FDA Attorney
Pine Brook, NJ · On-site +1
In the Life Sciences, Firm X, has represented pharmacies of all kinds and assisted with regulatory ... fully remote office. They receive an average of 5 new FDA client inquiries per week.
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FDA Attorney
Pine Brook, NJ · On-site +1
In the Life Sciences, Firm X, has represented pharmacies of all kinds and assisted with regulatory ... fully remote office. They receive an average of 5 new FDA client inquiries per week.
Remote Pharmaceutical Serialization information
What is remote pharmaceutical serialization?
Remote pharmaceutical serialization refers to the process of assigning and managing unique serial numbers to drug products using digital tools and software, often performed off-site or via cloud-based platforms. This helps track and trace pharmaceuticals throughout the supply chain, ensuring compliance with global regulations and preventing counterfeit medicines. Professionals in this role typically oversee serialization data, coordinate with manufacturers, and ensure that all systems meet regulatory standards, all while working remotely.
What are the key skills and qualifications needed to thrive in remote pharmaceutical serialization?
To thrive in Remote Pharmaceutical Serialization, you need a solid understanding of pharmaceutical supply chain regulations, data management, and quality assurance, often supported by a degree in pharmacy, life sciences, or engineering. Familiarity with serialization software (such as SAP ATTP, TraceLink), barcode and RFID technologies, and compliance standards like DSCSA or EU FMD is essential. Strong analytical thinking, attention to detail, and effective communication help professionals collaborate across remote teams and ensure regulatory compliance. These skills are crucial to maintain product integrity, prevent counterfeiting, and support a secure, traceable pharmaceutical supply chain.
What are some common challenges faced by professionals working in remote pharmaceutical serialization roles, and how can they be addressed?
Professionals in remote pharmaceutical serialization roles often encounter challenges such as coordinating with cross-functional teams across different time zones, ensuring data integrity and compliance with global regulations, and managing serialization software remotely. To address these challenges, it's important to establish clear communication channels, participate in regular virtual meetings, and stay updated with the latest regulatory changes. Utilizing robust project management tools and maintaining thorough documentation also helps in streamlining workflows and ensuring successful serialization processes.
What is the difference between Remote Pharmaceutical Serialization vs Remote Pharmaceutical Packaging Operator?
| Aspect | Remote Pharmaceutical Serialization | Remote Pharmaceutical Packaging Operator |
|---|---|---|
| Credentials | Knowledge of serialization systems, GMP compliance, technical skills | Training in packaging processes, GMP standards, equipment operation |
| Work Environment | Office-based, IT-focused, system monitoring | Remote or on-site, packaging line supervision |
| Industry Usage | Pharmaceutical manufacturing, serialization compliance | Pharmaceutical packaging lines, production facilities |
| Search & Comparison Intent | Understanding serialization roles, compliance tasks | Packaging processes, operational roles |
Remote Pharmaceutical Serialization involves managing serialization systems, ensuring compliance, and working with digital tracking technologies. In contrast, Remote Pharmaceutical Packaging Operators focus on overseeing packaging lines and ensuring proper packaging procedures. Both roles are essential in pharmaceutical manufacturing but differ in technical focus and daily tasks.
What are popular job titles related to Remote Pharmaceutical Serialization jobs in Newark, NJ?
For Remote Pharmaceutical Serialization jobs in Newark, NJ, the most frequently searched job titles are:
What job categories do people searching Remote Pharmaceutical Serialization jobs in Newark, NJ look for?
The top searched job categories for Remote Pharmaceutical Serialization jobs in Newark, NJ are:
Full-time
Medical, Dental, Vision, Retirement, PTO
Re-posted 13 days ago
Job description
TITLE: FDA ATTORNEY POSITIION: DIRECT HIRE Firm X, established in 2000, is a national boutique law firm focused exclusively on Healthcare and Life Sciences. The Firm draws on its experience representing stakeholders across the entire healthcare spectrum. In the Life Sciences, Firm X, has represented pharmacies of all kinds and assisted with regulatory, transactional, and litigation matters. On the Healthcare side, the Firm's clients have included large physician group practices, hospitals, hospital medical staff, ambulatory surgery centers, laboratory companies, as well as the complete panoply of ancillary service providers. Firm X attorneys are licensed in numerous states. The Firm has offices in Pine Brook, New Jersey, and New York City. A Mid-Level or more senior FDA Attorney (Counsel-level or higher) is sought for Firm X’s Pine Brook, NJ, New York City, or fully remote office. They receive an average of 5 new FDA client inquiries per week. Responsibilities will align with the Attorney’s background, which should include: • Compounding rules, regulations and FDA guidance o 503A o 503B o Bulk API suppliers and repackagers o FDA audits/investigations • Drug supply chain security and track and trace o Trading partner requirements o Unique trading partners (i.e., 3PLs, brokers, etc.) o Serialization implementation requirements o Other drug supply chain considerations • Drug and device manufacturing rules o CGMP compliance o NDA and ANDA filings and evaluation o 510K Premarket Approval Filings and evaluation o OTC filings and evaluation o Advice on manufacturing practices • Clinical trial rules o Structuring and drafting clinical trial agreements, informed consent forms, master service agreements, and related research contracts o Institutional Review Board (IRB) submissions and compliance o Clinical trial design, study initiation, data use, adverse event reporting, and post-trial obligations • Labeling and advertising reviews • FDA registration and annual filings • FDA inspections, 483 responses and warning letters • Drug withdrawals and recalls • FDA importation and exportation rules • Veterinary medicine and veterinary compounding • Dietary supplements • FDA regulated medical devices • Reviews of clinical literature and incorporation into arguments/strategies (access to these clinical literature directories is a plus) Requirements: • 10+ years FDA experience – private law firm experience strongly preferred, but will also consider in-house candidates • Clinical trial experience a plus • Filing copyrights a plus • Filing patents a plus • May work in the Pine Brook or New York City office; will also consider fully remote arrangement if located in other states • Admitted to practice in at least one US state • Experience performing most/all of the job responsibilities of the position (outlined above) • Team-player mindset, and ability to work cohesively and collaboratively with a team of attorneys • Strong work ethic Benefits: Firm X offers a hybrid schedule, competitive salary, and a full range of benefits, including PTO, medical, dental, vision, 401(k) (upon eligibility to participate), on-site gym (Pine Brook), and opportunities for substantial salary progression based on performance and contributions. *The posted salary will depend on years of experience and other factors.