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For Companies At a Glance
- Tasks: Write and edit clinical documents while collaborating with project teams.
- Company: Join ICON, the world's largest clinical research organisation focused on healthcare intelligence.
- Benefits: Enjoy flexible remote work, competitive salary, health insurance, and various well-being perks.
- Why this job: Make an impact in healthcare while working in a diverse and inclusive culture.
- Qualifications: Advanced degree preferred; 3+ years in medical writing; excellent writing and communication skills required.
- Other info: Remote work available across the UK and Europe; all qualified applicants encouraged to apply.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Join to apply for the Senior Medical Writer role at ICON Strategic Solutions.
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 Medical Writer to join our diverse and dynamic team. As a Senior 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.
Purpose
Deliver high quality relevant Clinical Pharmacology & Pharmacometrics (CPP) documents (e.g. population PK/PD data transfer plans, population PK/PD analysis plans and population PK/PD reports), as well as CSRs, protocols, and other documents, within the required regulatory system per global aligned procedures of the client.
Documents That The Writer Will Be Doing Include
- CSRs for phase 1 healthy volunteer trials and clinical pharmacology trials.
- Protocols for healthy volunteer studies.
- Module 2.7.1 and 2.7.2
Expectations
- Write clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents.
- Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers.
- Provide scientific and medical writing consultancy to project teams, as requested.
Deliverables
- Services rendered will adhere to applicable client’s SOPs, WIs, policies, local regulatory requirements, ICH‑GCP, etc.
- Clear communication with clinical pharmacology & pharmacometric leaders and other team members.
- Ensure deliverables are inspection ready and compliant with relevant requirements.
- Maintain the central planning of population PK/PD document writing and QC deliverables.
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 summarizing 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 prioritizing 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
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 Include
- 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.
Visit our careers site to read more about the benefits ICON offers.
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.
Interested in the role, but unsure if you meet all 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.
Are you a current ICON Employee? Please consider applying.
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Seniority level
- Mid‑Senior level
Employment type
- Full‑time
Job function
- Marketing, Public Relations, and Writing/Editing
Industries
- Pharmaceutical Manufacturing
Location: London, England, United Kingdom.
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Senior Medical Writer employer: ICON Strategic Solutions
Contact Detail:
ICON Strategic Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer
✨Tip Number 1
Familiarise yourself with the specific medical writing templates and software mentioned in the job description, such as PleaseReview and Documentum. Having hands-on experience or even a basic understanding of these tools can set you apart from other candidates.
✨Tip Number 2
Network with professionals in the clinical research field, especially those who work in regulatory medical writing. Attend industry conferences or webinars to connect with potential colleagues and learn more about the latest trends and requirements in medical writing.
✨Tip Number 3
Prepare to discuss your experience with clinical study reports and protocols during the interview. Be ready to provide examples of how you've contributed to document preparation processes and resolved feedback from reviewers in previous roles.
✨Tip Number 4
Showcase your ability to communicate complex scientific data clearly. During interviews, practice explaining technical concepts in simple terms, as this skill is crucial for the role and will demonstrate your suitability for the position.
We think you need these skills to ace Senior Medical Writer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical writing, particularly in regulatory documents. Emphasise your advanced degree and any specific skills related to clinical drug development.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about medical writing and how your background aligns with the role. Mention your familiarity with medical writing templates and software, as well as your ability to communicate complex data clearly.
Showcase Your Writing Skills: Include samples of your previous work that demonstrate your ability to write clear and concise scientific documents. If possible, provide examples of study reports or protocols you've authored or contributed to.
Highlight Interpersonal Skills: Since the role requires collaboration with project teams, mention any experiences where you've successfully worked in a team environment. Highlight your communication skills and ability to incorporate feedback from reviewers.
How to prepare for a job interview at ICON Strategic Solutions
✨Showcase Your Writing Skills
As a Senior Medical Writer, your writing skills are paramount. Bring samples of your previous work to the interview, such as clinical study reports or protocols, to demonstrate your ability to write clearly and concisely.
✨Understand the Regulatory Landscape
Familiarise yourself with current guidelines and requirements for submission documents. Be prepared to discuss how you have navigated these in your past roles, as this will show your expertise in regulatory medical writing.
✨Highlight Your Technical Proficiency
Make sure to mention your experience with medical writing software like PleaseReview and Documentum. Discuss how you've used these tools to enhance your writing process and improve document quality.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world scenarios. Think about challenges you've faced in document preparation and how you resolved them, as this will showcase your critical thinking and adaptability.
