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For Companies At a Glance
- Tasks: Lead the creation of high-quality regulatory and clinical documents in a dynamic team.
- Company: Join ICON plc, a world leader in healthcare intelligence and clinical research.
- Benefits: Enjoy competitive salary, health insurance, flexible benefits, and work-life balance.
- Why this job: Make a real impact in clinical development while working with diverse teams.
- Qualifications: Advanced degree in life sciences and 5+ years of medical writing experience required.
- Other info: ICON values inclusion and offers excellent career growth opportunities.
The predicted salary is between 36000 - 60000 £ per year.
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. We are currently seeking a Principal Medical Writer to join our diverse and dynamic team.
As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents to effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients’ submissions to regulatory authorities and ensuring compliance with industry standards. This role can be filled at Senior or Principal Medical Writer level.
What You Will Be Doing
- Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity.
- Performing medical writing tasks, especially those of high complexity and critical to project(s) and strategic area:
- Clinical trial reports (CTRs)
- Lay summaries of clinical trial results
- Investigator brochures (IBs)
- Clinical evaluation plans (CEP) and Clinical evaluation reports (CER)
- Paediatric investigational plans (PIPs)
- Clinical summary and overview documents in CTD/eCTD format for regulatory submissions worldwide (including investigational medicinal product dossiers (IMPDs), new drug applications (INDs), marketing authorisation applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs), and replies to questions from authorities)
- Protocol, protocol outlines and SI/IC
Your Profile
- Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred.
- Minimum 5 years of experience as a regulatory medical writer.
- Significant experience particularly in regulatory submissions and clinical documentation.
- Strong understanding of regulatory requirements and industry standards for clinical writing.
- Exceptional writing and editing skills, with a keen eye for detail and clarity.
- Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders.
- A commitment to maintaining high standards of quality and compliance in all medical writing activities.
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.
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here. 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.
Principal Medical Writer employer: ICON Strategic Solutions
Contact Detail:
ICON Strategic Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Medical Writer
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical writing field and let them know you're on the hunt for a Principal Medical Writer role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory requirements and industry standards. Be ready to discuss your experience with clinical documentation and how you've tackled complex writing tasks in the past. Confidence is key!
✨Tip Number 3
Showcase your writing skills! Bring samples of your previous work to interviews, especially those that highlight your ability to create clear and concise regulatory documents. This will give potential employers a taste of what you can bring to their team.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're genuinely interested in joining ICON and being part of our mission to shape the future of clinical development.
We think you need these skills to ace Principal Medical Writer
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Principal Medical Writer role. Highlight your relevant experience in regulatory submissions and clinical documentation, as this will show us you understand what we're looking for.
Showcase Your Writing Skills: Since this role is all about high-quality medical writing, include samples of your work if possible. We want to see your exceptional writing and editing skills in action, so don’t hold back!
Be Clear and Concise: When filling out your application, clarity is key. Use straightforward language and avoid jargon where possible. This will demonstrate your ability to communicate complex information effectively, which is crucial for the role.
Apply Through Our Website: We encourage you to apply directly through our careers site. It’s the best way to ensure your application gets into the right hands and helps us keep track of all applicants efficiently.
How to prepare for a job interview at ICON Strategic Solutions
✨Know Your Documents Inside Out
As a Principal Medical Writer, you'll be dealing with complex regulatory documents. Make sure you thoroughly understand the types of documents you'll be working on, like clinical study reports and investigator brochures. Familiarise yourself with their structure and key components so you can discuss them confidently during the interview.
✨Showcase Your Collaboration Skills
This role involves working closely with cross-functional teams. Be prepared to share examples of how you've successfully collaborated with clinical research, biostatistics, or regulatory affairs teams in the past. Highlight your communication skills and how they helped achieve project goals.
✨Demonstrate Your Attention to Detail
Attention to detail is crucial in medical writing. Bring along samples of your previous work that showcase your ability to produce high-quality, accurate documents. Discuss any specific strategies you use to ensure clarity and compliance with regulatory standards.
✨Stay Updated on Industry Standards
Regulatory requirements are constantly evolving. Show your commitment to staying informed by discussing recent changes in regulations or guidelines that impact medical writing. This will demonstrate your proactive approach and dedication to maintaining high standards in your work.
