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Job Description
About Cetas Healthcare:
Cetas Healthcare works closely with top Med Tech companies such as GE Healthcare, Boston Scientific, J&J, Medtronic, Philips, Roche Diagnostics,
Cetas Healthcare is a preferred market research vendor for many of our Med Tech We are preferred primarily for expertise in the MedTech industry & for the capability to design and execute complex market research studies in multiple
Job Responsibilities:
; QC of Regulatory documents (including but not limited to CSR, Narratives, CTD Modules, Investigator s Brochure, Protocol)
; Ensure that the Quality checked documents are in accordance with the company SOPs, guidelines, and agreed timelines and comply with established standards and performance metrics
Perform the project management activities for the project/ document assigned
Develop and maintain effective working relationships and facilitate communication among the project team members
; Identify issues and implement corrective and preventive ;
Impart training and mentor and groom the new incumbents, develop the therapeutic area, and document expertise
Requirements
Preferred Experience:
Minimum 1 to 2 years experience in medical writing
Knowledge of Medical Device, basic understanding of European Medical Device Regulation (EUMDR).
Exposure to Post Market Clinical Follow up (PMCF) Studies for Regulatory
Experience in analysis, interpretation, and reporting the scientific data (analytical thinking).
Experience in working with EU regulatory agencies preferred
Exposure to multiple therapeutic areas
Excellent written and verbal communication
Job Location: Mumbai
Preferred Experience: Minimum 1 to 2 years experience in medical writing Knowledge of Medical Device, basic understanding of European Medical Device Regulation (EUMDR). Exposure to Post Market Clinical Follow up (PMCF) Studies for Regulatory Experience in analysis, interpretation, and reporting the scientific data (analytical thinking). Experience in working with EU regulatory agencies preferred Exposure to multiple therapeutic areas Excellent written and verbal communication Job Location: Mumbai Qualification: Pharm, Pharma, PhD, BDS, BIO Medical Engineering, Life Science s
Employment Type
Full Time
