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Medical Writer

3 months ago


Hyderabad, Telangana, India Makro Full time
CompanyDescription: MakroCare is aleading global clinical services organization dedicated tosupporting the life sciences industry in accelerating thedevelopment and commercialization of innovative medical products.With a strong presence in Hyderabad Telangana India our team ofexperienced professionals collaborates with pharmaceuticalbiotechnology and medical device companies to navigate thecomplexities of clinical research and regulatory compliance. AtMakroCare we are committed to excellence integrity and innovationstriving to make a positive impact on healthcare worldwide. Join usin our mission to drive advancements in medical science and improvepatientoutcomes.
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