Principal Medical Writer
- United States
- Medical Writing
- ICON Strategic Solutions
- Remote
TA Business Specialist
- Icon Strategic Solutions
About the role
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
- Manages all aspects of the medical writing function.
- Writes and reviews clinical study reports, protocols, and other clinical/regulatory documents.
- Contributes to clinical protocol development for first-in-human oncology studies.
- Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.).
- Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents
- Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers.
- Acts as a lead medical writer on complex programs and numerous individual studies.
- Provides
You are:
- Advanced degree in a relevant scientific/clinical/regulatory field preferred
- At least 5 years of experience in a lead medical writing role in the pharmaceutical/CRO industry. *Note: Immunology experience is preferred but not required.
- Excellent writing skills.
- Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
- Knowledge of current requirements and guidelines applicable to submission documents
- Excellent interpersonal and oral communication skills.
- Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
- Ability to prioritize multiple projects
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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