Nonclinical Writer
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn . This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities:
- Strong experience with development and writing of nonclinical documents (eg, 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, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity
- Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data
- Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents
- Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, 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
- Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines
- Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
- Organizational expert within the nonclinical subject area
- Excellent written/oral communication and strong time and project management skills
- Ability to attend regular team meetings, lead client meeting and CRMs
- Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars
- Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)
- 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
Recommended Jobs
Regional Strategic Sales Manager
Position Overview The Regional Strategic Sales Manager is responsible for executing Fujifilm's regional dealer sales strategy across an assigned geographic territory, driving sell-in and sell-thro…
Account Executive / Ann Arbor
Make your mark for patients To strengthen and support our launches within US Rare Disease Organization (RDO), we are seeking an Account Executive - Neuromuscular (AE) for the Ann Arbor, Michigan…
Accounting Manager
Church Extension Fund, a ministry-based financial institution located in Ann Arbor, Michigan, seeks qualified candidates for the position of Accounting Manager. The position is responsible for a vari…
Engineering Manager (Operations)
Engineering Manager- Operations ANDRITZ BCN Technical Services, Inc Engineering Manager- Operations Position Overview: ANDRITZ BCN is a leader in the metal forming industry, known for…
Crisis Social Worker
Location: Monroe, MI 48161 Date Posted: 12/30/2025 Category: Behavioral Education: Master’s Degree Delta-T Group connects professionals with client opportunities within the special educatio…
Patient Services Associate - Full-Time
Join Our Team as a Patient Services Associate! Location: Saginaw, MI Full-Time Are you a reliable, detail-oriented professional with a passion for helping others? Do you want to work in a suppo…
Evaluations Manager - Experiential Marketing
**must be able to work hybrid in the Detroit office 3 days/week** We're looking for a strategic Evaluations Manager to lead valuation projects, manage client relationships, and develop impactful s…
Branch Operations Lead - Detroit Main - Detroit, MI
Job Description At Chase, we are passionate about creating memorable experiences for our clients and employees, making them feel welcomed, valued, and understood. We build lasting relationships by …
CDL A Trainees Regional
Start Your Career with 18 Wheels USA : New Trucks, Paid Training, & Eastern Seaboard Lanes. Are you a recent CDL graduate looking for a company that actually invests in your future? 18 Wheels USA…