Associate Manager, Global Regulatory Submissions-1421064W
Description
THE COMPANY AND CULTURE
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. 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.
With $71.3 billion in 2013 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 127,000 people in 60 countries throughout the world.
ASSOCIATE MANAGER, GLOBAL REGULATORY SUBMISSIONS
Center for Global Safety & Consumer Pharmacovigilance Operations
JOB SUMMARY
This role is to provide regulatory expertise in the evaluation of individual case safety reports for submission from a variety of sources as part of the overall Pharmacovigilance process. The Regulatory Submissions Manager has primary responsibility for overseeing the determination of the accuracy of submission to the various health authorities. These responsibilities include overseeing submission of spontaneous reports, clinical and non-clinical studies, literature reports and other sources of data.
Qualifications
EDUCATIONAL REQUIREMENT AND OTHER SKILLS REQUIRED
-
RN or BS degree in health related field, PhD/PharmD or other related scientific degree/qualification
-
For nurses and pharmacists, certification/licensure is preferred (e.g. RN, RPh, PharmD)
-
Previous industry and/or experience with focus on pharmaceutical safety related areas, including individual and aggregate reports preferred
Primary Location:Asia Pacific-Philippines-National Capital-Manila
Organization: Johnson & Johnson International (Singapore) Pte. Ltd. - ROHQ
Job Function: R&D
Description
THE COMPANY AND CULTURE
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. 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.
With $71.3 billion in 2013 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 127,000 people in 60 countries throughout the world.
ASSOCIATE MANAGER, GLOBAL REGULATORY SUBMISSIONS
Center for Global Safety & Consumer Pharmacovigilance Operations
JOB SUMMARY
This role is to provide regulatory expertise in the evaluation of individual case safety reports for submission from a variety of sources as part of the overall Pharmacovigilance process. The Regulatory Submissions Manager has primary responsibility for overseeing the determination of the accuracy of submission to the various health authorities. These responsibilities include overseeing submission of spontaneous reports, clinical and non-clinical studies, literature reports and other sources of data.
Qualifications
EDUCATIONAL REQUIREMENT AND OTHER SKILLS REQUIRED
-
RN or BS degree in health related field, PhD/PharmD or other related scientific degree/qualification
-
For nurses and pharmacists, certification/licensure is preferred (e.g. RN, RPh, PharmD)
-
Previous industry and/or experience with focus on pharmaceutical safety related areas, including individual and aggregate reports preferred
Primary Location:Asia Pacific-Philippines-National Capital-Manila
Organization: Johnson & Johnson International (Singapore) Pte. Ltd. - ROHQ
Job Function: R&D