PDMA Sample Compliance Coordinator  Job Listing at Kelly Services in Bridgewater, NJ (Job ID US3582741_BH9893627)

Description

Job Title:  PDMA Sample Compliance Coordinator 
Location:  Fully Remote  MUST reside in Eastern Time Zone
Type of Position:  Full Time with possibility of hire after 6 months
Schedule:  Must be available to work 8:00am - 5:00pm Eastern Time Zone/Monday - Friday
Pay:  $37.85 - $45.82 based on experience 
Start Date:  ASAP

The PDMA Sample Compliance Coordinator  is responsible for oversight and management of our drug sampling programs and business requirements related to these programs.  This role involves proactive monitoring of sample distribution data, field training, and driving continuous improvement initiatives across sample accountability processes by developing and maintaining standard operating procedures, overseeing third-party vendor relationships, and ensuring adherence to regulatory requirements such as FDA reporting.  Through strong cross-functional collaboration and attention to detail, this individual supports operational excellence and compliance in all aspects of sample operations. Responsibilities and Duties: Documentation & Compliance

• Define and maintain departmental Work Instructions and Standard Operating Procedures (SOPs).
• Ensure all sample data adjustments comply with Good Documentation Practices (GDP) and established SOPs.
• Review, update, and maintain training materials to ensure alignment with current processes and procedures.
• Monitor all aspects of FDA reporting requirements and ensure timely and accurate submissions.
• Support the oversight of the Sample Monitoring Program, including the adherence of non-conformance guidelines.

Vendor & Stakeholder Management Support

• Establish and maintain business rules between the company and third-party vendors.
• Proactively review and optimize business rules and processes related to sample distribution and accountability.
• Support the management of third-party vendors to ensure adherence to business rules and service level agreements (SLAs).
• Help facilitate ongoing communication with vendors and internal stakeholders through meetings, emails, and formal notifications to identify issues, determine root causes, and implement corrective actions.
• Participate in Quarterly Business Review (QBR) meetings with third-party vendors and provide actionable feedback.

Sample Program Oversight

• Monitor and verify that all drug transactions are accurately documented and accounted for.
• Ensure compliance with Prescription Drug Marketing Act (PDMA) requirements, including training and recertification.
• Confirm that all field personnel are properly trained before being granted sample eligibility.
• Verify timely sample closeouts for field representatives leaving the sample program.
• Monitor sample distribution data and escalate issues or recommend improvements as needed.
• Assist with third-party vendor sample destruction in accordance with regulatory and company guidelines.

  Experience and Education

• High School Diploma required.
• Bachelors degree required. 
• 1 year of experience with Prescription Drug Marketing Act -  PDMA requirements, including training and recertification.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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