Senior Regulatory Medical Writer / QC Reviewer

Location: RemoteCompensation: $75–90/hour | 6+ Month ContractScientific Search has partnered with a clinical-stage biotechnology company advancing innovative therapies for serious and rare diseases. We are seeking experienced Regulatory Medical Writing professionals with deep expertise in document quality control, regulatory submission support, and M2/M3 regulatory documentation.This role will support high-visibility regulatory and clinical programs and requires a detail-oriented professional who thrives in a fast-paced biotech environment with strong cross-functional collaboration.ResponsibilitiesPerform high-level QC review and editing of clinical and regulatory documents to ensure accuracy, consistency, formatting, and compliance with FDA, ICH, eCTD, and internal standardsReview and support authoring activities for regulatory submission documents including:M2 and M3 modulesClinical summariesINDs, NDAs, BLAsAnnual reportsInvestigator Brochures DSURsProtocolsClinical Study Reports (CSRs)Health authority responsesVerify data accuracy against source documentation and ensure submission readiness across all deliverablesCollaborate closely with Regulatory Affairs, Clinical Development, Pharmacovigilance, Medical Writing, and external vendors to manage document review cycles and resolve comments efficientlyEnsure consistency with AMA style guidelines, company templates, publishing standards, and global regulatory requirementsSupport eCTD submission activities and document management workflows within Veeva Vault and related systemsContribute to SOP development, process improvement initiatives, QC checklists, and best practices for regulatory documentation and review processesAssist with timeline management and ensure deliverables are completed according to aggressive submission schedulesRequirementsBachelor’s degree in life sciences or related discipline required; advanced degree preferred5+ years of experience in regulatory medical writing, regulatory operations, or medical writing QC within biotech, pharmaceutical, or CRO environmentsStrong hands-on experience reviewing and supporting M2/M3 regulatory submission documents requiredExperience supporting IND, NDA, BLA, or global regulatory submissionsStrong understanding of FDA, ICH, eCTD, and global regulatory submission requirementsExperience with Veeva Vault, eCTD publishing environments, and document management systems strongly preferredExceptional attention to detail with strong proofreading, editing, and document QC capabilitiesAbility to work independently in a highly collaborative and deadline-driven environmentPreferred ExperienceExperience supporting both clinical and nonclinical regulatory documentationBackground in rare disease, hematology, oncology, or specialty therapeutics preferredExperience working in small biotech or fast-paced clinical-stage organizations highly desirableHow To ApplyWe’d love to see your resume, but we don’t need it to have a conversation.Email tom@scientificsearch.com or message me directly to learn more. - REMOTE