Clinical Affairs Professional

2 Applied
Job Description


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's 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 - 2 years of CER writing experience is essential. A minimum of 1 - 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. Preferred Education: Masters degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience Preferred Experience: 1. The expected experience is 4 - 6 years with minimum 1 - 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 - 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. Duties and Responsibilities 1. Collaborate with the project/program stakeholders for product knowledge and information to develop quality content for the CER's 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. Organization: Siemens Healthineers Company: Siemens Healthcare Private Limited Experience Level: Mid-level Professional Full / Part time: Full-time

Siemens Technology and Services Private Limited (STSPL) is the Indian subsidiary of German multinational engineering and electronics conglomerate Siemens that focuses on IT and management services. The subsidiary is split into four units: Corporate Technology India, Siemens Corporate Finance and Controlling, Global Shared Services, and Siemens Management Consulting. Located in Electronic City in Bangalore, it has over 5000 employees. It has been certified with an SEI-CMMi Level 3, PCMM Level 3, ISO 27001:2013 (ISMS) and ISO 9001 certifications.

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