Senior Medical Writing Manager

AllSTEM Connections is seeking a Senior Medical Writing Manager to work onsite in Plainsboro, NJ.This is a seven-month contract position. Possible extension/temp-to-hire.Hourly rate is up to $105/hour. SUMMARY:The Senior Manager, GDS&PV Medical Writer (Contractor) will independently author, review, and finalize clinical and regulatory documents supporting clinical development and regulatory submissions. This role will lead medical writing activities, collaborate with cross-functional teams, manage document timelines and reviews, and contribute to the development of medical writing standards and processes in accordance with applicable regulatory requirements.RESPONSIBILITIESClinical and Regulatory Document DevelopmentIndependently author, edit, review, and finalize complex clinical and regulatory documents, including clinical trial protocols and amendments, investigator’s brochures, clinical study reports (CSRs), clinical synopses, and pediatric investigation plans (PIPs).Prepare clinical overviews, summaries, and other clinical documentation in CTD/eCTD format to support regulatory submissions.Draft and edit Health Authority briefing documents, briefing books, responses, and other regulatory submission materials.Prepare and review scientific publications, including abstracts, posters, slide presentations, and manuscripts.Interpret and communicate complex clinical and scientific data clearly, accurately, and consistently for regulatory and scientific audiences.Medical Writing Leadership and Project ManagementServe as compound lead writer and Medical Writing representative on cross-functional clinical development and regulatory teams.Provide guidance on document strategy, content, timelines, and resource requirements to ensure high-quality, timely deliverables.Lead or participate in regulatory submission activities, coordinating document planning, cross-functional reviews, reviewer comments, and resolution of document-related issues.Manage document development from initial templates through review, approval, and finalization, including meeting coordination, review schedules, and decision tracking.Process Development and Continuous ImprovementDevelop and maintain medical writing templates, standards, and processes.Recommend and lead process improvement initiatives to enhance document quality, efficiency, and cross-functional and global collaboration.Share best practices, lessons learned, and technical knowledge through departmental initiatives and interdepartmental knowledge-sharing activities.Regulatory Compliance and QualityMaintain current knowledge of applicable regulatory guidelines, ICH guidelines, and global submission requirements.Ensure clinical and regulatory documents comply with applicable guidelines, standard operating procedures (SOPs), internal practices, and technical standards.Maintain relevant therapeutic-area and medical writing expertise.QUALIFICATIONSApproximately 6–8+ years of medical writing experience within the pharmaceutical or biotechnology industry, including independent authorship and leadership of complex clinical and regulatory documents.Demonstrated experience authoring and reviewing clinical trial protocols, investigator’s brochures, clinical study reports, clinical summaries or overviews, briefing documents, and Health Authority responses.Strong understanding of clinical development, regulatory submission requirements, CTD/eCTD structure, ICH guidelines, and applicable global regulatory requirements.Experience leading medical writing activities for regulatory submissions, including document planning, cross-functional reviews, timeline management, and resolution of complex reviewer comments.Proven ability to interpret complex clinical and scientific data and communicate findings clearly and accurately to regulatory and scientific audiences.Strong project management, communication, organizational, and cross-functional collaboration skills, with the ability to manage multiple priorities and deadlines.Experience developing or improving medical writing templates, standards, and processes, with a commitment to quality, knowledge sharing, and continuous improvement.