MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
Job Description: Senior CER Writer:
- Performing and Reviewing the Gap Assessment for General Safety and Performance
- Requirements and Technical documentation for Medical Devices as per EU MDR
- (Annex I & II).
- Reviewing Medical devices Risk documents (Hazard Analysis report, Risk Management
- Report)
- Design of literature searches to be implemented in electronic literature databases
- Conducting systematic/targeted/structured literature reviews
- Developing and performing database searches and writing protocols and reports for
- literature reviews
- Identifying relevant evidence for research questions (Literature Screening)
- Summarizing literature review findings in a report
- Extracting, analyzing, and summarizing data from a range of sources
- Performing quality checks to ensure data accuracy
- Writing and reviewing of Clinical Evaluation Report documents
- Communicating with the internal project team to ensure smooth and timely execution of
- the project
- Any other jobs and responsibilities assigned from time to time by reporting Manager
Eligible Criteria:
4-8 Years of Experience in CER Writing (Medical writing/Scientific writing)and Abstracts.
Education: Any UG/PG life science background