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, marketing literature, regulatory applications, 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, regulatory        submissions, 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

· Perform other duties as assigned

Skills

· Commitment to the highest standards of ethics and integrity in all aspects of research, writing, and compliance

· Excellent verbal and written communication skills for effective collaboration and complex scientific discussions

· Strong technical and scientific writing abilities with a strong focus on clarity, accuracy, and compliance

· Strong organizational skills with the ability to prioritize, multitask, and meet tight deadlines in a fast-paced environment

· Proficiency in academic databases and search engines for conducting comprehensive literature reviews

· Ability to interpret, summarize, and present scientific data clearly and accurately in reports, white papers, and publications

· Excellent attention to detail and organization

· Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and statistical software

Qualifications/Requirements

· Master’s degree in Biomedical Sciences, Biology, Bioengineering, or related field, from an accredited college or university required

· Doctoral degree in a related field is preferred

· At least 5 years of experience in drafting, reviewing, and managing scientific documents, including protocols, regulatory submissions, and peer-reviewed manuscripts

· Proven track record of co-authorship in peer-reviewed manuscripts, demonstrating strong scientific writing skills

· Demonstrated success in contributing to competitive research proposals with a history of securing funding preferred

· Bachelor’s degree with 8 years of scientific writing experience in industry may be substituted to meet Master’s degree requirement

· Clearance of favorable background investigation required