Medical Writer II at Syneos Health
About Syneos Health: Syneos Health is a leading integrated biopharmaceutical solutions organization focused on accelerating customer success. By providing comprehensive clinical, medical affairs, and commercial insights, the company aims to address the complexities of the modern healthcare landscape. With 29,000 employees across 110 countries, Syneos Health is committed to simplifying clinical development and making a positive impact on patient lives through innovation.
Job Responsibilities:
Writing and Document Preparation:
Compile, write, and edit a variety of medical writing deliverables, including:
Clinical study protocols and amendments
Clinical study reports
Patient narratives
Annual reports
Investigator brochures
Review and ensure the quality of statistical analysis plans and specifications for tables, figures, and listings.
Cross-Department Collaboration:
Interact with teams from data management, biostatistics, regulatory affairs, and medical affairs to produce accurate and comprehensive documents.
Serve as a peer reviewer to ensure scientific content, clarity, and consistency in documents.
Adherence to Standards:
Ensure compliance with regulatory standards, including ICH-E3 guidelines, client standards, and company SOPs.
Conduct online clinical literature searches as needed to support writing tasks.
Mentorship and Leadership:
Mentor less experienced medical writers and support their development on projects.
Manage project timelines, stay within budget, and communicate changes or updates to medical writing leadership.
Continuous Professional Development:
Stay informed about changes in regulatory guidelines, client expectations, and medical writing standards to ensure work is current and relevant.
Additional Responsibilities:
Complete administrative tasks within specified timeframes.
Minimal travel (less than 25%) may be required.
Qualifications:
Education:
Bachelor of Science degree with relevant writing experience, or Bachelor of Arts degree (preferred in Social Sciences, English, or Communications) with scientific and/or medical expertise.
Experience and Skills:
Extensive knowledge of English grammar, FDA and ICH regulations, and AMA style guidelines.
High degree of independence, strong interpersonal skills, and leadership abilities.
Proficiency in Word, Excel, PowerPoint, email, and internet tools.
Ability to interpret and present clinical data and other complex information.
Why Syneos Health?
Career Development:
Syneos Health is committed to the continuous professional growth of its employees through training, mentorship, and recognition.
Inclusive Culture:
The company fosters a “Total Self” culture where employees are encouraged to bring their authentic selves to work, promoting diversity and inclusion.
Global Impact:
Syneos Health has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, contributing significantly to the global healthcare industry.
Additional Information:
Syneos Health may adjust job duties or responsibilities at their discretion and will consider equivalent experience, skills, and education. The company is also committed to compliance with the Americans with Disabilities Act and offers accommodations as necessary.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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