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Job Details

Principal Scientist Operations GLP Study Director

Company name
Johnson & Johnson Services, Inc.

Cincinnati, OH

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DePuy Synthes, a Johnson & Johnson FamilyCompany, is recruiting for a Principal Scientist to be located in Cincinnati, OH. DePuy Synthes Companies of Johnson &
Johnson is the largest, most innovative and comprehensive orthopedic and
neurological business in the world. DePuy Synthes Companies offer an
unparalleled breadth and depth of products, services and programs in the areas
of joint reconstruction, trauma, spine, sports medicine, neurological,
craniomaxillofacial, power tools and biomaterials. Building on the legacy and
strengths of two great companies, more agile and better equipped to meet the
needs of today\u2019s evolving health care environment. With a focus on activating
insights to develop innovative, comprehensive solutions, we are inspired to
advance patient care in greater ways than either company could accomplish on
its own. Thriving on a diverse company culture,
celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. The Principal Scientist in Operations of the
Preclinical Center of Excellence (COE) will provide oversight and scientific
support for non-GLP and GLP preclinical studies in support of medical device
(MD) products for general and laparoscopic surgery, orthopedics,
electrophysiology, cardiovascular and robotics. This individual with work closely Preclinical project leaders across the
MD sector to direct and execute preclinical studies including the development
and execution of study protocols, analysis of data, and interpretation and
reporting of results on in vivo and cadaver studies conducted in the COE
facilities across the MD sector. As a Principal Scientist responsibilities will
include: Responsible for ensuring executional
excellence of preclinical studies performed at COE facilities on platforms
across multiple business unitsFacilitate support for the conduct,
monitoring and reporting, of non GLP and GLP preclinical studies in COE
facilities via the coordination of communications, paperwork, and test\/control
article logistics between the study coordinator and project leaders across many
platforms and franchisesManages Operations Associate Scientist and
ScientistsResponsible for the drafting of study
protocols and reports for assigned studies. Partners with the project leaders and contributing scientists to
incorporate input into protocols and reportsResponsible for drafting IACUC protocol
development and its approval to meet study deadlineAccountable for ensuring all data forms are
drafted, completed and incorporated into the final reportConducts pre-study meeting with study related
staff to train to protocolPartners closely with contract staff
(Research Assistants and Surgical Vet Technicians) assigned to studies to
ensure that study related tasks are completed per the study level RACI and in
accordance according the study protocol to ensure executional excellenceResponsible for addressing audit findings
associated with internal studiesMay serve as study surgeon and evaluate
device prototypes per study protocolsServes as the single point of contact with
the project leader to communicate timelines, issues and milestones regarding
study conductResponsible for assembling data and preparing
data for analysisPartners with the data integrity team to
ensure QC of dataAccountable for archiving of study related
materials per proceduresPartners with Preclinical Resource manager
and other staff to identify procedures and work instructions that facilitate
improvements in study conduct and communication for internal studiesProvides model development and\/or surgical
support to project leaders across many platforms and franchises, as neededQualifications Bachelor\u2019s degree with a minimum of 10 years of experience OR Master\u2019s
degree with a minimum of 8 years OR a PhD with a minimum of 5 years of
experience is required Experience with medical devices as a GLP Study Director\/Principal
Investigator in a contract research organization, academic or industry lab is
required Demonstrated in depth
knowledge of 21 CFR part 58 and its requirements
in relation to the execution of GLP studies is requiredExperience with a broad spectrum of medical devices
(surgical, orthopedics, cardiovascular, etc.) is preferredDemonstrated ability to engage and develop relationships
with project leaders to facilitate study execution is requiredDemonstrated ability to multi-task and organize multiple
studies is requiredExcellent
communication and organizational skills \u2013 written\/oral\/listeningUp to 5% travel may
be required

Company info

Johnson & Johnson Services, Inc.
Website :

Company Profile
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Johnson & Johnson was founded more than 120 years ago. Since then, we’ve brought the world new ideas and products that have transformed human health and well-being.

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