03 oct
|
Icon Clinical Research
|
México
03 oct
Icon Clinical Research
México
Principal Medical Writer
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s general expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
We are currently seeking Senior or Principal Medical Writer to join our diverse and dynamic team. At this role you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients’ submissions to regulatory authorities and ensuring compliance with industry standards.
We hire at Medical Writer 2, Senior Medical Writer or Principal Medical Writer level
What You Will Be Doing:Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing of documents. As necessary,
may assume primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submission. Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area. Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation, including international regulatory guidance and requirements for content and format, work requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
- Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
- Provides more complex advanced input for study des
📌 Senior Medical Writer (México)
🏢 Icon Clinical Research
📍 México