Executive Director, GRS International Oncology Lead
Jobbeschreibung
Boudry, Neuenburg, Schweiz
Bristol-Myers Squibb
27.04.2024
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Working with UsChallenging. Meaningful. Life-changing. Those aren’t
words that are usually associated with a job. But working at Bristol
Myers Squibb is anything but usual. Here, uniquely interesting work
happens every day, in every department. From optimizing a production
line to the latest breakthroughs in cell therapy, this is work that
transforms the lives of patients, and the careers of those who do it.
You’ll get the chance to grow and thrive through opportunities
uncommon in scale and scope, alongside high-achieving teams rich in
diversity. Take your career farther than you thought possible.Bristol
Myers Squibb recognizes the importance of balance and flexibility in
our work environment. We offer a wide variety of competitive benefits,
services and programs that provide our employees with the resources to
pursue their goals, both at work and in their personal lives. Read
more: careers.bms.com/working-with-us.Executive Director, GRS
International Oncology LeadFunctional 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 Oncology Lead is a member
of the Global Regulatory Sciences (GRS) International Leadership 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 patientsUrgencyWe move together with speed and
quality because patients are waitingPassionOur dedication to learning
and excellence helps us to deliver exceptional resultsAccountabilityWe
all own BMS’ success and strive to be transparent and deliver on our
commitmentsInclusionWe embrace diversity and foster an environment
where we can all work together at our full potential.Degree
Requirements Strong scientific/medical background/university
scientific degreeExperience RequirementsExperience in Oncology is
requiredMinimum of 5 to 10+ years of global regulatory experience and
drug development expertiseKey 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 valuesIf you come across a role
that intrigues you but doesn’t perfectly line up with your resume, we
encourage you to apply anyway. You could be one step away from work
that will transform your life and career.Uniquely Interesting Work,
Life-changing CareersWith a single vision as inspiring as
“Transforming patients’ lives through science ”, every BMS employee
plays an integral role in work that goes far beyond ordinary. Each of
us is empowered to apply our individual talents and unique
perspectives in an inclusive culture, promoting diversity in clinical
trials, while our shared values of passion, innovation, urgency,
accountability, inclusion and integrity bring out the highest
potential of each of our colleagues.On-site ProtocolPhysical presence
at the BMS worksite or physical presence in the field is a necessary
job function of this role, which the Company deems critical to
collaboration, innovation, productivity, employee well-being and
engagement, and it enhances the Company culture.BMS is dedicated to
ensuring that people with disabilities can excel through a transparent
recruitment process, reasonable workplace accommodations/adjustments
and ongoing support in their roles. Applicants can request a
reasonable workplace accommodation/adjustment prior to accepting a job
offer. If you require reasonable accommodations/adjustments in
completing this application, or in any part of the recruitment
process, direct your inquiries to Visit
careers.bms.com/eeo-accessibility to access our complete Equal
Employment Opportunity statement.BMS will consider for employment
qualified applicants with arrest and conviction records, pursuant to
applicable laws in your area.Any data processed in connection with
role applications will be treated in accordance with applicable data
privacy policies and regulations.
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