Job description
Provide subject matter expertise to the Preclinical Research team by creating, enhancing, and updating Protocols, Evaluations, Service Studies, Final Reports, and Manuscripts for publication in accordance with quality policies and procedures.
Responsibilities
- Collaborate with Preclinical Project Leads, Study Directors, and Research Assistants to 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 and confirm the completeness of information, challenging conclusions when necessary.
- Provide communication regarding data and deliverables needed, the writing process, and timelines to the team.
- Oversee the management of documents through various stages and review steps, including Quality Assurance.
- Summarize study goals, design, methods, results, and conclusions, ensuring 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 of existing regulations, requirements, and standards, including but not limited to global regulatory requirements (ISO, FDA, etc.) and compliance requirements (GLP, USDA, AAALAC, departmental SOPs, 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).
Essential Skills
- Technical writing and Medical Technology knowledge.
- Experience with GLP.
- Strong experience in medical terminology.
- 3 to 5 years of experience with scientific protocols and final reports.
- Experience with 21 CFR part 58 is preferred.
- Established experience in Microsoft tools (Word, Excel, Pdf).
Additional Skills & Qualifications
- Bachelor’s Degree preferred.
- Preclinical Research or Clinical Research experience is preferred.
Work Environment
Hybrid work environment with onsite presence required on Tuesday, Wednesday, and Thursday.
Pay and Benefits
The pay range for this position is $30.00 - $33.50/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Cincinnati, OH.
Application Deadline
This position is anticipated to close on Jul 18, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
