Full-Time
Nonclinical Writer
Updated on 8/3/2026
MMS
1,001-5,000 employees
Regulatory compliance and data solutions provider
No salary listed
Canton, MI, USA
Remote
 Content & Writing (1) |
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- A Bachelor of Science degree or higher in pharmacology, toxicology, biology, chemistry, or a related field, with industry experience in regulatory writing, regulatory affairs, laboratory sciences, or quality assurance/control.
- Knowledge of Good Laboratory Practice, International Council for Harmonisation guidelines, and applicable regulatory requirements.
- At least 2 years of pharmaceutical regulatory nonclinical writing experience.
- Strong writing and analytical skills.
- Proficiency with Microsoft Office applications.
- Basic understanding of contract research organizations, scientific and nonclinical data and terminology, and the drug development process.
- Develop and write nonclinical documents, including Module 2.4 and 2.6 electronic Common Technical Document submission documents, Investigator’s Brochures, Nonclinical Study Reports, Meeting Requests, Briefing Documents, and Responses to Questions.
- Lead projects independently with minimal oversight and lead the writing, including structure, content, and messaging, of nonclinical documents while ensuring alignment with current regulatory guidelines and scientific integrity.
- Author documents based on highly technical sources such as Good Laboratory Practice and non-Good Laboratory Practice nonclinical study reports and in vivo and in vitro nonclinical data.
- Develop mapping plans for placement of nonclinical studies within the structure of Module 2.4 and 2.6 electronic Common Technical Document submission documents.
- Interpret and analyze pharmacokinetics, pharmacology, and toxicology data, including Prism files, bioanalytical reports, clinical pathology reports, and pharmacokinetic/toxicokinetic evaluation reports.
- Collaborate with project management, safety, efficacy, biostatistics, regulatory operations, and chemistry, manufacturing, and controls teams.
- Lead others to complete complex projects.
- Complete documents according to sponsor formats and processes and applicable regulatory guidelines.
- Operate in an environment requiring negotiation, persuasion, collaboration, and analytical judgment.
- Serve as an organizational expert within the nonclinical subject area.
- Manage written and oral communications and time and projects effectively.
- Attend regular team meetings and lead client meetings and clinical research meetings.
- Work in client systems, including SharePoint, Veeva RIM, PleaseReview, and EndNote, as well as client templates and toolbars.
- Apply regulatory guidance to nonclinical submission documents and drug development, including International Council for Harmonisation, Food and Drug Administration, European Medicines Agency, Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice, and Good Distribution Practice regulations and guidelines.
- Hands-on experience with clinical trial and pharmaceutical development is preferred.
MMS Holdings is a global contract research organization (CRO) focused on regulatory compliance and data-driven solutions for pharmaceutical and biotech sponsors. It delivers services such as regulatory submissions, clinical trial management, data analytics, and medical writing through a service-based model that relies on established processes and experienced advisors. Its work is contract-based, often long-term, aimed at helping clients meet regulatory requirements, run trials efficiently, and advance therapies under FDA guidance. The company differentiates itself with a science-first approach, a strong track record (97% client satisfaction), and involvement in complex areas like enabling MDMA-assisted therapy research, underscoring a commitment to high-quality, compliant outcomes for sponsors globally.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Canton, Ohio
Founded
2006
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Growth & Insights and Company News
6 month growth
↑ 20%1 year growth
↑ 20%2 year growth
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