Remote R&D Technical Writer

Clinical Regulatory Writer / Documentation Specialist (Remote) OverviewWe are seeking an experienced Clinical Regulatory Writer / Documentation Specialist to support the development, coordination, and completion of critical clinical and regulatory documentation in a fully remote environment. This individual will play a key role in ensuring high-quality, accurate, and timely preparation of clinical reports, summary documents, package inserts, and other regulatory materials supporting product development and submissions.This is an individual contributor role requiring strong technical writing expertise, attention to detail, and the ability to work independently with minimal supervision. The ideal candidate brings a solid understanding of clinical and pre-clinical documentation processes along with strong project coordination and timeline management skills.ResponsibilitiesDevelop, edit, review, and finalize clinical and regulatory documents including:Clinical study reportsSummary documentsPackage insertsTechnical and scientific documentationSupporting regulatory submission materialsCoordinate and support electronic regulatory submission activities as neededEnsure documents are accurate, compliant, and aligned with internal standards and regulatory requirementsProvide recommendations for document formatting, templates, and documentation guidelinesOffer guidance and direction to cross-functional teams regarding the development and completion of clinical and pre-clinical documentsManage document timelines and deliverables to ensure timely completion of projectsCollaborate with clinical, regulatory, quality, and scientific stakeholders throughout the document lifecycleReview and analyze technical information to ensure clarity, consistency, and completenessMaintain strong attention to detail while balancing multiple priorities and deadlinesQualificationsRequired QualificationsBachelor’s degree or equivalent combination of education and experienceMinimum of 4 years of experience in clinical, regulatory, or technical writing within a regulated environmentExperience developing clinical and/or pre-clinical documentationStrong understanding of regulatory documentation standards and processesExcellent written and verbal communication skillsAbility to work independently and manage multiple projects simultaneouslyStrong organizational skills and attention to detailExperience managing timelines and coordinating document deliverablesPreferred QualificationsExperience supporting electronic regulatory submissionsFamiliarity with pharmaceutical, biotechnology, or medical device industriesKnowledge of regulatory agency expectations and submission requirementsExperience working in cross-functional clinical or regulatory teamsAdditional InformationFully remote opportunityIndividual contributor role with significant autonomy and ownershipFast-paced, collaborative environment supporting critical clinical and regulatory initiatives