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- Tasks: Plan and author clinical documents, ensuring quality and compliance for global submissions.
- Company: Join METRONOMIA, a growth-oriented company known for its commitment to quality and employee value.
- Benefits: Enjoy hybrid working, attractive pay, and comprehensive benefits in a supportive environment.
- Why this job: Make a real impact in clinical research while developing your skills in a collaborative team.
- Qualifications: Degree in life sciences with experience in regulatory document preparation and strong communication skills.
- Other info: Opportunities for training and career growth in a flat hierarchy.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Since 1990, METRONOMIA has stood for quality, competence, continuity and unconditional customer orientation in terms of data management, statistical services and medical writing in clinical research. As a growth-oriented medium-sized company with over 150 employees, we operate internationally. Our customers appreciate the competence and commitment of our employees and we value our employees as the basis of the company's success.
Your responsibilities:
- Plan, author, and finalize clinical and regulatory documents, including clinical study protocols and amendments, investigator’s brochures and updates, clinical study reports, development/periodic safety update reports, risk‑based safety narratives, and clinical/summary modules for global submissions.
- Translate statistical outputs into clear, compliant narratives and summaries aligned with SAPs and ICH guidance.
- Drive document quality control and proofreading to submission-ready standards.
- Coordinate, collect, and compile source materials from cross‑functional trial teams for CSR appendices and eCTD components.
- Manage timelines, reviews, and comment reconciliation across Clinical, Biostatistics, Pharmacovigilance, Regulatory, and Data Management.
Requirements:
- Degree in life sciences, public health, or related field with strong understanding of drug development and clinical trials.
- Proven track record delivering submission-grade regulatory documents (e.g., CSRs, protocols, IBs, DSURs, Module 2 clinical summaries, submission dossiers) within clinical development environments.
- Mastery of relevant ICH and regional guidance; adherence to SOPs and templates.
- Excellent written and oral English; meticulous attention to detail and data integrity.
- Effective time management and the ability to work independently and in cross‑functional teams; accountable for deliverables and timelines.
- Clear, solution‑oriented communicator with sound judgment on when to elevate issues.
Our offer for you:
- Appreciation and family-friendliness: hybrid working models and a culture that values you as a person.
- Excellence is worth it: attractive remuneration and comprehensive company benefits.
- Flat hierarchy: we collaborate at eye level to foster a motivated, high‑quality team environment.
- Challenging tasks: thorough onboarding and regular opportunities for internal and external training.
Have we piqued your interest? We look forward to getting to know you! Please send us your CV or your LinkedIn profile and a short cover letter including details of your possible start date and salary expectations. If you have any questions about the position and the application process, please do not hesitate to contact our HR Manager Christoph Hortian.
Senior Medical Writer (UK based) in London employer: Metronomia Clinical Research GmbH
Contact Detail:
Metronomia Clinical Research GmbH Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer (UK based) in London
✨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 that a CV alone can't.
✨Tip Number 2
Showcase your expertise! Prepare a portfolio of your best work, including submission-grade documents you've authored. This will give potential employers a taste of what you can bring to their team.
✨Tip Number 3
Practice makes perfect! Get ready for interviews by rehearsing common questions and scenarios related to clinical writing. The more comfortable you are, the better you'll shine during the real deal.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining our fantastic team at METRONOMIA.
We think you need these skills to ace Senior Medical Writer (UK based) in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Medical Writer role. Highlight your experience with clinical documents and any relevant qualifications. We want to see how your background aligns with what we do at METRONOMIA!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about medical writing and how you can contribute to our team. Keep it concise but engaging – we love a good story!
Showcase Your Attention to Detail: As a medical writer, attention to detail is key. Make sure your application is free from typos and errors. We appreciate meticulousness, so let that shine through in your written materials!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Metronomia Clinical Research GmbH
✨Know Your Documents Inside Out
As a Senior Medical Writer, you'll be dealing with clinical and regulatory documents. Make sure you’re familiar with the types of documents mentioned in the job description, like clinical study protocols and investigator’s brochures. Brush up on ICH guidelines and be ready to discuss how you've applied these in your previous roles.
✨Showcase Your Attention to Detail
This role demands meticulous attention to detail. During the interview, highlight specific examples where your proofreading or quality control efforts made a significant impact. Bring along samples of your work if possible, as this will demonstrate your commitment to producing submission-ready documents.
✨Demonstrate Cross-Functional Collaboration
You’ll need to coordinate with various teams, so be prepared to discuss your experience working in cross-functional environments. Share stories that illustrate your ability to manage timelines and reconcile comments from different stakeholders, showcasing your communication skills and solution-oriented mindset.
✨Prepare Questions That Matter
Interviews are a two-way street! Prepare thoughtful questions about the company culture, team dynamics, and the onboarding process. This shows your genuine interest in the role and helps you assess if METRONOMIA is the right fit for you. Plus, it gives you a chance to engage with your interviewers on a deeper level.
