Medical Writer

Remote Medical Writer – Clinical & RegulatorySigma Systems is seeking an experienced Medical Writer to support global clinical development programs through the preparation, review, and coordination of high-quality clinical and regulatory documents.This opportunity is ideal for a medical writer with pharmaceutical, biotechnology, or clinical research experience who has strong expertise in clinical development, regulatory writing, scientific writing, ICH guidelines, GCP, and cross-functional project coordination.The Medical Writer will partner with Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and other stakeholders to develop accurate, scientifically sound, submission-ready documents.Position DetailsJob Title: Medical WriterWork Arrangement: 100% RemoteContract Duration: 7 MonthsIndustry: Pharmaceutical / Biotechnology / Clinical ResearchPosition Type: ContractJob SummaryThe Medical Writer will author, edit, review, and coordinate clinical and regulatory documents supporting one or more global clinical development programs.The successful candidate will translate complex scientific and clinical information into clear, accurate, consistent, and regulatory-compliant documentation while managing document timelines, review cycles, stakeholder feedback, and program priorities.This role requires excellent scientific writing skills, strong knowledge of the clinical development lifecycle, attention to detail, and the ability to work independently while influencing and collaborating with cross-functional teams.Key ResponsibilitiesClinical & Regulatory Medical WritingAuthor, edit, and review clinical and regulatory documents, including:Clinical Study ProtocolsProtocol AmendmentsInvestigator Brochures (IBs)Clinical Study Reports (CSRs)Regulatory Briefing BooksIND summary documentsNDA summary documentsRegulatory submission materialsDevelop high-quality documents that align with regulatory requirements, internal standards, and established medical writing plans.Ensure documents support clinical development strategies and program objectives.Interpret complex clinical and scientific information and communicate it clearly for regulatory and clinical audiences.Ensure consistency, accuracy, quality, and completeness across documents.Cross-Functional CollaborationCollaborate with Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and other functional teams.Gather, interpret, organize, and integrate scientific and clinical information.Partner with subject matter experts to ensure accuracy and completeness of content.Facilitate alignment among cross-functional stakeholders throughout the document development process.Resolve reviewer comments and drive consensus while maintaining quality and timelines.Project & Timeline ManagementManage multiple medical writing projects and deliverables simultaneously.Develop and track document timelines in accordance with medical writing plans.Negotiate document milestones and delivery dates with cross-functional stakeholders.Coordinate review cycles and ensure comments are addressed appropriately.Identify potential timeline risks and communicate issues proactively.Balance competing priorities while maintaining document quality and program objectives.Regulatory ComplianceEnsure clinical and regulatory documents comply with applicable regulatory requirements.Apply Good Clinical Practice (GCP) principles and relevant industry standards.Apply applicable ICH guidelines and regulatory guidance to document development.Support regulatory submissions and health authority interactions as needed.Contribute to inspection readiness activities.Maintain high standards of documentation quality, consistency, and regulatory compliance.Process ImprovementContribute to the development and improvement of medical writing processes.Support creation and maintenance of templates, style guides, and standard operating procedures.Identify opportunities to improve medical writing workflows and document development processes.Support continuous improvement initiatives across the medical writing function.Required QualificationsBachelor's degree or advanced degree in a relevant scientific, medical, healthcare, life sciences, or related discipline.Professional experience authoring clinical and regulatory documents.Experience within the pharmaceutical, biotechnology, clinical research, or life sciences industry.Strong understanding of the clinical development lifecycle.Knowledge of regulatory requirements and applicable guidance, including ICH guidelines.Excellent scientific writing, editing, proofreading, and communication skills.Experience developing documents for clinical development programs.Strong organizational and project management skills.Ability to manage multiple projects and deadlines simultaneously.Ability to coordinate and negotiate timelines with cross-functional stakeholders.Strong attention to detail and commitment to document quality.Ability to work independently with minimal supervision.Ability to collaborate effectively with cross-functional teams in a remote environment.Preferred ExperienceCandidates with experience in the following areas are highly desirable:Clinical Study Reports (CSRs)Clinical study protocolsProtocol amendmentsInvestigator Brochures (IBs)IND submissionsNDA submissionsRegulatory briefing booksHealth authority responsesClinical development programsGCPICH guidelinesRegulatory submission documentationInspection readinessMedical writing project management