Job Details
Apply Online | Back To Job Listings
Job Id 07052022
Title Senior CER Writer
Job Type Permanent
City Hyderabad
State Telangana
Zip
Job Description
MakroCare | A MakroGroup Company www.MakroCare.com
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

Qualification Bachelor or Masters Dergree
Experience 4-8 Years
Job Category Medical Writer
Posted On 7/22/2022
Expires On 8/22/2022
 
     Copyright © 2024 Makro. All Rights Reserved.
Privacy Policy   |  Sitemap