COMPANY DESCRIPTION: Red Nucleus is the premier provider of strategic learning, performance, and process solutions exclusively for the life sciences industry. Our global solutions engage and inspire teams across the R&D, Medical Communications, and Commercial spaces and are designed to boost understanding, efficacy, and compliance. Squarely focused on the life sciences industry for more than 30 years, Red Nucleus takes pride in our long-term relationships with industry leaders, as well as our strategic partnerships with innovative startups. We are focused on developing thoughtful, high-quality solutions that are in accordance with each client's unique culture and process. Our clients trust us to build impactful, award-winning programs that deliver actionable insights and measurable results.
Our purpose at Red Nucleus is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific and strategic advisory services, and medical communications solutions for the life sciences industry. Our global team is composed of nearly 900 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space.
Job Title: Sr. Associate Consultant or Consultant
Key Skills/Phrases:
Regulatory Operations
- At least 5 years (Sr. Associate), 8-10 years (Consultant) of experience in the pharmaceutical industry with a focus in Regulatory O
- 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
Desired Attributes:
- Ability to adapt to the flexibility and fast-paced environment of a global company
- Capability to manage multiple tasks simultaneously
- Ability to work collaboratively as part of a team to drive projects forward
- Proactive approach to problem-solving
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Skills Required
- At least 5 years of experience in the pharmaceutical industry focused on Regulatory Operations
- At least 5 years of experience in eCTD publishing
- At least 3 years of experience with global regulatory information management and systems
- Experience with regulatory technology implementation
- Proficiency in Microsoft Office Suite and Adobe Acrobat
- Fluency in Japanese and English languages
What We Do
Advancing knowledge to improve lives.™ We are a global strategic partner with decades of experience across the entire life sciences product lifecycle. We excel in providing our clients with unique insights and efficiencies to support them in their journey to improve health outcomes and ultimately the quality of people’s lives. By connecting our full suite of products and services from scientific and advisory services, market access, medical communications and learning and development, we are the “red thread” to lead our life sciences clients through transformational change to accelerate customer success. Visit the new rednucleus.com to learn more
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