Sr. Associate Consultant/Consultant (Life Sciences)

TL;DR

Sr. Associate Consultant/Consultant (Life Sciences): Providing strategic learning, performance, and process solutions exclusively for the life sciences industry with an accent on regulatory operations. Focus on eCTD publishing, submitting, and managing documents for major submissions, including electronic study data.

Location: Remote (Japan)

Company

hirify.global is the premier provider of strategic learning, performance, and process solutions exclusively for the life sciences industry.

What you will do

• Focus on Regulatory Operations.
• Assist with the implementation of regulatory technology.
• Manage documents for major submissions, including electronic study data.
• Work collaboratively as part of a team to drive projects forward.

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

Culture & Benefits

• Ability to adapt to the flexibility and fast-paced environment of a global company.
• Capability to manage multiple tasks simultaneously.
• Proactive approach to problem-solving.