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Senior Scientist, Operations (GLP Study Director)
Requisition ID: 5733180312
DePuy Synthes, a Johnson & Johnson Family Company, is recruiting for a Senior 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’s 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 Senior 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 Senior Scientist responsibilities will include:
- Responsible for ensuring executional excellence of preclinical studies performed at COE facilities on platforms across multiple business units.
- Facilitate 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 franchises.
- Responsible 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 reports.
- Responsible for drafting IACUC protocol development and its approval to meet study deadline.
- Accountable for ensuring all data forms are drafted, completed and incorporated into the final report.
- Conducts pre-study meeting with study related staff to train to protocol.
- Partners closely with ontract 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 excellence.
- Responsible for addressing audit findings associated with internal studies.
- May serve as study surgeon and evaluate device prototypes per study protocols.
- Serves as the single point of contact with the project leader to communicate timelines, issues and milestones regarding study conduct.
- Responsible for assembling data and preparing data for analysis.
- Partners with the data integrity team to ensure QC of data.
- Accountable for archiving of study related materials per procedures.
- Partners with Preclinical Resource manager and other staff to identify procedures and work instructions that facilitate improvements in study conduct and communication for internal studies.
- Provides model development and/or surgical support to project leaders across many platforms and franchises, as needed.
- Bachelor’s degree with a minimum of 7 years of experience OR Master’s degree with a minimum of 5 years OR a PhD with a minimum of 3 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 required
- Experience with a broad spectrum of medical devices (surgical, orthopedics, cardiovascular, etc.) is preferred
- Demonstrated ability to engage and develop relationships with project leaders to facilitate study execution is required
- Demonstrated ability to multi-task and organize multiple studies is required
- Excellent communication and organizational skills – written/oral/listening
- Up to 5% travel may be required
Depuy Orthopaedics. Inc. (6029)