Medical Writer

vor 2 Wochen

Munich, Deutschland Staburo GmbH Vollzeit

**Your responsibilities will include**:

- Writing protocols, study reports, patient narratives, and other study documents
- Writing documents for the lay public like plain language summaries and lay protocol synopses
- Authoring of protocol registrations and results postings for submission to local and global regulatory agencies
- Review of study protocols, amendments, and reports for disclosure readiness
- Maintenance of international clinical trial registries and results records on public databases including status tracking and administrative aspects
- Managing timelines for submission of all registrations and postings to ensure compliance with international laws, regulations, and guidelines
- Communicate and coordinate with international study teams, act as a central point of contact

**Your profile**:

- Bachelor’s, Master’s or PhD degree in a health or life science related discipline
- 1+ year(s) experience in medical writing
- Knowledge of drug development and clinical science
- Knowledge of the clinical trials disclosure regulatory environment and experience with Clinicaltrials.gov, CTIS and/or EudraCT is a plus
- Work experience in a CRO or pharma/biotech is a plus
- Fast comprehension, analytical thinking, teamwork and a high degree of initiative, willingness to learn
- Excellent organizational and time management skills, highly detail-oriented
- Fluent in English

**What we offer you**:
We value communication, flat hierarchies, open corporate culture, and a harmonious work environment. We offer comprehensive individual development opportunities, continuous trainings, and flexible working hours. A modern and bright office with a subsidised canteen, as well as the opportunity to work 2 days per week from home are part of our everyday working life. Full remote work from anywhere in Germany for those who do not live in Munich can be discussed. You will join an interdisciplinary team allowing you to discuss with and learn from peers with many different backgrounds.

**Question?**:
**About us**:
Staburo GmbH is a data science company, specialized in statistical consulting, programming and bioinformatics for healthcare projects. Our core competencies include Clinical Statistics, Translational Medicine & Biomarkers, Phase I & Pharmacokinetics/-Dynamics, Data Transparency & Disclosure Services, Health Technology Assessment and Bioinformatics. Our customers are international pharmaceutical companies, CROs, biotech companies and medical device manufacturers. Our steadily growing team supports our clients efficiently from study design to data analysis and finally the disclosing and posting of trial results.

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