MMS · 4 hours ago
Nonclinical Writer
United States
Full-time
Remote
Entry, Mid Level
2+ years expMMS is an award-winning, data-focused clinical research organization (CRO) known for its exceptional culture and industry-leading employee retention. The Nonclinical Writer will be responsible for developing, writing, and managing highly technical nonclinical documents, ensuring alignment with regulatory guidelines and scientific integrity while collaborating with cross-functional teams.
BiotechnologyHealth CareLife Science
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)
Qualification
Required
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
Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process
Preferred
Hands-on experience with clinical trial and pharmaceutical development
Company
MMS
MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
501-1000 employees
H1B Sponsorship
MMS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (2)
2022 (8)
2021 (9)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Lindsay Goldberg
2022-06-28Private Equity
Leadership Team
Christopher Schoonmaker
Chief Operating Officer
Kevin Chartier
Principal Advisor, Biostatistics and Submission Planning
Recent News
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