Medical Writer

Year    Navi Mumbai, Maharashtra, India

Job Description

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Efficiency in conducting literature searches for authoring various types of reports
\xef\x80\xad Write various safety reports (or part of such reports) for global regulatory submissions for Sciformix\xe2\x80\x99s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other clinical documents as assigned.
\xef\x80\xad Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
\xef\x80\xad Write Investigator Brochures and sections of/entire protocols
\xef\x80\xad Write Clinical Study Reports (in whole or in part) for Ph 1-4 trials, including fullMaster\xe2\x80\x99s degree in Pharmacy/related science area
\xef\x80\xad Bachelor\xe2\x80\x99s degree in Medical Science
\xef\x80\xad At least 3 years of experience in the pharmaceutical industry, with at least 2 years of it in medical writing study reports, abbreviated reports, web synopses
\xef\x80\xad Author Informed Consent Forms (ICFs), manuscripts, abstracts, posters for conferences,
\xef\x80\xad Prepare medical information responses for HCPs
\xef\x80\xad Write subject narratives for adverse drug reactions and serious adverse events
\xef\x80\xad Internal and external (client) communication & co-ordination to get the required inputs
\xef\x80\xad Creating and updating labels, e.g. Core Data Sheets, USPI, centralized SPC\xe2\x80\x99s, Med Guides
\xef\x80\xad Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document Labcorp is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement.

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Job Detail

  • Job Id
    JD3034984
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Navi Mumbai, Maharashtra, India
  • Education
    Not mentioned
  • Experience
    Year