Spec I Pss

2 days ago


Navi Mumbai, India Labcorp Full time

Bachelors - Life sciences 2-4 Years

Efficiency in conducting literature searches for authoring various types of reports
 Write various safety reports (or part of such reports) for global regulatory submissions for Labcorp’s 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
 Internal and external (client) communication & co-ordination to get the required inputs
 Creating and updating labels, e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides

**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.

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