Technical Writer Job at Kelly Science, Engineering, Technology & Telecom in Blue

Technical Writer
Kelly Outsourcing Consulting Group has an opening for a Technical Writer for a long-term engagement at one of our Global medical device clients in Cincinnati, Ohio.The role is eligible for medical benefits, paid time off including vacation (PTO), and holidays, 401K,and annual performance reviews. The Kelly COG team supports Preclinical Research in Vivarium operations and includes twenty team members.If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. This client is a company that’s leading the way in medical device industry.

• Schedule: On site – possible hybrid Monday through Friday day shift
  
• Pay: $33-36 an hour Depending on experience

PurposeProvide subject matter expertise to the Preclinical Research Team to create, enhance and update Protocols, Evaluations, Service Studies, Final reports and Manuscripts for publication in accordance with quality policies and procedures.
Responsibilities

• In collaboration with Preclinical Project Leads, Study Directors, and Research Assistants, develop and draft Protocols, Preclinical Evaluations, Service Memos, Final Reports and Manuscripts for publication.
  
• Convert relevant data and information into a format that meets preclinical regulatory document requirements.
  
• Develop charts, graphs, and data tables for inclusion in final reports. Confirm completeness of information and challenge conclusions when necessary.
  
• Provide communication regarding data and deliverables needed, writing process, and timelines to team.
  
• Oversee the management of documents through the various stages and review steps, including Quality Assurance.
  
• Summarize study goals, design, methods, results, and conclusions. Ensure that all supporting information is properly cited for easy retrieval.
  
• Review drafts with subject matter experts and revise as needed.
  
• Determine if current processes are compliant with company and surgical standards. Maintain current knowledge in existing regulations, requirements, and standards, including but not limited to global regulatory requirements (ISO, FDA, etc) and compliance requirements (GLP, USDA, AAALAC, departmental SOP’s, company policies, etc).
  
• Prepare drafts of preclinical summary documents from detailed reports.
  
• Comply with Standard Operating Procedures to ensure compliance with FDA Good Laboratory Practices (21 CFR, Part 58).

• Qualifications
  
• Bachelor’s Degree preferred
  
• A strong background in medical terminology required
  
• 3 to 5 years’ experience with scientific protocols and final reports
  
• Experience with 21 CFR part 58 is preferred
  
• Established experience in Microsoft tools (Word, Excel, Pdf)
  
• Preclinical Research or Clinical Research experience is preferred

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