DSCSA Analyst

Cosette Pharmaceuticals, Inc.; Bridgewater Township (NJ); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

Short-term disability

Long-term disability

401(k) match

FSA

HSA

EAP

Tuition reimbursement

Parental leave

Wellness program

Paid time off

Volunteer time

Holidays

Job summary

Cosette Pharmaceuticals, Inc. seeks a DSCSA Analyst to support DSCSA compliance across the organization. The role involves analyzing data, building tracking systems, and coordinating with partners to ensure regulatory alignment.

A strong background in pharmaceutical supply chain operations and DSCSA regulations is essential. Responsibilities include data analysis, data validation for serialization, traceability, and verification, and collaboration with cross-functional teams to move DSCSA files

Qualifications

• Bachelor's degree required in IT, Supply Chain or related field.
• Minimum 4 years of experience in pharmaceutical or healthcare industry with DSCSA compliance.
• Strong understanding of DSCSA and regulatory requirements.

Responsibilities

• Analyze supply chain data to ensure DSCSA compliance.
• Collaborate with cross functional teams on serialization, traceability and verification data.
• Support DSCSA implementation with EPICS data files and production readiness.
• Interface with EDI team to support DSCSA electronic documents.
• Troubleshoot data discrepancies and system integrations to maintain compliant operations.
• Develop and maintain documentation and reporting to track compliance metrics.

Skills

DSCSA knowledge

Data analysis

Serialization familiarity

Communication

Stress management

Interpersonal skills

Education

Bachelor's degree in IT, Supply Chain or related field

Tools

EPICS

EDI systems

Job description

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

Innovating every day.

Position Summary

The DSCSA Analyst will play a critical role in supporting the compliance of the Drug Supply Chain Security Act (DSCSA) within the organization. The position involves analyzing data, developing and maintaining tracking systems, coordinating implementation activities with current and new partners, and ensuring that all processes align with regulatory requirements. The ideal candidate will possess a strong understanding of pharmaceutical supply chain operations, DSCSA regulations, and data management practices.

Essential Duties & Responsibilities

• Conducting thorough analysis of supply chain data to ensure compliance with DSCSA requirements
• Collaborating with cross functional teams to gather and validate data related to product serialization, traceability, and verification
• Support of client and customer DSCSA implementation with EPICS data file, including generation and communication of test files and moving it into production.
• Interfaces with the EDI team for the support of DSCSA electronic documents
• Troubleshooting and resolving issues related to data discrepancies, system integrations, and processes to ensure compliant operations
• Developing and maintaining documentation and reporting systems to track compliance metrics and activities

Position Requirements

Education Required: Bachelor's degree in IT, Supply Chain, or other related field

Experience Required: Minimum 4 years of experience within the pharmaceutical or healthcare industry, involved with DSCSA compliance.

Skills and Abilities:

• Strong understanding of DSCSA and related regulatory requirements
• Proven expertise with data analysis, reporting, and system troubleshooting
• Familiarity with serialization and traceability processes in pharmaceutical supply chains
• Effective oral and written communication skills
• Ability to work under stress and handle a variety of tasks.
• Excellent interpersonal skills

Salary Range

The expected annual base salary for this New Jersey based position is $80,000 - $100,000. In addition, you may be eligible for a discretionary bonus if you are an active employee on the payment date.

Benefits

Hired applicants will be eligible for benefits, including but not limited to,

• medical
• dental
• vision
• life insurance
• short-term disability
• long-term disability
• 401(k) match
• flexible spending accounts
• health saving account
• employee assistance program
• tuition reimbursement program
• parental leave
• wellness program
• paid time off
• volunteer time
• holidays

Physical Requirements

This role will follow a hybrid work schedule, requiring three (3) onsite days per week at our Bridgewater, NJ office.

Equal Opportunity Employment

Cosette Pharmaceuticals, Inc. is committed to providing equal employment opportunity to all applicants and employees in all phases of our operations. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual's race, creed, religion, color, national origin, citizenship, ancestry, age, sex, pregnancy, childbirth or related medical conditions, gender identity or expression, sexual orientation, marital status, domestic partnership, familial status, reproductive health decisions, status as a victim of domestic violence, stalking, or sexual assault, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, veteran status, liability for service in the United States armed forces, or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.