Nonclinical Writer

MMS; Toledo (OH); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading clinical research organization is seeking a Nonclinical Writer to develop and write regulatory documents. The role involves collaborating with cross-functional teams and ensuring compliance with regulatory guidelines. Ideal candidates must have a BS+ in a related field and 2+ years of nonclinical writing experience. Strong writing skills and familiarity with GLP and ICH guidelines are essential for this remote position.

Qualifications

• 2+ years of pharmaceutical regulatory nonclinical writing experience.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Basic understanding of CROs and scientific & nonclinical data/terminology.

Responsibilities

• Lead projects independently with minimal oversight.
• Collaborate with cross-functional teams.
• Complete documents according to sponsor’s format and guidelines.

Skills

Strong writing and analytical skills

Knowledge of GLP, ICH guidelines

Proficiency with MS Office applications

Education

BS+ in pharmacology, toxicology, biology or chemistry

Tools

SharePoint

Veeva RIM

EndNote

Job description

Join to apply for the Nonclinical Writer role at MMS.

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). With a global footprint across four continents, MMS maintains an industry‑leading customer satisfaction rating and fosters a collaborative and inclusive work environment where employees can thrive. This is a full‑time, remote position.

Roles and Responsibilities

• Strong experience with development and writing of nonclinical documents (e.g., Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs)
• Lead projects independently with minimal oversight, leading the writing (structure, content and messaging) of nonclinical documents, ensuring the nonclinical package aligns with current regulatory guidelines and meets scientific integrity
• Author based on highly technical sources such as GLP and non‑GLP nonclinical study reports, in vivo and in vitro nonclinical data
• Develop a mapping plan for the placement of nonclinical studies within the structure of Module 2.4 and 2.6 eCTD submission documents
• Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (e.g., Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports)
• Collaborate with cross‑functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC
• Demonstrated ability to lead others to complete complex projects
• Complete documents according to sponsor’s format, processes, and regulatory guidelines
• Operate effectively in an environment requiring negotiation, persuasion, collaboration, and analytical judgment
• Serve as an organizational expert within the nonclinical subject area
• Exhibit excellent written and oral communication and strong time and project management skills
• Attend regular team meetings, lead client meetings and CRMs
• Work in various client systems (e.g., SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars
• Have a strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (e.g., ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)

Requirements

• BS+ in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements
• 2+ years of pharmaceutical regulatory nonclinical writing experience
• Strong writing and analytical skills
• Proficiency with MS Office applications
• Hands‑on experience with clinical trial and pharmaceutical development preferred
• Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process