Spec Ii Pss

Year    Mumbai, Maharashtra, India

Job Description


  • Master\'s degree in Pharmacy/related science area - Bachelor\'s degree in Medical Science - At least 5 years\' experience in the pharmaceutical industry, with at least 3 years of it in medical writing - Experience in drug discovery and pharmacovigil
Master\'s degree in Pharmacy/related science area - Bachelor\'s degree in Medical Science - At least 5 years\' experience in the pharmaceutical industry, with at least 3 years of it in medical writing - Experience in drug discovery and pharmacovigilance is desirable Write various safety reports (or part of such reports) for global regulatory submissions for clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other clinical documents as assigned. Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned. Write Investigator Brochures and sections of/entire protocols Write Clinical Study Reports (in whole or in part) for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses Author Informed Consent Forms (ICFs), manuscripts, abstracts, posters for conferences, Prepare medical information responses for HCPs Write subject narratives for adverse drug reactions and serious adverse events Creating and updating labels, e.g. Core Data Sheets, USPI, centralized SPC\'s, Med Guides 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.

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Job Detail

  • Job Id
    JD3008725
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Mumbai, Maharashtra, India
  • Education
    Not mentioned
  • Experience
    Year