Executive Director, Grs International Oncology Lead > Bristol Myers Squibb > Joboolo CH :
Company : Bristol Myers Squibb Location : Boudry Neuchâtel From : Neuvoo CH
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ExecutiveDirector, GRS InternationalOncologyLead Functional Area DescriptionResponsible for providing International regulatory strategic support to global development programs and executing Health Authority negotiations in line with BMS strategy for assigned projects in the defined therapeutic area.
Position SummaryThe GRS Int OncologyLead is a member of the Global Regulatory Sciences (GRS) InternationalLeadership Team, reporting to the VP of GRS International.
This leader will collaborate with the GRS International LT and broader regional and global TA organization to enable and drive portfolio delivery for regions including EU and Intercon.
Position Responsibilities:
Integrates the European and Intercon regulatory, legal, scientific/medical and business perspectives to achieve the optimal regulatory outcomes in accordance with company objectives.Translates strategy into operational goals and objectives, identifies resources and leads to organization to focus on objectives.Ensures that organization follows through to achieve high quality execution of plans.Contributes and adds value to the writing of scientific documents for regulatory purpose.Executes negotiations with EMA and ensure negotiations with HA in Intercon markets are in line with BMS strategy and provides strategic directions and supervises negotiations with other relevant regulatory agencies for assigned project.Provides direction for maximizing opportunities within projects (e.G.
life-cycle) and across the geographical area to support the productivity priorities.Participates actively in and represents Global Regulatory Sciences for their project on various multifunctional committees or teams.Communicates actively and timely with Global Regulatory Sciences colleagues in European countries, and countries in the International region, including through direction of International Regulatory Teams.Active participation in regional organizational activities for the regulatory regional Lead function (across projects).Develops strong working relationships with key stakeholders both within and outside the company.Builds and maintains strong relationships with alliance partners when applicable.Watches, anticipates and acts on trends and changes in the European.Integrates cross-country regulatory issues/feedback, cross-asset regulatory issues/events to resolve issues.Closely monitors the evolving external environment for specific topics as assigned, liaises with appropriate internal stakeholders, raises awareness internally and participates in issue resolutionRepresents GRS International in internal and external regulatory strategy meetings and participates in issue resolution, as appropriate and as agreed.
Core BMS Leadership Values IntegrityWe demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
InnovationWe pursue disruptive and bold solutions for patients UrgencyWe move together with speed and quality because patients are waiting PassionOur dedication to learning and excellence helps us to deliver exceptional results AccountabilityWe all own BMS’ success and strive to be transparent and deliver on our commitments InclusionWe embrace diversity and foster an environment where we can all work together at our full potential.
Degree Requirements Strong scientific/medical background/university scientific degree Experience RequirementsExperience in Oncology is requiredMinimum of 5 to 10+ years of global regulatory experience and drug development expertise Key Competency Requirements Conducted prior negotiations with (a) regulatory authority(ies)Contributed to scientific documents developed for regulatory purposes, established credibility and respect during previous exposure with regulatory authorities and peersDemonstrated ability to react appropriately in difficult, possibly adverse, conditions and/or in crisis situationsDemonstrated ability to integrate regulatory, scientific/medical and business perspectives and to translate this analysis into practical recommendations and operational goalsDeveloped working relationships and/or built a team resulting in a performant network or organizationManagerial experience (e.G.
prior team leadership)Strong understanding of requirements and exposure to international regulatory environmentStrong global regulatory strategy/drug development experience, scientific expertiseStrong track record of ability to effectively negotiate and drive health authority interactionsAbility to supervise ERLs and IRLs and provide strategic guidance for their projects.Understanding of pharmaceutical product development.Understanding of EU regulatory principles and their impact on company’s development and business, as well as knowledge of HA requirements across regions within the International region.Understanding of the complexities of cross functional management issues.Understanding of legal and business aspects related to EU and other International HA regulatory procedures and outcomesCompetent in “Regulatory Science”Leadership skillsCultural sensitivity and capability to manage a multinational regulatory organization and implement appropriate plans.Demonstrated Company behavioral attitude and living BMS values Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen.
Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.
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