13 дней назад
Senior Nonclinical Writer
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Nonclinical Writer (Regulatory Medical Writing): Developing and managing highly technical nonclinical documents for IND, CTA, NDA, BLA, and MAA submissions with an accent on regulatory compliance, scientific integrity, and analysis of pharmacology, toxicology, and pharmacokinetic data. Focus on independently leading complex submission projects, mapping studies to eCTD Modules 2.4 and 2.6, and coordinating cross-functional regulatory writing activities.
Location: Remote within Canada; Toronto, ON, Canada
Company
is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical research, regulatory submissions, and scientific data expertise.
What you will do
- Develop, write, and manage technical nonclinical documents, including eCTD Modules 2.4 and 2.6, Investigator’s Brochures, nonclinical study reports, meeting requests, briefing documents, and RTQs.
- Lead nonclinical submission writing for INDs, CTAs, NDAs, BLAs, and MAAs with minimal oversight.
- Analyze pharmacokinetic, pharmacology, toxicology, bioanalytical, clinical pathology, and PK/TK data from technical source documents.
- Create mapping plans for placing nonclinical studies within eCTD Modules 2.4 and 2.6.
- Collaborate with project management, safety, efficacy, biostatistics, regulatory operations, and CMC teams.
- Lead contributors, client meetings, and complex projects while ensuring compliance with sponsor processes and regulatory guidelines.
Requirements
- Bachelor’s degree or higher in pharmacology, toxicology, biology, chemistry, or a related field.
- 5+ years of pharmaceutical regulatory nonclinical writing experience.
- Knowledge of GLP, ICH guidelines, and applicable regulatory requirements, including FDA and EMA guidance.
- Strong scientific writing, analytical, communication, time-management, and project-management skills.
- Proficiency with Microsoft Office and experience using systems such as SharePoint, Veeva RIM, PleaseReview, and EndNote.
- Understanding of CRO operations, nonclinical data and terminology, and the drug development process.
Nice to have
- Hands-on experience with clinical trials and pharmaceutical development.
- Experience with regulatory affairs, laboratory sciences, or quality assurance and control.
Culture & Benefits
- Full-time remote work within Canada.
- Collaborative and inclusive work environment.
- Opportunity to support pharmaceutical, biotech, and medical device research across a global organization.
- Regular team and client meetings with cross-functional collaboration.
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