Serialization Project Leader Full Time NEW

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.

Job Description

About the Role

As a Serialization Associate, you will serve as a front-line execution specialist responsible for investigating, resolving, and documenting DSCSA compliance exceptions across our pharmaceutical 3PL client portfolio. Working in a fast-paced, 24×6 support environment, you will own ticket resolution from triage to closure — ensuring serialization events are accurate, compliant, and fully traceable.

What You’ll Do

▸ DSCSA Transaction & Exception Handling

• Investigate and resolve EPCIS file failures including schema errors, master data mismatches, and event sequence violations
• Validate commission events, aggregation hierarchies (SSCC to Case to Each), shipping/receiving confirmations, and returns verification events
• Review inbound and outbound EPCIS transactions for accuracy prior to retransmission
• Identify and correct mismatches in SGTIN/SSCC, GLN/SGLN, lot/expiry data, and business step inconsistencies
• Document all exceptions and resolutions in ServiceNow with sufficient detail for audit purposes

▸ Serialization Lifecycle Execution

• Apply working knowledge of the full DSCSA event lifecycle: Commission, Pack/Aggregate, Ship, Receive, Return, and Destroy
• Validate aggregation integrity before authorizing outbound shipment events
• Troubleshoot serialized returns and product status discrepancies across trading partners
• Support reprocessing and retrigger strategies for failed or rejected events

▸ Platform & Repository Troubleshooting (L4 Systems)

• Work within serialization platforms including TraceLink, rfxcel, and Systech
• Identify and resolve common repository rejections: duplicate commissioning, invalid aggregation structures, missing transaction identifiers
• Collaborate with senior team members on complex platform-level issues requiring configuration review

▸ Regulatory Compliance Awareness

• Maintain working knowledge of DSCSA Section 582 requirements, product tracing/verification obligations, and serialized returns saleable verification workflows
• Understand suspect/illegitimate product investigation triggers and escalation protocols
• Ensure all activities align with GS1 standards and DSCSA regulatory requirements

▸ Operational Excellence & Ticket Management

• Respond to assigned tickets within defined SLAs — no silent aging
• Maintain full incident ownership through resolution with structured handoff documentation
• Escalate systemic trends, recurring failure patterns, or compliance-at-risk items to the Project Leader
• Participate in shift handoffs with concise, structured status communication

Qualifications

What We’re Looking For

▸ Required Qualifications

• 5+ years of experience in pharmaceutical serialization, DSCSA operations, or supply chain compliance
• Hands-on experience with EPCIS file formats and GS1 standards (SGTIN, SSCC, GLN, BizStep)
• Familiarity with serialization platforms such as TraceLink, rfxcel, Systech, or SAP ATTP
• Experience in ITSM environments — ServiceNow preferred
• Strong analytical skills with close attention to regulatory detail
• Effective written communication for cross-functional audiences
• Ability to work on US Central Time shift

▸ Preferred Qualifications

• Experience supporting a pharmaceutical 3PL or wholesaler (McKesson, AmerisourceBergen, Cardinal) in a serialization capacity
• Exposure to WMS platforms (SAP WM/EWM or similar) and their interaction with serialization systems
• Understanding of DSCSA Section 582(d) 3PL-specific obligations
• GS1 Healthcare or DSCSA-related certification
• ITIL-based service management experience

Additional Information

OUR CULTURAL BELIEFS:

Patient Minded I act with the patient’s best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and empower others to act now.

Grow Talent I own my development and invest in the development of others. 

Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

Communication Matters I speak up to create transparent, thoughtful and timely dialogue.

Embrace Diversity I create an environment of awareness and respect.

Always Innovate I am bold and creative in everything I do.

Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.

From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone’s responsibility.

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