- 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
Apply : https://careers.labcorp.com/global/en/job/2021-78169_CP/Spec-II-PSS
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