Red Nucleus
Healthcare Insurance • Biotechnology • Pharmaceuticals
Red Nucleus is a company specializing in healthcare and life sciences services, offering a wide range of advisory and scientific services. With over three decades of experience, they provide solutions across the life sciences product life cycle, aiming to improve health outcomes. Their services include market access and commercialization, medical communications, and learning and development. Red Nucleus also offers products like DirectusPRO and iTakeControl. They focus on supporting strategic and operational challenges in healthcare through their expertise in areas like Quality, Clinical, Safety, Regulatory, and Medical Affairs. The company employs a team of over 700 members dedicated to advancing knowledge and improving lives.
Senior Associate Consultant / Consultant
Job not on LinkedIn
November 14
🗣️🇯🇵 Japanese Required
Red Nucleus
Healthcare Insurance • Biotechnology • Pharmaceuticals
Red Nucleus is a company specializing in healthcare and life sciences services, offering a wide range of advisory and scientific services. With over three decades of experience, they provide solutions across the life sciences product life cycle, aiming to improve health outcomes. Their services include market access and commercialization, medical communications, and learning and development. Red Nucleus also offers products like DirectusPRO and iTakeControl. They focus on supporting strategic and operational challenges in healthcare through their expertise in areas like Quality, Clinical, Safety, Regulatory, and Medical Affairs. The company employs a team of over 700 members dedicated to advancing knowledge and improving lives.
📋 Description
• Regulatory Operations Consultant for the pharmaceutical industry • Focus on eCTD publishing, submissions, and document management • Work with regulatory information management systems • Implementation of regulatory technology tools • Collaborate with global teams and clients
🎯 Requirements
• At least 5 years (Sr. Associate), 8-10 years (Consultant) of experience in the pharmaceutical industry with a focus in Regulatory Operations • At least 5 years (Sr. Associate), 8-10 years (Consultant) of experience eCTD publishing, submitting and managing documents for major submissions including electronic study data. • At least 3 years (Sr. Associate), 5 years (Consultant) of experience with global regulatory information management and systems. • Experience assisting with the implementation of a regulatory technology such as, Documentum, Veeva Vault, Insight Manager, Insight Publisher, docuBridge, etc. • Proficient in Microsoft Excel, Word, PowerPoint, Visio and in Adobe Acrobat, Evermap or ISI Toolbox, and eCTD publishing tool. • Fluent in Japanese and English languages.
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