Job Title: DSCSA Serialization Analyst
Location: Remote
Department: Serialization and Compliance
About EVERSANA:
At EVERSANA, we are proud to be recognized as a Great Place to Work globally. We are committed to creating a healthier world through our innovative commercialization services for the life sciences industry. Our team of over 7,000 employees works with more than 650 clients to help bring next-generation therapies to market and support the patients who rely on them. Join us as we make an impact every day in healthcare!
We embrace diversity and inclusion, and we are committed to fostering a culture that celebrates various backgrounds and experiences. Improving patient lives around the world is our priority, and we need passionate individuals from all walks of life to build the future of healthcare and life sciences.
Position Summary:
The DSCSA Serialization Analyst will support the serialization of the pharmaceutical supply chain to ensure compliance with the Drug Supply Chain Security Act (DSCSA). This role involves direct interaction with clients and their customers, assisting with implementations, testing, and support for production integrations. The role is key in ensuring the efficient and effective resolution of supply chain issues, particularly in relation to serialization and regulatory compliance.
Key Responsibilities:
Serialization Support and Integration:
Interface directly with clients and customers to support Serialization integration for DSCSA regulatory compliance.
Assist in the implementation of DSCSA requirements, including EPCIS file formats. Generate and communicate test files and support the transition to production.
Resolve and communicate revised EPCIS files for shipment variances.
Collaborate with the EDI team to support DSCSA electronic documents.
Manage the documentation of serialization projects and day-to-day activities.
Coordinate with vendors and other technology teams to implement serialization projects and resolve open issues.
Technical Skills and Support:
Demonstrate a strong understanding of DSCSA, EPCIS, and XML file-based data exchange.
Experience with serialization solution providers such as Tracelink and Rfxcel is beneficial.
Provide support to clients and customers in implementing serialization solutions and ensuring regulatory compliance.
Diversity, Equity & Inclusion:
Demonstrate a commitment to diversity, equity, and inclusion through continuous development and proactive management of bias.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent experience required.
EDI experience is a must. Preference for those with experience in EPCIS/XML.
Familiarity with AS2, sFTP, and other communication protocols.
Experience with Sterling Integrator is a plus.
Skills and Competencies:
Excellent interpersonal and communication skills to effectively collaborate with clients, customers, and internal teams.
Strong problem-solving and analytical abilities to identify and resolve issues in serialization processes.
Detail-oriented with the ability to handle complex data and documentation tasks.
Additional Information:
All information will be kept confidential according to EEO guidelines.
Diversity, Equity & Inclusion are core values at EVERSANA. We are an Equal Opportunity Employer, and we embrace employees from diverse backgrounds and experiences. We believe that all points of view contribute to our success.
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