Job Title: Senior Medical Writer
Location: United States, Remote
About the Role:
As a Senior Medical Writer, you will be joining the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. This role provides an exciting opportunity to contribute to key regulatory submissions and response documents within a designated therapeutic or functional area.
What You Will Be Doing:
Leadership in Medical Writing:
Lead a team responsible for medical writing activities related to key response documents and regulatory submissions within a designated therapeutic or functional area.
Provide strategic guidance on writing, organization, content, timelines, and resource requirements.
Advanced Writing & Regulatory Submissions:
Contribute advanced input for study designs, analysis plans, and key sections of Investigational New Drug (IND) applications and marketing submissions.
Coordination & Management:
Manage deliverables and prepare documents for submission to regulatory agencies like the FDA, ensuring content consistency across therapeutic areas and compliance with regulatory standards.
Oversee the activities of contract employees and external vendors, ensuring proper review and editing of all contributions.
Collaboration & Guidance:
Represent the medical writing function on cross-functional teams, providing expertise and leadership to ensure smooth document preparation and production.
Lead efforts to resolve any issues that arise during document creation and submission.
Autonomous Work:
As a Senior Medical Writer, you are expected to be an expert in the field and perform your work independently, with minimal supervision.
You Are:
Qualifications:
Experience:
Knowledge and Skills:
What ICON Can Offer You:
Our success depends on the quality of our people, which is why we prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits designed to promote well-being and work-life balance:
Why ICON?
At ICON, diversity, inclusion, and belonging are at the heart of our culture and values. Our commitment to inclusivity drives our innovation and enhances our ability to serve our people, patients, customers, and communities. We are dedicated to providing an inclusive and accessible environment for all candidates, and ICON is committed to a discrimination-free workplace.
If you require a reasonable accommodation due to a medical condition or disability, please let us know.
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Canada |Quebec :
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Auckland |New Zealand :
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