Principle Medical Writer

Principle Medical Writer

7-10 years
Not Specified

Job Description

Job Summary:
  • The position is designed for Real World Evidence/Study in IVD field, in particular for supporting the implementation of IVD RWS in Hainan Bo'ao. In addition, this position is expected to lead RWE collaboration with authorities and academic institutions.
  • It develops clinical documents for regulatory submissions. The clinical documents include but not limited to: 1) clinical study protocol (CSP), clinical study report (CSR), and clinical evaluation report (CER); 2) The clinical documents cover all Roche Diagnostics in-vitro diagnostic products to be launched in China, including Centralized and Point of Care, Molecular Diagnostics, Tissue Diagnostics, and Diabetes Care.
  • It is keen to drive and contribute insights to the discussion throughout RWE project execution. He/She is also a process owner who manages the authoring projects autonomously and proactively, and establish clear and feasible timelines to meet overall requirements of the regulatory submissions.
  • It is the process owner for the development of the clinical documents. He/she works closely with subject matter experts (SMEs) to achieve high quality, proper format and timely delivery of clinical documents. His/Her performance must strict adherence to company SOPs, Industry standards, and relevant GxPs.

Main Tasks & Responsibilities:
  • Develop clinical documents in order to achieve successful product registration. The clinical documents include but not limited to CSP, ICF, CSR, CSR, RWE, and literature review. Contribute to the scientific content of the clinical documents. In addition, lead the process/workflow of the authoring projects.
  • Provide professional scientific input to study design. Cooperate with internal and external SMEs (statistician, study manager, RA, Roche global expert, NMPA experts, PI etc.) to achieve scientific and feasible study design. Ensure on-time, properly formatted, and high quality delivery of clinical documents with completeness, accuracy and consistency in accordance with all relevant company SOPs/procedures, regulatory requirements, and quality control systems/procedures.
  • Prioritize projects, proactively identify risks and develop mitigation plans for project management.
  • Maintain and improve SOPs, WIs, and templates for the MW team, introduce creative process/new technologies to enhance high quality and agility.
  • Be mentor for junior medical writers. Participates in experience sharing/lessons learnt activities.
  • Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, and Roche Safety. Understand and fulfill SHE tasks and duties (as defined in SHE handbook).

Basic Requirements of the Job:
Education& Qualifications:
  • At least bachelor degree in medical laboratory or above. Candidates with other majors is expected to have master or above degree.
  • Familiar with clinical research, clinical evaluation and relevant regulations, including ICH GCP, IMDRF guidance, NMPA guidelines and standards for in-vitro diagnostics and medical device.
  • Excellent English for both oral and written. Excel in MS word, SharePoint, ShareDoc, and EndNote.

  • At least 7 years experience in medical device or IVD industry. Medical writing experience with a variety of clinical documents, i.e., CSP, CSR, CER etc. The length of the working experience could be reduced for those very outstanding PhD and/or MD.
  • Experience in cooperation with NMPA and academic institution is a must.

Job Details

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