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Medical Writer
2 days ago
JobTitle: MedicalWriterLocation:Hyderabad Telangana India(OnSite)
PositionOverview:
- As aMedical Writer at MakroCare the role in the development and reviewof clinical and regulatory documents essential for the advancementof medical research and product development. Your responsibilitieswill include writing and reviewing a variety of documents such asclinical trial protocols clinical study reports investigatorbrochures and informed consent forms ensuring adherence toestablished guidelines and regulations.
- Additionally you will contribute to postmarketsurveillance activities participate in manuscript and abstractwriting and assist in the development of templates for regulatorydocuments. This position offers an exciting opportunity to utilizeyour expertise in medical writing to support the development ofinnovative healthcaresolutions.
Responsibilities:
- Writeand review clinical/regulatory documents such as clinical trialprotocols clinical study reports/Clinical evaluation reportsinvestigator brochures and informed consent forms in accordancewith ICH or other relevant guidelines.
- Draftand document CSR (Clinical Study) and CER (Clinical Evaluation)modules.
- Participate in the writing ofpublication manuscripts abstracts posters andpresentations.
- Conduct routine systematicliterature reviews for specific medical device groups or subgroupsincluding screening articles against inclusion/exclusion criteriaextracting data from included studies interpreting study resultsand preparing summaries into formalreports.
- Develop templates for reports andother regulatorydocuments.
Education&Qualifications:
- Bachelorsor Masters degree in Life Sciences or BDS/MDS (Bachelors/Masters ofDental Surgeon)
- Minimum of 13 years ofexperience in Medical Writing (CSR/CER) or a relatedfield.
csr,medicalwriting,clinical research,evaluation tools,investigatorbrochures,lifesciences,healthcare,manuscript,abstracts,publishing
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