AllSTEM Connections is hiring: Senior Medical Writing Manager in Plainsboro

AllSTEM Connections is seeking a Senior Medical Writing Manager to work onsite in Plainsboro, NJ.

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This is a seven-month contract position. Possible extension/temp-to-hire.

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Hourly rate is up to $105/hour.

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SUMMARY:

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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.

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RESPONSIBILITIES

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Clinical and Regulatory Document Development

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• Independently 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).
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• Prepare clinical overviews, summaries, and other clinical documentation in CTD/eCTD format to support regulatory submissions.
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• Draft and edit Health Authority briefing documents, briefing books, responses, and other regulatory submission materials.
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• Prepare and review scientific publications, including abstracts, posters, slide presentations, and manuscripts.
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• Interpret and communicate complex clinical and scientific data clearly, accurately, and consistently for regulatory and scientific audiences.
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Medical Writing Leadership and Project Management

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• Serve as compound lead writer and Medical Writing representative on cross-functional clinical development and regulatory teams.
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• Provide guidance on document strategy, content, timelines, and resource requirements to ensure high-quality, timely deliverables.
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• Lead or participate in regulatory submission activities, coordinating document planning, cross-functional reviews, reviewer comments, and resolution of document-related issues.
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• Manage document development from initial templates through review, approval, and finalization, including meeting coordination, review schedules, and decision tracking.
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Process Development and Continuous Improvement

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• Develop and maintain medical writing templates, standards, and processes.
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• Recommend and lead process improvement initiatives to enhance document quality, efficiency, and cross-functional and global collaboration.
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• Share best practices, lessons learned, and technical knowledge through departmental initiatives and interdepartmental knowledge-sharing activities.
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Regulatory Compliance and Quality

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• Maintain current knowledge of applicable regulatory guidelines, ICH guidelines, and global submission requirements.
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• Ensure clinical and regulatory documents comply with applicable guidelines, standard operating procedures (SOPs), internal practices, and technical standards.
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• Maintain relevant therapeutic-area and medical writing expertise.
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QUALIFICATIONS

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• Approximately 6–8+ years of medical writing experience within the pharmaceutical or biotechnology industry, including independent authorship and leadership of complex clinical and regulatory documents.
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• Demonstrated experience authoring and reviewing clinical trial protocols, investigator’s brochures, clinical study reports, clinical summaries or overviews, briefing documents, and Health Authority responses.
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• Strong understanding of clinical development, regulatory submission requirements, CTD/eCTD structure, ICH guidelines, and applicable global regulatory requirements.
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• Experience leading medical writing activities for regulatory submissions, including document planning, cross-functional reviews, timeline management, and resolution of complex reviewer comments.
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• Proven ability to interpret complex clinical and scientific data and communicate findings clearly and accurately to regulatory and scientific audiences.
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• Strong project management, communication, organizational, and cross-functional collaboration skills, with the ability to manage multiple priorities and deadlines.
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• Experience developing or improving medical writing templates, standards, and processes, with a commitment to quality, knowledge sharing, and continuous improvement.
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