- 採用企業タイプ 直接採用
- 業種 医療 / 製薬
- Salary ¥700,000 - ¥1,100,000 / 月 (Negotiable)
- 英語レベル 流暢
- 日本語レベル 流暢
- 国内の応募者に限定？ 国内在住応募者のみ
- ビザスポンサーシップ 条件により更新可能
Key competencies include:
- Coordination of customer deliverables across internal Global teams
- Translation of submission requirements and information from Japanese to English and English to Japanese
- Provide global expertise on requirements for electronic document management, submission planning, report publishing, eCTD compilation, and management of approval information.
- Project Management across all R&D contributors to global submissions
- Manage regional Japan eCTD submissions and support global eCTD submissions as a Lead Publisher.
- “Hands-On” submission-ready publishing of documents.
- Proactively communicate requirements and issues to be considered to the Submission Team and contribute to achieving realistic timelines.
- Proactively collect necessary information from the Submission Team and plan all submission management related activities.
- Proactively communicate with clients on submission requirements for eCTD
- Perform quality checking of documents and regulatory submissions to ensure compliance with submission-ready standards.
- Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools.
- Analyze submissions and track and record life-cycle information in accordance with standards.
- Keep updated on regulatory authorities’ requirements on technical/format aspects of submissions worldwide and ensure their incorporation into Red Nucleus standards.
- Participate on or lead special project teams (e.g., skill work, standards).
We are looking for a dynamic, determined Submission lead who can communicate with customers to receive and price project orders
A perfect candidate for this role should have experience assisting with the implementation of a regulatory technology such as, Documentum, Veeva Vault, Insight Manager, Insight Publisher, docuBridge, etc.
• Experience assisting in the migration of documents and submissions from one regulatory system technology to another.
• Proficient in Microsoft Suite software including Excel, Word, PowerPoint, Visio
• Proficient in Adobe Acrobat, Evermap or ISIToolbox, and eCTD publishing tool/system
• Bachelor’s degree (minimum requirement)
The Submission Lead is responsible for the management and coordination of global submission documentation across new and existing accounts. The Submission Lead may also participate in or lead Regulatory Information Management or Systems projects related to global submission documentation. The Submission Lead will be working alongside partners, subject matter experts, and industry specialists to ensure that all deliverables meet customer expectations. The Submission Lead will be expected to actively contribute to business transformation, process optimizations and system improvements. The role will require representation in addressing customer business requirements and needs.
101 Prathamesh, C37 Mohan Nagar, Baner, Pune 411045