About the Role
Senior Medical Writer
Join the world's largest and most comprehensive clinical research organization, driven by healthcare intelligence. In this role, you will be supporting a top-5 pharmaceutical company, helping them deliver best-in-class regulatory and submission documents. While employed by ICON, you will work directly with our client, fully embedded in their team.
Responsibilities
Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers. Documents may include clinical study-level documents such as Clinical Study Protocols or Clinical Study Reports, spanning Phase 1 to Phase 3 across multiple therapeutic areas.
Thoroughly analyze and interpret data to determine the best approach for composing each document, applying lean writing strategies.
Serve as the primary point of contact for the study team regarding the preparation and timelines (including planning) of assigned documents.
Facilitate the document review process, ensuring that documents are submission-ready and receive final approval. Work closely with QC personnel and publishing specialists to support document preparation.
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Your Profile
Education: Minimum of a Bachelor’s degree (Master’s degree preferred).
Experience: 3-5 years of Medical Writing experience or other relevant pharmaceutical experience, combined with scientific and regulatory knowledge.
Skills:
Strong writing skills with the ability to convert complex scientific data into clear, scientifically sound, and well-structured messages.
Proficient in independently writing clinical and regulatory documents, especially Clinical Study Reports (CSRs) and Protocols.
Experience in leading the creation and coordination of authoring functions, facilitating document reviews, and ensuring submission-ready documents are finalized and approved.
This role provides an excellent opportunity to make a meaningful impact in clinical research and regulatory submission processes while being part of a world-class team at ICON.
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Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | Temecula | Thousand Oaks | Vallejo | West Valley City | Whittier | Willits |Colorado :
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Bridgeport | Bristol | Enfield | Groton | Newtown | South Windsor | Storrs | West Hartford |D.C :
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Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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Prague |Republic of Egypt :
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Warsaw |Remote :
Remote - Europe | Remote, USA | Remote | Remote - Middle East | Switzerland |Bucharest :
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Rabigh | Najran | Jeddah | Khulais | Riyadh |Nišava District :
Niš |Singapore :
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Midrand |Brazil :
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Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
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Kyiv |Dubai :
Dubai |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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