Medical Writer

Medical Writer – Contract Role SummaryLocation: EST (Remote/Hybrid not specified) Duration: 6-month contract with possible extension or full-time conversionOverviewSeeking an experienced Medical Writer with strong pharmaceutical/biotech/CRO background to create clinical and regulatory documents for drug development programs. The role involves close collaboration with Clinical, Regulatory, Biostatistics, Medical Affairs, and QA teams to ensure documents meet FDA, EMA, ICH, and GCP standards.Key RequirementsAdvanced degree: PhD, PharmD, MD, or MSc in Life Sciences/Medicine/Pharmacy3–5+ years of medical writing experience in pharma, biotech, or CROStrong experience writing:Clinical Study Reports (CSRs)Clinical protocolsNDA/BLA/MAA submissionsCTD summaries and regulatory responsesKnowledge of:ICH, GCP, FDA, EMA guidelinesDrug development phases I–IV (Phase III highly preferred)Clinical research and biostatistics conceptsMedDRA, WHODrug coding dictionariesTools:Microsoft OfficeVeevaEndNote, Adobe Acrobat, regulatory publishing systemsNeurology/Epilepsy experience is a plusMain ResponsibilitiesAuthor and manage regulatory and clinical documents including:Protocols & amendmentsCSRsInvestigator BrochuresInformed Consent FormsCTD modulesNDA/BLA/MAA submissionsSafety reports and regulatory responsesInterpret and present complex clinical/scientific data clearlyEnsure compliance with regulatory standards and submission requirementsCoordinate with cross-functional teams and manage timelinesReview/edit documents for scientific accuracy and regulatory compliancePreferred Candidate ProfileStrong scientific writing and editing skillsDetail-oriented and highly organizedAble to manage multiple projects under tight deadlinesStrong communication and collaboration skillsSelf-motivated with project management abilitiesNice-to-HaveEpilepsy/Neurology therapeutic area expertiseExperience across full drug development lifecycle (Phase I–IV)Regulatory submission experience for global agencies (FDA/EMA)