长沙招聘

Job Summary:

The Medical Writer oversees delivery/provides input/review of key clinical documents for regulatory submission and other documents not limited to below:

？ Clinical Study Documents

o Clinical study protocols

o Clinical study reports (CSRs)

o Informed consent forms (ICFs)

o Relevant Clinical Validation Plans

？ Documents will cover all Roche Diagnostics in vitro diagnostic products to be launched in China, including Centralised and Point of Care, Molecular Diagnostics, and Diabetes Care.

？ May oversee external vendors to provide writing service for internal MRA projects.

？ Communication/Coordination/Contact point for MRA medical writer’s responsible documents.

The primary focus of the Medical Writer will be on the generation of medical regulatory/scientific content and on the high quality, properly formatted and timely delivery of selected high priority Clinical Study Documents and relevant MRA medical writer’s communications. Successful document completion will require proactive timeline management, cross-functional meeting coordination, effective and assertive communication with subject matter experts (SMEs to provide content), comments resolution, attention to detail, quality control, accountability, and strict adherence to company SOPs, Policies, Directives, Divisional standards, Declaration of Helsinki, Industry standards, relevant GxPs, both CNMPA and/or international requirements and/or best practices.

The Medical Writer will be working closely with relevant stakeholders/SMEs that share the responsibilities for generating, changing and/or updating medical regulatory content. S/He also serve as the primary contact point for most of the documents.

Main Tasks & Responsibilities

1. For selected and high priority medical documents, 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).

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2. 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, regulatory requirements, and quality control systems/procedures.

3. Partners with internal and external SMEs and coordinates cross-functional collaborations/meetings to ensure completeness/accuracy in documentation and meet the defined quality, content and timelines.

4. Monitors quality of assigned work and performs consistent, frequent and through quality control checks.

5. Serves as the primary contact for assigned work and is accountable for ensuring successful completion, including an obligation to report any concerns or completion risks to the Medical Writing Manager.

6. Effectively communicates and builds healthy working relationships with other Medical Writing team members and SMEs with whom he/she will work closely.

7. Successfully completes all assigned curricula and on-the-job training modules.

8. Conduct Other projects or tasks assigned by line manager

9. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection

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Basic Requirements of the Job

Education& Qualifications

1. At least Master’s degree or equivalent in medical related, life science, pharmacology, clinical laboratory or biochemistry.

2. Knowledge and understanding of the clinical research process, including ICH GCP, and NMPA guideline for in vitro diagnostic test.

3. Proficiency in spoken and written English

Experience

1. >3 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports

2. Understanding of regulatory requirements for diagnostics and/or pharmaceuticals with experience working on submissions for new applications to health authority

3. Project management experience

4. Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation

5. Experience working with different document management tools, sharepoint, templates, style guides and expertise with EndNote or equivalent.

熟练使用各种文件管理工具、SharePoint、模板、格式指南，并精通Endnote或类似工具。

Health Conditions 身体状况:

According to the "Quality Management Regulations for Medical Device Management" and the "Regulations on Quality Management of Pharmaceutical Products", health checks should be conducted at least once a year; if you have infectious diseases or other diseases that may contaminate medical devices or drugs shall not be engaged in related work.

Core Competencies 核心能力：

1. Demonstrate Roche values of Integrity, Courage, Passion

2. The Core Competencies is identified as being most crucial for success in this role are:

？ Technical and Business Expertise 

？ Teamwork and collaboration 

？ Decision Making 

？ Achieving Results 

？ Influencing