Non-Clinical Expert/Toxicologist (m/w/d)
Your Tasks:
Creation and maintenance of non-clinical documentation for medicinal products, e.g., CTD modules 2.4 and 4 in alignment with Global Drug Regulatory Affairs and other relevant stakeholders
Responsibility for the content of the above-mentioned regulatory information (subject matter expert)
Function as non-clinical expert, e.g. for CTD module 1.4.2
Provide answers to questions raised in context of marketing authorization applications, variation procedures and audits/inspections within the timelines provided by the authority
Proactively align with other stakeholders (e.g. clinical, pharmacovigilance, regulatory, labelling) if required in line with evaluation of non-clinical information or information overlapping with the topics of these stakeholder on own initiative
Serve as internal and external contact point for non-clinical topics
Define non-clinical strategy for medicinal products , especially in development projects for new medicinal products, as a member of cross-functional teams
Regular review of existing non-clinical documentation for medicinal products for need of updates according to the most recent scientific and technical knowledge and relevant guidelines. Update of documentation in alignment with relevant stakeholders if required
Support projects increasing foot-print of FME in future markets/establishing new marketing authorizations globally
Your Profile:
Graduate Degree in Sciences
Toxicologist, ideally certified (European registered toxicologist or American board of toxicologists certified)
Specialist trainings on creation of non-clinical drug dossier parts
Deep knowledge of drug development and registration process
Minimum of 3-5 years experience in a similar role
Strong project management skills, highly structured and systematic working style
Excellent stakeholder management and communication skills, supporting transparent dialogue without avoiding conflicts
ability to present and explain complex subjects convincingly to stakeholders from all levels
Fluent in business English
Any other additional language skills are a plus, e.g., German
Willingness to continuously learn and adapt to changing environments
Ability to interact with all management levels to influence positive change
Willingness for (limited) business travel
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.