Medical Writer Lead
hace 3 semanas
As a key member of our team, you will be responsible for leading the development of high-quality clinical submission documents. Your expertise in medical writing will be instrumental in driving the content strategy for assigned drug projects.
Key Responsibilities:
- Develop and implement content strategies for clinical submission documents
- Lead the planning, development, and implementation of clinical submission documents
- Collaborate with cross-functional teams to develop and implement authoring resource plans
- Maintain current knowledge on regulatory agency medical review guidelines and drug approval requirements
- Develop regulatory submission content strategy and lead cross-functional writing teams
Requirements:
- 5-6 years of experience in regulatory medical writing, with 4 years in writing submission documents
- Master's degree in natural sciences, or Bachelor's degree with strong candidates also considered
- Thorough understanding of the overall drug development process
- Specific knowledge of clinical study report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions
Why ICON?
We offer a comprehensive and competitive total reward package, including excellent base pay, 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.
We are committed to developing our employees in a continuous learning culture, where every experience adds to your professional development. ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment.
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