锦鲤求职岗位描述
YOUR TASKS AND RESPONSIBILITIES
The role entails providing support including content check and technical expertise to submission and clinical development projects.
The incumbent is responsible for supporting documentation of submission and clinical development projects by working with Medical Writers and clinical teams to help ensure high-quality, timely deliverables.
Key work relations internal/external (internaland external partners/customers)
Medical writing roles Clinical Regulatory Submission Team members Clinical Trial Transparency External vendors
Scope (global, regional or local) Japanese market & Global
Works in the global team to provide content and technical quality control (QC) to CSP, CSR and submission documents or other documents in scope of medical writing and ensures the filing of supporting documents in compliance with Health Authority requirements, GCP, and internal procedures.
Works in the global team to compile CSR appendices, and coordinates the CSR publishing Provides QC for redaction (PPD and/or CCI) or translation of submission documents Supports the technical platform of Medical Writing, including but not limited to the support of document management system, maintaining the related templates, and literature reference libraries.Coordinating global or regional QC teams to ensure the delivery of high-quality documents for clinical research and regulatory submission projects.
Systems: Maintain and update templates, EndNote libraries and technical platforms, e.g. document management system, document review/comment system
Advisor: Provide content and technical expertise to the submission and clinical transparency projects
Vendors: Collaborate with vendors including issue management
Processes: Drive process improvements, simplification, acceleration and digital innovation and translation to updated system requirements
Training: Deliver onboarding and training on applicable submission guidelines, processes and systems
Best Practice: Support development of best practices documents, user guides and internal training materials
Planning: Support resource estimation and planning
DSO behaviors: Act as a role model for our DSO behaviors - Focus on outcomes, be our best selves and include others, collaborate with accountability, co-create for customers; act, learn fast and evolve
WHO YOU ARE
Education: Bachelor degree or working experience in the research or pharmaceutical industry, preferably advance degree
Project management: Strong organizational skills with the capacity to manage multiple projects simultaneously and to adapt to changing priorities
Experience: Experience working in a global environment is preferred. Experience with content/ document management is preferred. Auditing, inspection, or quality management experience would be a plus.
Collaboration: The incumbent must be able to work effectively in teams and feel comfortable interacting with people in all hierarchy levels.
Communication skills: Strong verbal and written communication skills in Japanese & English and ability to explain complex technical topics in a simplified way
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