At a Glance
- Tasks: Lead the creation of clinical documents and collaborate with diverse teams on innovative research.
- Company: Join ICON plc, a top healthcare intelligence and clinical research organisation.
- Benefits: Enjoy competitive salary, health insurance, flexible benefits, and a supportive work-life balance.
- Other info: Inclusive culture focused on innovation, excellence, and career growth opportunities.
- Why this job: Make a real impact in clinical development while mentoring future medical writers.
- Qualifications: Advanced degree in Life Sciences and 3-5 years of medical writing experience required.
The predicted salary is between 55000 - 65000 € 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 Senior or Principal Medical Writer to join our diverse and dynamic team. As a Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies.
What you will be doing:
- Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy, clarity, and compliance with regulatory guidelines and industry standards.
- Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, summarise scientific findings, and communicate key insights in written form.
- Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives.
- Contributing to the development of publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences, disseminating study results and scientific insights to the broader scientific community.
- Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles, and fostering a culture of excellence, collaboration, and continuous learning within the medical writing team.
Your profile:
- Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
- Proficiency in interpreting and summarising complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills, and the ability to communicate scientific concepts to diverse audiences.
- Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process.
- Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritising tasks based on project timelines and deliverables.
- Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes.
What ICON can offer you:
- 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.
At ICON, inclusion and 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, colour, 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.
Senior or Principal Medical Writer employer: IRE
At ICON plc, we pride ourselves on being a world-leading healthcare intelligence and clinical research organisation that champions innovation and excellence. Our inclusive work culture fosters collaboration and continuous learning, providing ample opportunities for professional growth and mentorship, particularly for roles like the Senior or Principal Medical Writer. With competitive benefits focused on well-being and work-life balance, along with a commitment to diversity, ICON is an exceptional employer for those looking to make a meaningful impact in clinical development.
StudySmarter Expert Advice🤫
We think this is how you could land Senior or Principal Medical Writer
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching ICON and understanding their mission and values. Tailor your responses to show how your experience aligns with their goals, especially in clinical research and medical writing.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. Focus on articulating your experience in leading medical writing projects and collaborating with cross-functional teams.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows your genuine interest in joining our diverse and dynamic team at ICON.
We think you need these skills to ace Senior or Principal Medical Writer
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Senior or Principal Medical Writer role. Highlight your relevant experience in medical writing and how it aligns with our mission at ICON.
Showcase Your Skills:Don’t forget to emphasise your writing, editing, and proofreading skills. We want to see how you can communicate complex scientific concepts clearly and effectively, so give us examples!
Be Specific About Your Experience:When detailing your past roles, focus on specific projects you've worked on, especially those involving clinical study documents. This will help us understand your expertise and how you can contribute to our team.
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 shows your enthusiasm for joining our diverse team at ICON.
How to prepare for a job interview at IRE
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical study documents and regulatory guidelines. Familiarise yourself with ICH-GCP, FDA, and EMA requirements, as well as the types of documents you'll be working on, like CSRs and IBs. This will show that you're not just a great writer but also understand the science behind it.
✨Showcase Your Collaboration Skills
Since this role involves working closely with cross-functional teams, be prepared to discuss your experience in collaborating with clinical research, biostatistics, and regulatory affairs. Share specific examples of how you've effectively communicated complex data and insights to diverse audiences.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills in a fast-paced environment. Think of situations where you had to manage multiple projects or tight deadlines. Be ready to explain how you prioritised tasks and ensured quality in your writing under pressure.
✨Mentorship Matters
As a Senior or Principal Medical Writer, you'll likely mentor junior writers. Be ready to discuss your approach to coaching and sharing best practices. Highlight any past experiences where you helped others improve their writing skills or fostered a collaborative team culture.
