Non-Clinical Expert/Toxicologist

vor 2 Monaten

Bad Homburg, Deutschland Fresenius Medical Care Vollzeit

Your Tasks:

Creation and maintenance of non-clinical documentation for medicinal products, , CTD modules 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, for CTD module

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 ( 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, , 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 purposeWe offer an opportunity to create and deliver treatments that save and change lives for the better. We’ll support your ongoing development. And you’ll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day. Inclusion and diversityJoining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued. StabilityDeveloping innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our 125000 employees with the stability and security they need to help improve the lives of our patients. Learning and developmentWe offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7. Local benefitsOur employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere. Work-life balanceWe want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.

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