What are the responsibilities and job description for the PRA International is hiring: Job Title Principal Medical Writer in Location position at PRA International?
Overview
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing :
- Prepare, write, edit, and review high-quality, clearly-messaged documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities.
- Serve as the RSW representative on project teams with the GRPT members and functional area contributors (e.g., Clinical, Pharmacovigilance, CPPM, etc.) when necessary.
- Participate in project management for compound programs and / or RSW projects and initiatives.
- Ensure accurate and timely completion / delivery of information and review of regulatory submissions.
- Communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members.
- Understand, assimilate, and interpret sources of information (e.g., scientific literature, internal and external studies) with appropriate guidance from GRPT team and / or authors / key opinion leaders.
- Ensure required documentation is obtained and confirm quality and completeness of information to be presented.
- Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents.
- Assist in regular communication with RSW leadership on timeline / milestone progress for any assigned program.
- Understand / comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies.
- Assist in the design and implementation of tactical process improvements.
Qualifications
You are :
What ICON can offer you : Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family. Examples of our benefits include :
Visit our careers website to read more about the benefits of working at ICON.
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