PRAHS

Senior Medical Writer

Posted Date 1 week ago(4/24/2024 11:33 AM)
ID
2024-110004
Location : Location
US-Remote

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Responsibilities

What you will be doing:

  • Independently produces clinical and regulatory documents in collaboration with Principal Medical Writers . These documents may include clinical study level documents such as Clinical Study Protocols or Clinical Study Reports. This includes Phase 1 in patients to Phase 3 across multiple therapeutic areas.
  • Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies.
  • Acts as the primary contact for the study team in relation to the preparation and timelines (incl. planning) of assigned documents.
  • Facilitates the review of the documents and ensures that documents are submission-ready and finally approved. When preparing documents you will be directly in contact with QC personnel and publishing specialists who support you in document preparation.

Qualifications

You are:

 

Minimum requirement of a bachelor’s degree; Master's degree preferred
3-5 years Medical Writing experience or other relevant pharmaceutical experience combined with scientific and regulatory knowledge
Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured messages.
Proficient in independently writing several types of clinical/regulatory documents (mainly CSRs, Protocols) including leading creation, coordination of the authoring functions, facilitation of the review of the documents and ensuring that documents are submission-ready and finally approved.

#LI-Remote


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.

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