In this role you are responsible for effectively managing global studies for validation of diagnostic products in cooperation with external and internal experts, while assuring compliance to regulatory requirements.
You will work in interdisciplinary teams within the Roche Organization in Germany and abroad. Right from the start, you will take responsibility in your projects, providing you with ample opportunity to gain visibility based on your achievements and results.
Responsibilities will include:
· Developing study design in coordination with internal/external experts and the development/project team
· Managing the study team with accountability for the study with respect to quality, cost and timelines
· Arranging meetings, preparing and monitoring study plans, data reports, briefing documents, global design validation and recommendation plans in a timely fashion
· Cooperating with Regulatory affairs to support pre-submission process
· Planning of the study specific content and budget within the development/project team and controlling the related agreed upon budgets during the study
· Ensuring compliance to all relevant Roche safety and QM procedures in all studies
· Working collaboratively across therapeutic areas with different internal teams and external stakeholders
· Consulting, advising and counseling when appropriate, business customers, Regulatory Affairs, Clinical Operations and across Business units
· Initiating and ensuring contacts to international experts and customer groups to use the external know-how for the development of new products and to support acceptance of new products
· Maintaining regular communication with key stakeholders to ensure that timely, relevant information is provided and that issues or matters requiring attention are discussed and addressed promptly
· Networking and interfacing with internal colleagues to share information and best practices while remaining actively involved in industry/customer organizations that impact business.
This challenging training on the job will be complemented by an intensive training off the job. This includes trainings and workshops to improve your soft-skills and your business understanding, regular feedback and mentoring and various opportunities to build a network within the local and global Roche Organization. Together we’re working on the development of your leadership potential, to prepare you for further leadership responsibility.
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
· MD, PhD in Natural Sciences or equivalent education/qualifications in lab diagnostics, or nursing equivalent
· In depth knowledge in a therapeutic or diagnostic area
· Experienced in biochemical, chemical or biophysical area with detailed knowledge in specific fields of diagnostics (e.g. coagulation, hemostasis)
· Excellent organizational and communication skills, sense of responsibility, accuracy and urgency and the ability to adjust to new challenges
· Project management skills
· Team player with an inter-disciplinary and inter-cultural sensitivity and work experience
· Superior verbal, written and interpersonal communication skills in German & English
· Willingness to travel (30%)
· Creative and innovative thinking ‘out-of-the-box’
· Statistical knowledge
· First leadership experiences in diverse, virtual teams welcome
If thoses goals correspond to your professional ideas, we are looking forward to receiving your complete application documents.
Roche ist ein Arbeitgeber, bei dem Chancengleichheit zählt.
Research & Development, Research & Development > Research
· Who we are
Die Roche Diagnostics GmbH (RDG) ist mit mehr als 12.000 Mitarbeitern der drittgrößte Standort im Konzern. Neben den Vertriebsorganisationen in Deutschland (Roche Pharma AG und Roche Diagnostics Deutschland) fokussiert die RDG auf das operative Geschäft. In den beiden Standorten Mannheim und Penzberg werden neue diagnostische Tests und pharmazeutische Wirkstoffe für den weltweiten Markt entwickelt und produziert.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.