Jacksonville, FL - Technical Writer - Scientific

JOB DESCRIPTION

Basic Function:

• Researches, writes and edits (pre)clinical reports, regulatory submissions, scientific publications, and/or technical business submissions
• This position is also responsible for summarizing data from (pre)clinical studies
• Develop cross-functional working relationships across internal Clinical, Regulatory and Pre-Clinical Development groups

Essential Duties:

• Summarize preclinical reports and summaries
• Write, edit regulatory compliance documents (i.e. Risk Management Reports in compliance with ISO 14971)
• Management of document reviews
• Support technical/clinical/regulatory writing for global regulatory submissions
• Quality control of documents for content, uniformity, adherence to ICH/FDA/EMEA or other appropriate regulatory guidelines
• Ensure compliance with company SOPs and style guidelines

Qualifications:

• Outstanding written and verbal communications skills are mandatory
• 5+ years of technical/medical/regulatory writing and relevant device/ pharmaceutical industry experience
• Related scientific and regulatory experience with knowledge of the technical medical writing process, required
• Bachelor’s degree or higher in a related scientific discipline
• Ability to work in a highly regulated environment with a strong attention to detail
• Self-motivation and flexibility are required
• Must be able to work effectively within a team setting (independently and collaboratively)
• Ability to troubleshoot document formatting and template design issues
• Expert on MS Office and commonly used PC applications
• Knowledge of:

• Understanding of current FDA regulations and guidelines, including but not limited to; ICH guidance documents, CTD, eCTD, IND, NDA, and CTA submissions
• Understanding of medical terminology within the device and/or pharmaceutical industry
• Knowledge of Risk Management principles a plus
• Advanced knowledge of and experience with MS Word

SUBMIT RESUME to Resume@ABOUT-Consulting.com
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