Associate Director, EU Regulatory Strategy Oncology
Infos sur l'emploi
Date de publication :
27 septembre 2023Taux d'activité :
100%Type de contrat :
Durée indéterminée-
Lieu de travail :
Boudry
Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Ver?nderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, H?matologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielf?ltigsten und vielversprechendsten Pipelines der Branche - tr?gt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Ver?nderungen vorantreiben. Wir verleihen jeder Therapie, f?r die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb? und machen Sie einen Unterschied.
Expected Areas of Competence:
- Integrates the European regulatory, legal, scientific/medical and business perspectives to achieve the optimal regulatory outcomes for assigned project(s) in accordance with company objectives.
- Translates strategy into operational goals and objectives, identifies resources and leads the organization to focus on objectives.? Assures that organization follows through to achieve high quality execution of plans.
- Ability to contribute and add value to the writing of scientific documents for regulatory purpose.
- Able to act as Contact Person for assigned project(s) with EMA in line with BMS strategy and to provide strategic directions and supervise negotiations with other relevant regulatory agencies for assigned project.
- Provides direction for maximizing opportunities within projects (eg. lifecycle) and across the geographical area to support the productivity priorities.
- Participates actively in and represents GRS-EU for their project(s) in the Global Regulatory Team and on various multi-functional committees or teams.
- Communicates actively and timely with Global Regulatory Sciences colleagues in European countries, including through direction of European Regulatory Teams.
- Active participation in regional organizational activities for the Liaison function (across projects)
- Develops strong working relationships with key stakeholders both within and outside the company.
- Builds and maintains strong relationships with alliance partner when applicable.
- Watches, anticipates and acts on trends and changes in the European and international regulatory environment which may impact on the business.
Core BMS Leadership Values
Integrity
We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
Innovation
We pursue disruptive and bold solutions for patients
Urgency
We move together with speed and quality because patients are waiting
Passion
Our dedication to learning and excellence helps us to deliver exceptional results
Accountability
We all own BMS' success and strive to be transparent and deliver on our commitments
Inclusion
We embrace diversity and foster an environment where we can all work together at our full potential.
Experiences Desired:
- Experience in Oncology is required
- Conducted prior negotiations with (a) regulatory authority(ies)
- Contributed to scientific documents developed for regulatory purpose.
- Established credibility and respect during previous exposure with regulatory authorities and peers
- Demonstrated ability to react appropriately in difficult, possibly adverse, conditions and/or in crisis situations
- Demonstrated ability to integrate regulatory, scientific/medical and business perspectives and to translate this analysis into practical recommendations and operational goals
- Developed working relationships and/or build a team resulting in a performant network or organization
- Demonstrated values, behaviors, professional standards and cultural sensitivity compatible with BMS vision and culture.
?Knowledge Desired:
- Strong scientific/medical background.
- Understanding of pharmaceutical product development
- Understanding of European regulatory principles and their impact on company's development and business
- Understanding of the complexities of cross functional management issues
- Understanding of legal and business aspects related to European regulatory procedures and outcomes.
- Compatible with BMS vision and culture.
Developmental Value:
- Optimal position to learn and understand the perspectives of key stakeholders (both internal: R&D, Marketing, Legal, etc...and external: regulatory and public health authorities, scientific community).
- Gain increased understanding of company strategies, decision processes and implementation processes.
- Learn to leverage personal impact by addressing complexity, setting priorities, translating strategies into operational goals and objectives, and exerting leadership to enhance organizational performance.
Wir setzen uns auf der ganzen Welt leidenschaftlich daf?r ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrit?t bef?higen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das h?chste Potenzial jedes unserer Kollegen hervor.
Bristol Myers Squibb wei? um die Bedeutung von Balance und Flexibilit?t im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.
