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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 top healthcare intelligence and clinical research organisation.
- Benefits: Enjoy competitive salary, health insurance, flexible benefits, and work-life balance.
- Why this job: Make a real impact in clinical development while advancing your career.
- Qualifications: Advanced degree in life sciences and 5+ years of medical writing experience required.
- Other info: Inclusive culture with opportunities for continuous learning and career growth.
The predicted salary is between 36000 - 60000 ÂŁ 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 that 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. As a Principal Medical Writer you will be fully dedicated to a Top-5 pharmaceutical company. While working for our client, you will be able to profit from ICON through continued learning opportunities and building a longer‑term career.
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 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.
- Collaborating with cross‑functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development.
- Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards.
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 in medical writing, 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.
Benefits Examples
- 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 specialists 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 in Reading employer: ICON
Contact Detail:
ICON Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Medical Writer in Reading
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical writing field on LinkedIn or at industry events. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Show off your expertise! Prepare a portfolio of your best work, especially those regulatory documents you've crafted. When you get the chance to chat with recruiters or hiring managers, having tangible examples can really set you apart.
✨Tip Number 3
Practice makes perfect! Get comfortable with common interview questions for medical writers. Think about how your experience aligns with the role at ICON and be ready to discuss specific projects you've led.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you're genuinely interested in joining our diverse team at ICON.
We think you need these skills to ace Principal Medical Writer in Reading
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 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, keep it clear and to the point. We appreciate clarity and detail, so make sure your application reflects that. Avoid jargon unless it's relevant to the role.
Apply Through Our Website: We encourage you to apply directly through our careers site. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, you can check out all the benefits we offer while you're there!
How to prepare for a job interview at ICON
✨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 mentioned in the job description, like clinical study reports and investigator brochures. Familiarise yourself with their structure and purpose so you can discuss them confidently during the interview.
✨Showcase Your Collaboration Skills
This role involves working with cross-functional teams, so be prepared to share examples of how you've successfully collaborated with others in the past. Highlight your communication skills and how you've navigated challenges in team settings, as this will demonstrate your ability to fit into their diverse environment.
✨Stay Updated on Regulatory Standards
Regulatory requirements are constantly evolving, so it's crucial to stay informed. Before your interview, brush up on the latest guidelines relevant to medical writing and be ready to discuss how you ensure compliance in your work. This shows your commitment to quality and adherence to industry standards.
✨Prepare Thoughtful Questions
Interviews are a two-way street, so come prepared with insightful questions about the role and the company culture. Ask about their approach to professional development or how they foster an inclusive environment. This not only shows your interest but also helps you gauge if ICON is the right fit for you.
