Technical Writer

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

Purpose

Provide 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).

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

What happens next

Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry—even if this position doesn't work out, you're still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.

Helping you discover what's next in your career is what we're all about,

P1

9819232

J-18808-Ljbffr