketing Act (PDMA). Administers and manages multiple compliance accounts for the field sales sample activities in a pharmaceutical marketing environment. Manages external vendor(s) and supervises all co-sourced activities of assigned Sample Accountability Analysts and Coordinators. Responsible for maintaining pertinent Policies, SOPs, and work-flows current and updated at all times.
Sample Management Program Responsibilities:
o Manage and maintain the overall company sample program and sample-related activities for operational optimization and compliance with applicable laws, regulations, policies and standards. This includes continued assessment and oversight of:
- product sample planning and sample allocations by product in collaboration with Marketing and Sales operations
- sample utilization analysis & reporting
- authorization of any sample transfers where consistent with policy
- sample returns monitoring
- address any sample-related issues reported by internal employees or external customers; review and analyze the documentation reported in the Veeva CRM to verify, or confirm sample program-related information; this includes the review, analysis and reporting of third party-reported data or information (vendor reported), such as loss, theft or diversion of product samples or associated documentation
- oversee and ensure completion of monthly product reconciliations, issue reports and communicate at all levels within the sales department to address and correct any issues identified
- analyze variances and report significant variances to the Compliance officer and the FDA, per policy
- facilitate sales rep close-outs
- monitor and assess sales representative & DTP partner compliance with PDMA requirements and company policy
- Generate monthly sample activity-related reports and send to Finance for month end reporting
- Document & report month end inventories, transfer, samples received
- Conduct monthly analysis of sample utilization and cost effectiveness to assess monthly sample allocation
- Manage monthly sample budget
o Maintain pertinent company policies and SOPs to remain current with applicable requirements at all times
o Develop, deliver and oversee training of all the staff members who have sample-related responsibilities
o Monitor sample program implementation Identify and address sample-related risks or non-compliance, including sample signature verification issues, and escalate, as applicable, with sales management or Compliance, those issues that impact on overall company compliance with applicable laws, regulations and policies. Collaborate with Compliance to implement corrective and preventive actions and actively participate to conduct for-cause-audits related to sample activities.
o Collaborate with Compliance in all the activities related to transparency reporting in compliance with federal, state and local laws and requirements.
· Collaborate with IT to provide solutions that maximize system capabilities (e.g. Veeva), report system issues, identify and recommend system enhancements and work cross functionally to implement or ensure implementation of process improvement.
· Establish and maintain processes and tools for HCP license verification requirements across vendors and/or systems.
· Maintain the designated repository for all required documentation to remain accurate, complete and secured from unauthorized access.
REQUIRED EDUCATION AND EMPLOYMENT QUALIFICATIONS
· BA/BS degree or equivalent experience
· 7+ years of experience in the Pharmaceutical industry
· 4+ years of experience managing Sample operations, Sample accountability, and compliance, with demonstrated PDMA proficiency
· Strong organizational skills and the ability to independently prioritize workload with minimal supervision. Ability to successfully manage multiple, simultaneous responsibilities.
· Excellent verbal and written communication skills
· Ability to use a variety of problem-solving techniques to generate a range of possible solutions, apply and follow through on selected solutions
· Keen attention to detail and adaptability to change
· Ability to communicate and interact at all levels within the company
· Collaborative and hands-on team player
· Proficiency with Sales Force Automation systems and administration (e.g. Veeva)
· Ability to identify trends via data analysis
· Proficient in MS Office (Outlook, PowerPoint, Excel)
· Exceptional time management skills
· Willingness to learn and manage additional important Commercial Operations responsibility (e.g. Fleet Operations, Commercial Meetings & Events, etc.)
· Considerable project management experience
· Ability to analyze and present trend data to senior leadership
· Commercial Operations / Sales Operations experience(s)
· Sales Support experience
We invest heavily in R&D with nearly 14% of sales revenue and employees devoted to achieving our goal of being a leader of innovation in medical dermatology. Almirall strives every day to turn our expertise into real solutions. Through science, research & development, discovery agreements and alliances, we are building solid partnerships driven by the shared goal of discovering medical solutions to improve the lives of patients.