DSCSA Analyst
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, and 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.