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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 appreciation.
- Benefits: Enjoy hybrid working models, attractive remuneration, and comprehensive company benefits.
- Why this job: Make a real impact in clinical research while collaborating with a motivated and friendly team.
- Qualifications: Degree in life sciences and proven experience in delivering regulatory documents.
- Other info: Flat hierarchy with excellent training opportunities and a focus on personal development.
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 (+49 89 829 265 101 / chortian@metronomia.net).
Senior Medical Writer (UK based) 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)
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical writing field and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH guidelines and regulatory documents. Be ready to discuss your past experiences with submission-grade documents, as this will show you're the right fit for the role.
✨Tip Number 3
Showcase your attention to detail! During interviews, highlight specific examples where your meticulous nature made a difference in document quality or project timelines. This will resonate well with potential employers.
✨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 you're genuinely interested in joining our team at METRONOMIA.
We think you need these skills to ace Senior Medical Writer (UK based)
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’re looking for!
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 your skills can contribute to our team. Keep it concise but impactful – 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 application!
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’s super easy – just a few clicks and you’re done!
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.
✨Communicate Clearly and Effectively
Effective communication is key in this position. Practice articulating complex ideas simply and clearly. Be prepared to explain how you’ve translated statistical outputs into narratives in past projects. This will show that you can bridge the gap between technical data and clear communication.
✨Demonstrate Your Teamwork Skills
Since the role involves coordinating with cross-functional teams, be ready to discuss your experience working collaboratively. Share examples of how you managed timelines and reconciled comments across different departments. This will illustrate your ability to work independently while also being a team player.
