Associate Director, Worldwide Medical, Established Brands Portfolio
Company: Disability Solutions
Location: Princeton
Posted on: May 3, 2024
Job Description:
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 .Position SummaryThe Established
Brands Associate Director is responsible for strategy and execution
of medical affairs-related activities for brands in the Established
Brands portfolio, with focus on the Hematology and Oncology
therapeutic area.Key Responsibilities
- Working closely with the Team Lead and the Worldwide
Established Brands team, provide medical oversight and manage WW
medical activities for the Hematology and Oncology brands within
the expanding Established Brands Organization.
- Lead global medical activities in support of strategic
execution of plans in regions where brand continues to be actively
commercialized and develop and execute medical strategy for
expansion into new markets.
- Provide medical assessments of risk/benefit of assigned
products regarding new indications, safety or stability/quality
issues, medical necessity/sensitivity assessments or other actions
that require reappraisal of the product Risk/Benefit.
- Partner with medical subject-matter experts from WW Hematology
and Oncology Therapeutic Area teams and Market medical teams to
provide strategic input to Loss-of-Exclusivity planning and
transition to Established Brands portfolio.
- Work closely with key cross-functional matrix partners:
Commercial, Regulatory, Safety, Labeling, Supply & Manufacturing,
Quality & Compliance to support brand activities (e.g., labeling,
safety, quality, deletions).
- Lead medical insight at cross-functional teams, including
revaluation of WW medical content, local market needs, and labeling
recommendations based on proactive signal detection
activities.
- Provide medical input for regulatory requirements including
response to Health Authorities queries, support for registration
renewals and label periodic reviews.
- Provide medical support and input to the CCDS content review
and development.
- Provide medical evaluation and appropriate communications to
additional documents and activities such as: Dear Health Care
Professional letters, Clinical Overview for Type II variation and
coordinate expert reports.
- Provide clinical trial expertise for new evidence generation
needs or health-authority commitment studies.
- Compliance Support delivery of medical affairs compliance needs
for the assigned portfolio, as appropriate.
- Demonstrate ability to apply BMS operating philosophy and
operate within company policies and procedures and appropriate
regulations.
- Management, as appropriate, of the budget allocated to the
specific projects.Qualifications & Experience
- MD, PharmD, PhD or Equivalent.
- MD with Medical specialty in Hematology or Oncology strongly
preferred.
- 7-10 years of clinical and pharmaceutical industry
experience.
- Excellent oral and written communication skills.
- Demonstrate flexibility, open mindedness, and adaptability in a
rapidly changing environment.
- Ability to promote collegiality and teamwork, as well as to
think clearly and decisively when presenting independent, reasoned
solutions to identified safety issues
- Experience Desired
- Knowledgeable and skilled in medicine and pharmaceutical
product preferably related to both clinical trial and
post-marketing safety.
- Familiarity with regulatory guidelines.
- Considerable Multi-Brand Medical Affairs and
Pharmacovigilance-Safety experience would be an
advantage.#LI-HybridIf 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
Protocol BMS has a diverse occupancy structure that determines
where an employee is required to conduct their work. This structure
includes site-essential, site-by-design, field-based and
remote-by-design jobs. The occupancy type that you are assigned is
determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned
facility. Site-by-design roles may be eligible for a hybrid work
model with at least 50% onsite at your assigned facility. For these
roles, onsite presence is considered an essential job function and
is critical to collaboration, innovation, productivity, and a
positive Company culture. For field-based and remote-by-design
roles the ability to physically travel to visit customers, patients
or business partners and to attend meetings on behalf of BMS as
directed is an essential job function. 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 adastaffingsupport@bms.com . Visit careers.bms.com/
eeo -accessibility to access our complete Equal Employment
Opportunity statement. BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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.
Keywords: Disability Solutions, Trenton , Associate Director, Worldwide Medical, Established Brands Portfolio, Executive , Princeton, New Jersey
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