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CSR Narrative Writing Consultant

1.00 to 3.00 Years   Delhi   11 May, 2023
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaService / Installation / Repair
EmploymentTypeFull-time

Job Description

    • Responsible for writing safety documents intended for submission to regulatory agencies.
    • Responsible for writing patient CSR narratives and producing high quality documents
    • Practices excellent internal and external customer service
    • Good understanding of MS Word for advanced writing techniques
    • Address client comments during document lifecycle, manage revisions, and review deliverables with limited mentor oversight prior to releasing to client
    • Ensure documents comply with appropriate ICH and regulatory guidelines
    • Interact directly and independently with client
    • Ability to follow MMS and sponsor processes
    • Practices internal and external leadership skills
    Requirements
    • Over 3 years experience writing CSR narratives
    • College graduate in scientific, medical, clinical discipline or related field, or related experience
    • Prior medical/ narrative/ safety writing experience preferred; Interested in expanding knowledge of drug development as it pertains to narrative writing
    • Master s or PhD in a scientific, medical, or clinical discipline preferred
    • 1-3 years experience with regulated scientific/clinical or pharmaceutical, biotech or clinical research environment
    • Understands ICH guidelines, as applicable to writing for clinical studies
    • Excellent written English skills
    • High degree of organization and able to manage multiple projects at any given time
    • Attention to detail and committed to excellence in all aspects of their work
    • Excellent communication and interpersonal skills
    • Proficient in Microsoft Word and Adobe Acrobat
    • Experience in the use of an Electronic Document Management system
    ,

Keyskills :
global healthmicrosoft worddrug developmentclinical researchdocument managementelectronic document

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