Job title: Medical Writer
Company: Tata Consultancy Services
Job description: Job Description * Experience in Regulatory Writing in any of the below mentioned areas oAuthoring of Clinical Study protocols, Clinical study reports, clinical overviews, Clinical Summaries or Investigator’s Brochures oExperience in Clinical Tri
Job Description Experience in Regulatory Writing in any of the below mentioned areas oAuthoring of Clinical Study protocols, Clinical study reports, clinical overviews, Clinical Summaries or Investigator’s Brochures oExperience in Clinical Trial Disclosures for Clinical Trials.gov, EudraCT etc. oWriting and review of Aggregate Reports, DSURS, PSURs, PBRERS, RMPs, REMS, etc. oExperience in Product Labels, CCDS, SMPC, USPI, IPI etc. oWriting HEOR reports, 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 MS office (Word, Excel, PowerPoint) Job Description: .Responsible for development of standard content to be used in the various clinical documents .Should be able to analyze the content reuse across multiple regulatory submission documents (protocols, CSRs, overviews, etc.) .Should be able to identify and analyze content within the specified content area. .Responsible for identification of key outputs in content categorization .Is accountable for content analytics. .Development of content categories and category treeDesired Candidate Profile BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), MASTER OF PHARMACY, MASTER OF PHILOSOPHY
Expected salary:
Location: Mumbai, Maharashtra
Job date: Mon, 04 Jul 2022 22:58:36 GMT
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