Medical Writer- Walk In on 14th at HCL Tech,Hyderabad

1 day ago


Hyderabad, India HCLTech Full time

Dear Candidate,


We are conducting walk – in drive for Medical Writer Role @ Hyderabad office on 14 Dec 2024 . Please confirm your availability.

Please find the below venue details from 9.30 am – 3pm

HCL Technologies Ltd.

H01B, HITEC CITY-2,

Survey No. 30,34,35 & 38.

Phoenix Infocity Pvt. Ltd.

Madhapur, Hyderabad-500081, Telangana. (India)


Recruiter Name: Aswathy Rajan

Contact person: Priyanka Jamanjyothi, Meenakshi Biradar


Job description:

  • Responsible for creation and update of Clinical Evaluation Plans(CEP) and Clinical Evaluation Reports(CER) of Medical Devices as per MEDDEV Rev 4 and MDR regulations.
  • Should have basic experience in handling Post market surveillance reports such as PMS Plan, PMS Report, PSUR, PMCF and SSCP
  • Responsible to work on Protocol development, Clinical study reports, and Investigator’s brochure, Clinical Evidence Summaries, Risk-benefit analysis reports.
  • To perform tasks including literature search, summarizing and analyzing data from clinical studies, consulting, editing statistical and clinical reports
  • Review of medical journals and technical reports
  • Review Protocols, CRF`s, ICF`s and miscellaneous study documentation
  • Working closely with doctors, researchers and other medical services personnel to provide information which is accurate and easy for others to understand
  • Development of disease specific monographs
  • Provide protocol related clinical and scientific information to team members and investigators
  • Review and update CEP, CERs, protocols, case report forms, informed consent forms, Clinical Evidence Summaries, Risk-benefit analysis reports.
  • Serve as primary contact for the assigned medical writing activities
  • Attend medical and project team meetings and client teleconferences as required
  • Interact with other functional units , such as project management , data management and statistics to ensure client satisfaction through successful execution and completion of projects on time and within budget


Regards,

Aswathy



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