Senior / Principal Medical Writer (UK based)
Location: UK Remote (with a permanent residence in the UK)
Employment type: Full-time (40 hours)
We are looking for an enthusiastic and dynamic Medical Writer with demonstrable experience (typically built over several years) in authoring regulatory documents to join our Medical Writing Team.
Your responsibilities
- Project management of medical writing tasks including, preparation and tracking of timelines and budget, tracking reviews, and comment reconciliation across Clinical, Biostatistics, Pharmacovigilance, Regulatory, and Data Management.
- Customer facing role, including attending bid defense meetings as required.
- Plan, author, and finalise clinical and regulatory documents, including clinical trial protocols (CTP) and amendments, investigator’s brochures (IB) and updates, clinical trial reports (CTR), development/periodic safety update reports (DSUR/PSUR), participant narratives, and clinical/summary modules for global submissions.
- Translate statistical outputs into clear, compliant summaries aligned with statistical analysis plans (SAPs) and relevant regulatory guidance.
- Drive document quality control and proofreading to submission-ready standards.
- Guidance of less experienced medical writers.
Your profile
- A degree (BSc) — ideally complemented by a higher degree (MSc/PhD) — in a relevant life sciences field, with a strong understanding of drug development, data interpretation and clinical trials.
- A proven track record as lead author of submission-grade regulatory documents (e.g. CTRs, protocols, IBs, DSURs, Module 2 clinical summaries, submission dossiers) within clinical development environments.
- Sound knowledge of relevant regulatory and data standards (e.g. ICH, CDISC) and regional guidance, with a disciplined approach to SOPs and templates.
- Excellent written and spoken English, with meticulous attention to detail and a commitment to data integrity.
- Effective time management and the ability to work both independently and within cross-functional teams, taking ownership of deliverables and timelines.
- A clear, solution-oriented communicator with sound judgement on when to decide and when to escalate.
What we offer
- Recognition and a family-friendly culture: hybrid working models and a workplace that values you as a person.
- Reward that reflects your contribution: competitive remuneration and a comprehensive benefits package.
- Health and wellbeing: employer-funded private medical insurance on successful completion of your probationary period.
- Flat hierarchies: we work together as equals to build a motivated, high-quality team.
- Engaging work: a thorough onboarding and regular opportunities for internal and external training and development.
Have we piqued your interest? We look forward to getting to know you!
Upload your Cover Letter and CV or LinkedIn profile, including potential start date and compensation expectations via our career page below. If you have any questions in advance don’t hesitate to contact our HR Managers Lachaé Leo (lleo@metronomia.net) or Christoph Hortian (chortian@metronomia.net).
Metronomia Clinical Research (UK) Ltd. – Career – Metronomia GmbH
Eligibility: This role is not eligible for visa sponsorship. Applicants must already be based in the UK and hold an unrestricted, ongoing right to work here that does not require sponsorship now or in the future (for example, British or Irish citizenship, or indefinite leave to remain / settled status). Time limited permissions, including the Graduate (post-study) visa and the Global Talent visa, do not meet this requirement, as the position cannot be sponsored when they expire.
Metronomia is an equal opportunities employer. We welcome applications from all suitably qualified candidates and are committed to a fair and inclusive recruitment process. If you require any reasonable adjustments at any stage, please let us know.
To apply for this job please visit metronomia.kenjo.io.