Johnson & Johnson companies are equal opportunity employers.
DIRECTOR EPIDEMIOLOGY, MEDICAL DEVICES & DIAGNOSTICS (MD&D)-7896140408
Description
Johnson & Johnson is recruiting for a Director, Epidemiology, Medical Devices & Diagnostics (MD&D) to be located in New Brunswick, NJ. The MD&D Safety & Surveillance Center of Excellence is seeking a Director, Epidemiology to provide research support to MD&D Operating Companies and drive medical safety and surveillance of MD&D products. This position reports to the Executive Director, Epidemiology at the office of Chief Medical Officer for MD&D.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The primary responsibilities of the Director in Epidemiology will be to work closely with the Executive Director to provide methodological guidance and leadership in epidemiology and post-market surveillance, with in-depth knowledge of registries, healthcare databases, and associated analytical methodology. Specific activities will include exploring and analyzing external electronic healthcare databases (insurance claims data, hospital billing data, EMRs, registries, etc.) to evaluate disease natural history, clinical and surrogate endpoints, and device benefit-risk questions and to improve the design and conduct of observational research. The person in this position will work closely with colleagues from MD&D Health Informatics and the Johnson & Johnson Epidemiology Department to define research questions, develop study protocols, and implement solutions. Participation in Epidemiology Department activities will also be encouraged.
The role will involve leadership and/or participation in various project teams and task forces in addressing issues raised by product teams or regulatory agencies, provide epidemiologic consulting and support to product teams, and disseminate technical information through technical reports, presentations, and publications in peer-reviewed literature, as agreed by the team.
Additionally, the Director will support the Postmarket Surveillance Initiative and further work to enhance safety and surveillance activities as part of product lifecycle management. The Director will work with the Executive Director in defining core processes in implementing Enterprise Safety Standards and organizational strategies, and leading their implementation. The Director will also work with other epidemiologists and statisticians to establish a robust signal analytic capabilities in safety and surveillance of MD&D products and share best practices across MD&D Operating Companies and other sectors; advance MD&D capabilities in research methodology by driving the Observational Study Advisory Committee processes in collaboration with other epidemiologists and researchers in related fields within Johnson and Johnson and outside; actively engage in and contribute to shaping the external environment through various partnerships outside of Johnson and Johnson (such as AdvaMed, MDEpiNet, and ISPE), and will be expected to participate in discussions with health authorities. Internally, the Director will enable innovation and growth by participating in the Independent Review process when epidemiologic expertise is needed; and deliver scientific input on FDA guidance documents as appropriate.
The Director will be expected to keep up-to-date with the FDA and other regulatory agencies regarding applications of electronic, patient-level databases and other emerging epidemiologic research tools. Exploring and developing new methodologies will be encouraged as will participation in external public-private partnerships with the aim of enhancing medical device safety capabilities. Work will also include, through existing databases and other tools, such as registries, researching natural history of diseases to understand the inherent risks associated with the indications for devices; statistical risk assessment; using clinical and non-clinical data sources to develop an understanding of potential safety issues for new devices and new indications; and planning and conducting systematic reviews of the literature and/or meta-analyses of safety data from various sources.
Qualifications
An advanced degree in epidemiology or related field is required, with a PhD, ScD, or MD with training and degree in epidemiology or related field (such as health economics, outcomes research) highly preferred. A minimum 7 years of epidemiology or related research experience in health care is also required. Pharmaceutical or medical device industry experience is highly preferred. A sophisticated understanding and the ability to interpret quantitative methods are required. Experience with writing Methods sections of study proposals/ protocols/ proposal requests or background epidemiologic material on specific disease or therapeutic areas is also required. Ability to perform duties in terms of stated objectives under general or minimum supervision. Proven leadership skills; ability to thrive in a global, matrix environment is required. Ability to influence, negotiate and communicate with both internal and external customers is required. Ability to develop, implement, communicate, and influence policy and strategy internally and externally to the company is required. Excellent verbal and written communication skills, including formal presentation skills are required. Strong collaborative and networking skills are required. There will be up to 20% Travel. This position will be based in New Brunswick, NJ.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. Johnson & Johnson companies are equal opportunity employers.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-New Jersey-Bridgewater
Organization: MD&D Global Services LLC (6209)
Job Function: Epidemiology
Relocation: Eligible No
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
DIRECTOR EPIDEMIOLOGY, MEDICAL DEVICES & DIAGNOSTICS (MD&D)-7896140408
Description
Johnson & Johnson is recruiting for a Director, Epidemiology, Medical Devices & Diagnostics (MD&D) to be located in New Brunswick, NJ. The MD&D Safety & Surveillance Center of Excellence is seeking a Director, Epidemiology to provide research support to MD&D Operating Companies and drive medical safety and surveillance of MD&D products. This position reports to the Executive Director, Epidemiology at the office of Chief Medical Officer for MD&D.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The primary responsibilities of the Director in Epidemiology will be to work closely with the Executive Director to provide methodological guidance and leadership in epidemiology and post-market surveillance, with in-depth knowledge of registries, healthcare databases, and associated analytical methodology. Specific activities will include exploring and analyzing external electronic healthcare databases (insurance claims data, hospital billing data, EMRs, registries, etc.) to evaluate disease natural history, clinical and surrogate endpoints, and device benefit-risk questions and to improve the design and conduct of observational research. The person in this position will work closely with colleagues from MD&D Health Informatics and the Johnson & Johnson Epidemiology Department to define research questions, develop study protocols, and implement solutions. Participation in Epidemiology Department activities will also be encouraged.
The role will involve leadership and/or participation in various project teams and task forces in addressing issues raised by product teams or regulatory agencies, provide epidemiologic consulting and support to product teams, and disseminate technical information through technical reports, presentations, and publications in peer-reviewed literature, as agreed by the team.
Additionally, the Director will support the Postmarket Surveillance Initiative and further work to enhance safety and surveillance activities as part of product lifecycle management. The Director will work with the Executive Director in defining core processes in implementing Enterprise Safety Standards and organizational strategies, and leading their implementation. The Director will also work with other epidemiologists and statisticians to establish a robust signal analytic capabilities in safety and surveillance of MD&D products and share best practices across MD&D Operating Companies and other sectors; advance MD&D capabilities in research methodology by driving the Observational Study Advisory Committee processes in collaboration with other epidemiologists and researchers in related fields within Johnson and Johnson and outside; actively engage in and contribute to shaping the external environment through various partnerships outside of Johnson and Johnson (such as AdvaMed, MDEpiNet, and ISPE), and will be expected to participate in discussions with health authorities. Internally, the Director will enable innovation and growth by participating in the Independent Review process when epidemiologic expertise is needed; and deliver scientific input on FDA guidance documents as appropriate.
The Director will be expected to keep up-to-date with the FDA and other regulatory agencies regarding applications of electronic, patient-level databases and other emerging epidemiologic research tools. Exploring and developing new methodologies will be encouraged as will participation in external public-private partnerships with the aim of enhancing medical device safety capabilities. Work will also include, through existing databases and other tools, such as registries, researching natural history of diseases to understand the inherent risks associated with the indications for devices; statistical risk assessment; using clinical and non-clinical data sources to develop an understanding of potential safety issues for new devices and new indications; and planning and conducting systematic reviews of the literature and/or meta-analyses of safety data from various sources.
Qualifications
An advanced degree in epidemiology or related field is required, with a PhD, ScD, or MD with training and degree in epidemiology or related field (such as health economics, outcomes research) highly preferred. A minimum 7 years of epidemiology or related research experience in health care is also required. Pharmaceutical or medical device industry experience is highly preferred. A sophisticated understanding and the ability to interpret quantitative methods are required. Experience with writing Methods sections of study proposals/ protocols/ proposal requests or background epidemiologic material on specific disease or therapeutic areas is also required. Ability to perform duties in terms of stated objectives under general or minimum supervision. Proven leadership skills; ability to thrive in a global, matrix environment is required. Ability to influence, negotiate and communicate with both internal and external customers is required. Ability to develop, implement, communicate, and influence policy and strategy internally and externally to the company is required. Excellent verbal and written communication skills, including formal presentation skills are required. Strong collaborative and networking skills are required. There will be up to 20% Travel. This position will be based in New Brunswick, NJ.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. Johnson & Johnson companies are equal opportunity employers.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
Primary Location:North America-United States-New Jersey-Bridgewater
Organization: MD&D Global Services LLC (6209)
Job Function: Epidemiology
Relocation: Eligible No
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement