At a Glance
- Tasks: Create and manage clinical documents while collaborating with a dynamic team.
- Company: Join Parexel, a global leader in clinical development and innovation.
- Benefits: Flexible work environment, growth opportunities, and a chance to impact patient care.
- Other info: Be part of a supportive team that values your contributions and ideas.
- Why this job: Make a difference in clinical research and contribute to life-changing therapies.
- Qualifications: 5 years of medical writing experience and a scientific degree required.
The predicted salary is between 40000 - 50000 £ per year.
About Parexel
Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry.
With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.
About Parexel
Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry.
With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies.
We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research.
We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.
About The Role
We are seeking an experienced Medical Writer to join a key functional service provider program supporting one of our key sponsors.
As a Medical Writer, you will act as an integrated resource within the team, delivering Medical Writing Services for the creation of clinical documents including CTRs, CTPs and amendments, IBs and updates, biomarker reports, and submission documents.
Working in a dedicated sponsor aligned environment, you will contribute to high quality clinical development programs through close collaboration, scientific communication, and proactive project engagement.
Key Responsibilities
- Document management within the EDMS.
- Review and approval of Statistical Analysis Plans in the EDMS.
- Management of timelines and ongoing schedule updates.
- Preparation for and attendance at trial team and submission meetings.
- Preparation, conduct, and documentation of kick off meetings.
- Preparation, conduct, and documentation of Results Alignment Meetings where applicable.
- Writing of drafts including tables and figures according to agreed timelines.
- Management of review cycles, comment reconciliation, and review documentation.
- Initiation, monitoring, or conduct of Quality Control reviews and associated documentation.
- Creation and provision of final document versions to project teams.
- Publishing support, pre archive checks, and resolution of findings.
- Electronic approval of final clinical documents in the EDMS.
- Technical and formatting checks for IBs and updates.
- Compliance with sponsor processes and SOPs.
- Participation in governance, feedback, and alignment meetings.
- You Will Thrive In This Role If You Bring
- Previous Medical Writer or Senior Medical Writer experience.
- Strong collaboration and communication skills.
- Excellent attention to detail and document quality focus.
- A patient focused mindset and commitment to advancing clinical research.
- Required Qualifications
- Scientific degree and/or advanced scientific degree.
- 5 years’ experience within medical writing.
- Knowledge of ICH GCP, regulatory requirements, and clinical trial processes.
- Experience with clinical document management systems and related tools.
- Strong communication, organization, and problem solving skills.
We believe in flexibility, growth, and creating space for people to do their best work.
Join us and be part of a team where your contributions help shape the future of clinical research.
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Senior Medical Writer - UK or Ireland - FSP in Uxbridge employer: Parexel
At Parexel FSP, we pride ourselves on being an exceptional employer, offering a dynamic and supportive work environment for our IRT Vendor Start-up Manager role. With a focus on employee growth and development, we provide comprehensive training and opportunities to collaborate with industry experts, all while enjoying the flexibility of a home-based position in the UK or Ireland. Our commitment to excellence and innovation ensures that you will be part of a team that values your contributions and fosters a culture of success.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Medical Writer - UK or Ireland - FSP in Uxbridge
✨Get Involved with Local Health Initiatives
Join local community health events or volunteer for organisations like public health agencies. This not only builds your experience but also helps you network with industry professionals who might know of openings at places like Parexel.
✨Tap into Professional Associations
Check out associations like the Institute of Healthcare Management. They often have job boards, networking events, and conferences that are perfect for connecting with potential employers in health sciences administration.
✨Stay Updated with Industry Trends
Follow health policy news and trends—being knowledgeable about the current landscape will not only help you in interviews but also make you stand out as a candidate. You can discuss recent developments and their implications when chatting with folks at Parexel.
✨Apply Through Our Website for Better Visibility
When you find roles that excite you, especially at places like Parexel, don’t forget to apply through our website. This can sometimes give you an edge by showing the employer you’re savvy and committed to finding the right fit.
We think you need these skills to ace Senior Medical Writer - UK or Ireland - FSP in Uxbridge
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at Parexel.
Showcase Your Administrative Skills:Administrative skills are key in this field, so don’t hold back! Make sure your CV reflects your proficiency in things like scheduling, data management, and compliance with health regulations. Mention specific software you’ve used, such as patient management systems, as this will demonstrate your hands-on abilities and readiness for the role at Parexel.
Craft a Meaningful Cover Letter:Your cover letter should reflect your passion for the health sciences field and your eagerness to contribute to Parexel. Share a bit about why you’re drawn to this sector, any impactful situations or challenges you’ve encountered, and how they’ve shaped your desire to work in health sciences administration. This personal touch can really set you apart!
Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at Parexel. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at Parexel
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
✨Prepare for Scenario Questions
Interviews for administrative roles often involve scenario-based questions to assess your problem-solving skills. Practice responses to common situations you might face, such as dealing with a challenging patient or managing a sudden schedule change. This will not only demonstrate your ability to think on your feet but also highlight your interpersonal skills.
✨Align Your Goals with the Organisation
As a full-time candidate, employers will want to know how your long-term career goals align with their mission. Take some time to research Parexel’s values and be ready to tie your passion for health sciences administration into their objectives. Demonstrating enthusiasm and career alignment can be a game-changer in this competitive field!
