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CER Sr. Specialist/Expert

Job Description

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?

Then come and join our global team as Sr. CER Specialist ,to provide expert medical writing support on Clinical Evaluation Reports (CERs) and contribute medical device registration in China.

 

 

Your Tasks and Responsibilities

·       Contributes to the clinical strategy discussion for product registration and performs competently as medical writing expert on CER, with technical support support from RA and R&D colleagues as needed.

·       Identifies project needs, proposes and tracks project timelines, and takes responsibility for timely delivery of the assigned projects with high quality.

·       Coordinates the activities within clinical documentation development, and aligns cross-functionally with internal teams, (such as RA, BM, complaints team, etc.) as well as external customers/collaborators, to ensure timely completion of deliverables.

·       Participates in both internal and external project team meetings and liaises on medical writing issues. Defines and performs quality control for clinical documentation deliverables.

·       Keeps abreast of current data, trends, regulatory knowledge associated with medical writing as well as the knowledge of the developments and advancements of company’s products. Timely delivers the latest CER related regulation, guidelines, CMDE feedback and concerns to Headquater and RA.

·       Regularly update the internal CER template with new CER requirements about new regulations and CMDE feedbacks.

 

Your Qualifications And Experience

·       Above 3 years’ full-time experience as a medical writer within a multi-national medical device company or CRO. Indepth Knowledge in NMPA CER drafting, review, and medical device registration.

·       Bachelor degree or above relevant in clinical/medical/ biological etc.

 

Our Global Team

Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

Our Culture

Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.

Check our Careers Site at www.healthcare.siemens.com.cn/careers.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started.

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

Organization: Siemens Healthineers

Company: Siemens Healthineers Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

 



Organization: Siemens Healthineers

Company: Siemens Healthineers Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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