R&D Scientific Writer

Purpose

The R&D Scientific Writer is responsible for creating and managing high-quality scientific documentation across all stages of research and development, including protocols, procedures, manuscripts, literature reviews, research proposals and patent applications. This role ensures compliance with regulatory standards and collaborating with cross-functional teams to support organizational objectives and effectively communicate scientific advancements.

Responsibilities

• Draft, edit, and finalize a wide range of scientific documents, including research proposals, protocols, reports, manuscripts, and patent applications
• Conduct comprehensive literature searches and reviews to gather, analyze, and summarize relevant scientific data for ongoing and future R&D initiatives
• Manage multiple writing projects ensuring quality standards and timely completion
• Collaborate with research teams to interpret data and accurately represent study outcomes in written materials
• Develop, revise, and maintain clear, detailed research protocols, SOPs, and regulatory documentation in compliance with industry and organizational standards
• Identify opportunities for publications, collaborations, and dissemination of research findings to enhance scientific visibility
• Draft manuscripts for peer-reviewed journals, incorporating relevant data and effectively addressing reviewer feedback
• Manage documentation processes including revisions, approvals, and version control to ensure compliance
• Ensure all scientific documentation meets regulatory requirements
• Create white papers, brochures, and technical content to communicate research findings and product innovations
• Support research proposals by integrating scientific rationale, budgets, and strategic goals
• Work cross-functionally with Quality, Marketing, Regulatory Affairs, and Product Development teams to ensure scientific accuracy and alignment
• Develop best practices, templates, and style guides to standardize scientific writing across the organization
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP / CGTP, other relevant regulations / standards, and internal organizational policies and standard operating procedures
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes
• Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business / operational needs when necessary

Skills

Qualifications / Requirements

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