MMS
Join us as a Nonclinical Writer at MMS, a leading data‑focused clinical research organization. This full‑time, remote position involves the development, writing, and management of highly technical nonclinical documents.
Roles and Responsibilities
Strong experience with development and writing of nonclinical documents such as Module 2.4 and 2.6 eCTD submissions, Investigator’s Brochure (IB), Nonclinical Study Reports, Meeting Requests, Briefing Documents, and RTQs.
Lead projects independently with minimal oversight, writing the structure, content, and messaging of nonclinical documents, and ensuring alignment with regulatory guidelines and scientific integrity.
Author based on highly technical sources (GLP and non‑GLP study reports, in‑vivo and in‑vitro data).
Develop a mapping plan for placement of nonclinical studies within the structure of Module 2.4 and 2.6 eCTD 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, biostatistics, regulatory operations, and CMC.
Lead others to complete complex projects.
Complete documents according to sponsor format, processes, and regulatory guidelines.
Operate effectively in an environment requiring negotiation, persuasion, collaboration, and analytical judgment.
Organizational expert within the nonclinical subject area.
Excellent written and oral communication with 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).
Strong understanding of regulatory guidances applicable to nonclinical submission documents and drug development (ICH, FDA, EMA, GLP, GCP, GMP, GDP).
Requirements
BS+ in pharmacology, toxicology, biology, chemistry, or related field, with industry experience in regulatory writing, regulatory affairs, laboratory sciences, or 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 terminology and the drug development process.
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Roles and Responsibilities
Strong experience with development and writing of nonclinical documents such as Module 2.4 and 2.6 eCTD submissions, Investigator’s Brochure (IB), Nonclinical Study Reports, Meeting Requests, Briefing Documents, and RTQs.
Lead projects independently with minimal oversight, writing the structure, content, and messaging of nonclinical documents, and ensuring alignment with regulatory guidelines and scientific integrity.
Author based on highly technical sources (GLP and non‑GLP study reports, in‑vivo and in‑vitro data).
Develop a mapping plan for placement of nonclinical studies within the structure of Module 2.4 and 2.6 eCTD 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, biostatistics, regulatory operations, and CMC.
Lead others to complete complex projects.
Complete documents according to sponsor format, processes, and regulatory guidelines.
Operate effectively in an environment requiring negotiation, persuasion, collaboration, and analytical judgment.
Organizational expert within the nonclinical subject area.
Excellent written and oral communication with 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).
Strong understanding of regulatory guidances applicable to nonclinical submission documents and drug development (ICH, FDA, EMA, GLP, GCP, GMP, GDP).
Requirements
BS+ in pharmacology, toxicology, biology, chemistry, or related field, with industry experience in regulatory writing, regulatory affairs, laboratory sciences, or 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 terminology and the drug development process.
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