Manager, Global Document Management

🔥 27 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $107.7k - $161k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Support the development, implementation, continuous improvement and documentation of Otsuka Companies’ Quality System • Support inspections including preparation for GxP inspections and responses to Regulatory Authorities • Manage global, regional and local Standard Operating Procedures (SOPs) and Working Practices (WPs) • Provide advice and act as project liaison for project activities

🎯 Requirements

• Degree in natural science or equivalent number of years’ experience • 4+ years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation • Advanced knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance • Experience in Monitoring, Quality Assurance and/or Good Clinical Practices

🏖️ Benefits

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • A generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs as well as other company provided benefits