As a Senior Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What You Will Be Doing
- Services rendered will adhere to applicable SOPs, WIs, policies, local
regulatory requirements, etc.
- Writes clear and concise clinical submission documents, including clinical study reports,
protocols, clinical overviews, investigator brochures, and summary documents; experience with late
stage health authority responses is a plus.
- Contributes to project plan concerning timelines as well as organization and table layout for a
specific document.
- Ensures that documents meet regulations, and the key messages as defined by the team are clearly
and adequately represented.
- Review and edit documents for consistency, progression, structure, and grammar.
- Review statistical analysis plans and incorporate into clinical study reports or submission
documents, as applicable.
- Drive the document preparation process, manage timelines, receive, and review primary
statistical output, draft, and distribute document for review, compile comments and edits, lead
comment resolution meetings independently.
- Participate in team and client meetings as requested.
You Are
- At least 5 years of pharmaceutical medical writing experience inclusive of clinical study
documents and global clinical regulatory submissions.
- 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 writing skills.
- Excellent interpersonal and oral communication skills.
- Strong knowledge of MS Word and Outlook, some knowledge of Excel and PowerPoint.
- Project management and organizational skills required including ability to manage timelines and
prioritize multiple projects.
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.