Medical Writer Expert
hace 4 semanas
Key Responsibilities:
As a Principal Medical Writer, you will be responsible for leading the planning, development, and implementation of the content strategy of clinical submission documents. This includes driving the design of clinical submission documents in support of the Clinical Development Plan, validating individual study protocol design, key messages of the clinical study report, and other clinical submission documents.
Key Skills:
You will need to have a thorough understanding of the overall drug development process, including clinical study report development, regulatory and drug safety requirements, and clinical data management and statistical processes/functions. Experience in developing clinical documents in support of regulatory submissions globally is also required.
Why ICON?
We offer a comprehensive and competitive total reward package, including a wide range of variable pay and recognition programs. Our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career.
Requirements:
- 5-6 years experience in regulatory medical writing, with 4 years in writing submission documents
- Master's degree in natural sciences, or strong candidates with a Bachelor degree will also be reviewed
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