Job title: Medical Writer

Company: Tata Group

Job description:

• Experience in Regulatory Writing in any of the below mentioned areas oAuthoring ofClinical Study protocols, Clinical study reports, clinical overviews, ClinicalSummaries or Investigator’s Brochures oExperiencein Clinical Trial Disclosures for C

Experience in Regulatory Writing in any of the below mentioned areas oAuthoring ofClinical Study protocols, Clinical study reports, clinical overviews, ClinicalSummaries or Investigator’s Brochures oExperiencein Clinical Trial Disclosures for Clinical Trials.gov, EudraCT etc. oWriting andreview of Aggregate Reports, DSURS, PSURs, PBRERS, RMPs, REMS, etc. oExperiencein Product Labels, CCDS, SMPC, USPI, IPI etc. oWriting HEORreports, Global value Dossiers, AMCP dossiers Good verbal and written communication skills Should be able to manage assigned activities independently, with minimal oversight Develop and maintain effective working relationships and facilitate communication among the project team members, identify issues and implement corrective and preventive action Should have experience in working with MSoffice (Word, Excel, PowerPoint) Job Description: Responsible fordevelopment of standard content to be used in the various clinical documents Should be able toanalyze the content reuse across multiple regulatory submission documents(protocols, CSRs, overviews, etc.) Should be able toidentify and analyze content within the specified content area. Responsible foridentification of key outputs in content categorization Is accountablefor content analytics. Development ofcontent categories and category tree

Expected salary:

Location: Mumbai, Maharashtra

Job date: Wed, 06 Jul 2022 22:44:58 GMT

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