A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: You will lead the Medical Writing efforts for global pharmaceutical programs. Deliverables include CTD clinical summaries and overviews in CTD format for submission to FDA and EMA, Briefing Books, regulatory response documents and Pediatric Plans. You will also oversee outsorcing of Clincial Study Protocols, Clinical Study Reports, and Investigator’s Brochures. You represent the department on clinical teams, lead document-related meetings, and review statistical analysis plans. In addition you contribute to the overall project management and to cross-functional working groups to facilitate efficient development and finalization of regulatory documents for submission. Further, you provide document strategy and organize resource needs for MW to support an indication/program. You attend governance meetings for clinical study protocol discussions and proactively contribute to the development and implementation of MW best practices and improvements. Travelling up to 10% will be part of this role, remote work after onboarding and with availability for onsite meetings would be possible.
Who you are:
- Minimum four years’ experience in Regulatory Medical Writing
- Solid knowledge about CTD documents, Clinical Study Reports, Study Protocols, and Investigator Brochures,
- Experience in EDMS use.
- Excellent time and priority management, work efficiently under pressure
- Strong communication and organizational skills
- Fluent in English (oral and written) – knowledge of an additional language may be beneficial
- Work location: Germany (Darmstadt)
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com