Job Description

Position Summary:
We are looking to add an experienced Clinical Writer to our team. The person in this position must be able to independently contribute to the development of initial and update(s) of CER\xe2\x80\x99s that support the applicable regulatory submission requirements for the medical device products.

An experienced Clinical Analyst professional has relevant medical/life-science qualification and knowledge/direct clinical experience in the use of the device or device type in a clinical setting. The expected experience is 4 - 6 years with a minimum of 1 \xe2\x80\x93 2 years of CER writing experience is essential. A minimum of 1 \xe2\x80\x93 2 years of medical writing/reviewing experience is needed. The experience is expected to be current or recent (preferably within the past two years), to provide confidence in their experience considering the rapid nature of updates/changes in the regulatory landscape, the device, its functionalities and the therapy area. Mandarin language skill is mandatory-to read and analyze Mandarin literature articles; author regulatory submission documents in Mandarin; timely response to HA queries in Mandarin.

Preferred Education: Masters\xe2\x80\x99 degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience

Preferred Experience:
1. The expected experience is 4 \xe2\x80\x93 6 years with minimum 1 \xe2\x80\x93 2 years of CER writing and reviewing experience. Significant experience writing scientific, medical/clinical, and technical content. Also, a plus would be experience with writing CERs that conform to MEDDEV 2.7/1.

2. Knowledge in the therapeutic area \xe2\x80\x93 specifically in the field of diagnostic radiology, interventional radiology and radiation oncology

3. Familiarity with various country specific standards and regulations for medical devices to be able to assess and provide device appropriate clinical evaluation data for registrations.

4. Chinese/Mandarin language skills- read and translate literature articles, documents, queries in Mandarin to English; write clinical evaluation and other regulatory documents in Mandarin; translate English documents to Mandarin.

Duties and Responsibilities

1. Collaborate with the project/program stakeholders for product knowledge and information to develop quality content for the CER\xe2\x80\x99s and within the required timelines.

2. Screen and summarize literature for relevant clinical data

3. Review literature to elucidate the clinical problem and current treatment techniques

4. Study and report device characteristics and instructions for use

5. Evaluate data for similar competitor devices

6. Summarize post-marketing surveillance and risk management data for the target device

7. Able to work in cross functional teams with strong communication, presentation & interpersonal skills

8. Analytical thinking skills with strong demonstration of scientific writing and verbal communication.