The (Sr.) Medical Writer provides input/review of key clinical documents for regulatory submission and other documents that not limited to below: 1) Clinical Study Documents: Clinical study protocols, Clinical study/evaluation reports, Informed Consent Forms (ICFs) and etc.; 2) Might need to hand clinical trials of designated products to be registered.
Areas of Responsibilities:
• Responsible for documents in a particular product area, oversees and manages the entire document and submission lifecycle. This includes kickoff meetings to define assignment scope (content, quality and timelines) with key stakeholders, document template/shell creation, internal review and approval processes (iterative QC checks, version control, team review and comments resolution, finalization and approvals).
• Responsible for the on-time, properly formatted and high quality delivery of clinical study documents and relevant communications in accordance with all relevant company SOPs/procedures and regulatory requirements.
• Partner with internal and external stakeholders and coordinate cross-functional collaborations/meetings to ensure completeness/accuracy in documentation and meet the defined quality, content and timelines.
• Develop and assess of clinical trials level feasibility, forecasting of timelines, estimation and allocation of resources and budget, and development of operational strategies.
• Maintain an overview of status, issues, risks and proactively communicates progress, issues, changes or risk mitigation strategies that may impact timelines and costs of the project to CT manager.
• Lead relevant responsible CRA/CRAs to plan and execute clinical trials to produce high-quality data on schedule in order to satisfy regulatory and registration strategy requirements.
• Act as specific study leader for developing operation manuals/tools, performing co-monitoring visit, budget control and etc.
• Other related tasks assigned by supervisor.
Organization: Siemens Healthineers
Company: Siemens Healthineers Diagnostics (Shanghai) Co., Ltd.
Experience Level: Experienced Professional
Job Type: Full-time