Job Description
Salary:
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
Masters 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
Bachelors degree with 8 years of scientific writing experience in industry may be substituted to meet Masters degree requirement
Clearance of favorable background investigation required
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