Life Sciences Clinical Affairs at Siemens Healthineers – Apply Now
Clinical Affairs Professional
Bengaluru, Karnataka, India
Job Description
Job ID: 425920
Company: Siemens Healthcare Private Limited
Organization: Siemens Healthineers
Job Family: Quality Management
Experience Level: Mid-level Professional
Full Time / Part Time: Full-time
Remote vs Office: Office/Site Only
Contract Type: Permanent
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 CERs that support the applicable regulatory submission requirements for medical device products.
An experienced Clinical Analyst professional has relevant medical/life-science qualifications and knowledge or 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 being 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
- Master’s degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience.
Preferred Experience
- The expected experience is 4-6 years with a minimum of 1-2 years of CER writing and reviewing experience.
- Significant experience in writing scientific, medical/clinical, and technical content.
- Experience with writing CERs that conform to MEDDEV 2.7/1 is a plus.
- Knowledge in the therapeutic area – specifically in the field of diagnostic radiology, interventional radiology, and radiation oncology.
- 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
- Collaborate with the project/program stakeholders for product knowledge and information to develop quality content for CERs within the required timelines.
- Screen and summarize literature for relevant clinical data.
- Review literature to elucidate the clinical problem and current treatment techniques.
- Study and report device characteristics and instructions for use.
- Evaluate data for similar competitor devices.
- Summarize post-marketing surveillance and risk management data for the target device.
- Work in cross-functional teams with strong communication, presentation, and interpersonal skills.
- Demonstrate analytical thinking skills with strong scientific writing and verbal communication.
Link to apply: Apply Now
Keywords: Clinical Affairs Professional, Siemens Healthineers, Clinical Writer, CER, Medical Device, Bengaluru, Karnataka, India. Life Sciences Clinical Affairs at Siemens Healthineers – Apply Now. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook