The Manager, Sample Compliance will be responsible for US Commercial’s compliance with the Prescription Drug Marketing Act (PDMA) and other state and federal sampling requirements.  They will accomplish this through routine monitoring, auditing, and reporting of all sample activity through a variety of channels across the US and Puerto Rico.  This is a highly matrixed role and will work in close partnership with our Enterprise Field Effectiveness, Field Sales, Brand Marketing, GSK Response Center, GSK Tech, and external vendors.  It is expected the right candidate will bring a continuous improvement mindset and familiarity with process automation and data/analytical capabilities.

Key Responsibilities:

• Evolve the monitoring of sample distribution by using data and process automation skills to eliminate waste and implement innovative monitoring strategies / capabilities
• Participate and provide direction for new product launches where sample activity will occur
• Serve as primary point of contact for internal and external government agency audits involving GSK and ViiV samples
• Identify and escalate all issues of sample non-compliance to appropriate parties, including HR, Legal, Sales Management, Ethics & Compliance, and senior management
• Partner with appropriate stakeholders for any potential for-cause sample investigations
• Partner with Sample Operations to maintain a fit-for-purpose control environment with clear and accurate documentation of processes including maintaining the US Commercial policy and procedure on sample activity
• Be the sample subject matter expert and provide timely, accurate and effective communication, resolution, and follow-up of sample compliance questions and/or issues
• Develop and maintain US Commercial sample compliance training materials
• Lead external sample compliance reporting to comply with regulatory timelines
• Maintain regular reporting and dashboards to demonstrate adequacy of key controls
• Identify and remediate vendor-related or internal control gaps impacting sample compliance

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s Degree
• Experience managing sample activity within the life sciences
• Experience leading/influencing delivery across matrix teams
• Experience using data for decision making and influencing strategy
• Process improvements experience using ADP, Six Sigma, and/or Lean principles

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Process automation skills and tools
• Expert knowledge of relevant policies and guidelines, industry regulations and guidelines, PDMA requirements, FDA requirements and other relevant laws
• Six Sigma Certification (Green Belt or higher)
• Proven knowledge of business intelligence tools (PowerBI, Tableau, Qlik)
• Excellent verbal/written communication, listening and interpersonal skills
• Ability to maintain confidentiality and trust around sensitive compliance issues
• Ability to prioritize and the flexibility to adapt to changing priorities.
• Proven initiative, self-motivated and flexible with ability to work independently and deliver results
• Demonstrated high learning agility in a continuously changing environment

#LI-GSK

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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