Us To Help Unite Science Technology
Healthcare
PrincipalMedicalWriter
“Principal Medical Writer at Us To Help Unite Science Technology. Skills: Clinical regulatory writing, Regulatory submissions, Data interpretation. Write clinical and regulatory documents. Work in matrix teams”
Industry & Context.
Practical problem solving; Problem solving
What They're Looking For.
Must Have
5 years clinical regulatory writing experience, PhD or equivalent expertise, Master's degree with relevant experience, Working knowledge of ICH/GCP, Necessary computer skills, General computer literacy, Excellent English language skills
Nice to Have
PhD or equivalent expertise
What You'll Do.
Write clinical and regulatory documents
Deliver fit-for-purpose documents
Meet regulatory standards
Plan clinical dossiers
Produce clinical dossiers
Assess complex situations
Implement scientific solutions
Implement operational solutions
Implement submission solutions
Interpret complex clinical data
Synthesize trends in text
Synthesize trends in statistics
Organize content in reports
Organize messaging in summaries
Review analysis plans
Review reporting plans
Advise on table content
Speed document preparation
Mentor junior writers
Adapt to changing priorities
Adapt to changing therapeutic areas
Communicate in writing
How You'll Work.
Team & Collaboration
Matrix teams
Communication Scope
Oral communication; Written communication
Process & Methodology
Project management
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