Johnson & Johnson
Principal Medical Sciences Specialist - Shockwave Medical
Johnson & Johnson, Santa Clara, California, us, 95053
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Johnson & Johnson is hiring for a
Principal Medical Sciences Specialist – Shockwave Medical
to join our team. The position is
FULLY REMOTE
and can sit anywhere in the US. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview
The Principal Medical Sciences Specialist is an integral member of the Medical Affairs team that will serve as a two-way scientific exchange resource to internal and external stakeholders by accurately communicating real-time, specific and balanced product and disease information through the on-going critical evaluation of clinical and scientific information while adhering to legal, compliance and regulatory requirements. The Principal Medical Sciences Specialist will be hands-on and is expected to be an expert scientific resource and apply sound principles in researching, acquiring, assessing, and synthesizing the scientific merit and relevancy of clinical data. Essential Job Functions
Develop and maintain a high level of expertise on Shockwave Medical clinical evidence / data and competitive technologies. Lead the periodic review of clinical reports, abstracts, manuscripts, and other materials related to scientific data and information to ensure data are represented accurately. Support the creation of scientific content, including conference reports, data summaries, disease state overviews, white papers etc. Establish and maintain strong internal cross-functional and external key opinion leader relationships. Drive ad-hoc/post-hoc data analyses and plan the execution of such analyses in collaboration with Clinical Affairs and Biostats partners. Collaborate with the Medical Information team to drive accurate and timely delivery of scientific information to cross-functional team members and external health care providers (HCPs). Support market access, dossier/tender and unsolicited scientific on- and off-label requests for information, linking Shockwave Medical scientific data to real-world clinical practice to meet customer needs. Support the development of clinical documents, including study protocols, case report forms, instructions for use, clinical study reports, and regulatory submissions. As needed, assist in the Medical Affairs review of advertising/promotional/education material. Support the Clinical Evaluation Process as appropriate. May support / conduct data extraction from scientific publications and provide analysis. May support the development of physician CME presentations to support evidence dissemination in the medical community. May mentor and train other members of the Medical Sciences Team. Other duties as needed. Requirements
Minimum Master’s degree in a scientific field with a minimum of 8 years of relevant Medical Affairs experience in the Medical Device Industry. Advanced degree preferred (PhD, MD). Medical Affairs experience at a cardiovascular medical device company preferred. Knowledge of FDA and international regulations, including, but not limited to medical product communications and response to unsolicited requests for off-label information. Works effectively on cross-functional teams. Ability and knowledge in researching, verifying, and correctly assessing, summarizing, and citing clinical and scientific information and data sources. Demonstrated effective written and verbal skills across various audiences. Operate as a team or independently while maintaining flexibility and resilience. Demonstrated willingness to take responsibility for projects and tasks. Statistical analysis knowledge preferred. High attention to detail and accuracy. Excellent prioritization and organizational skills. Excellent critical thinking skills. Ability to work in a fast-paced environment while managing multiple priorities. Ability to travel up to 50% of the time, including potential international travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. The anticipated base pay range for this position is: US : $105,000 - $169,050 / Bay Area : $121,000 - $194,350.
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Principal Medical Sciences Specialist – Shockwave Medical
to join our team. The position is
FULLY REMOTE
and can sit anywhere in the US. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview
The Principal Medical Sciences Specialist is an integral member of the Medical Affairs team that will serve as a two-way scientific exchange resource to internal and external stakeholders by accurately communicating real-time, specific and balanced product and disease information through the on-going critical evaluation of clinical and scientific information while adhering to legal, compliance and regulatory requirements. The Principal Medical Sciences Specialist will be hands-on and is expected to be an expert scientific resource and apply sound principles in researching, acquiring, assessing, and synthesizing the scientific merit and relevancy of clinical data. Essential Job Functions
Develop and maintain a high level of expertise on Shockwave Medical clinical evidence / data and competitive technologies. Lead the periodic review of clinical reports, abstracts, manuscripts, and other materials related to scientific data and information to ensure data are represented accurately. Support the creation of scientific content, including conference reports, data summaries, disease state overviews, white papers etc. Establish and maintain strong internal cross-functional and external key opinion leader relationships. Drive ad-hoc/post-hoc data analyses and plan the execution of such analyses in collaboration with Clinical Affairs and Biostats partners. Collaborate with the Medical Information team to drive accurate and timely delivery of scientific information to cross-functional team members and external health care providers (HCPs). Support market access, dossier/tender and unsolicited scientific on- and off-label requests for information, linking Shockwave Medical scientific data to real-world clinical practice to meet customer needs. Support the development of clinical documents, including study protocols, case report forms, instructions for use, clinical study reports, and regulatory submissions. As needed, assist in the Medical Affairs review of advertising/promotional/education material. Support the Clinical Evaluation Process as appropriate. May support / conduct data extraction from scientific publications and provide analysis. May support the development of physician CME presentations to support evidence dissemination in the medical community. May mentor and train other members of the Medical Sciences Team. Other duties as needed. Requirements
Minimum Master’s degree in a scientific field with a minimum of 8 years of relevant Medical Affairs experience in the Medical Device Industry. Advanced degree preferred (PhD, MD). Medical Affairs experience at a cardiovascular medical device company preferred. Knowledge of FDA and international regulations, including, but not limited to medical product communications and response to unsolicited requests for off-label information. Works effectively on cross-functional teams. Ability and knowledge in researching, verifying, and correctly assessing, summarizing, and citing clinical and scientific information and data sources. Demonstrated effective written and verbal skills across various audiences. Operate as a team or independently while maintaining flexibility and resilience. Demonstrated willingness to take responsibility for projects and tasks. Statistical analysis knowledge preferred. High attention to detail and accuracy. Excellent prioritization and organizational skills. Excellent critical thinking skills. Ability to work in a fast-paced environment while managing multiple priorities. Ability to travel up to 50% of the time, including potential international travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. The anticipated base pay range for this position is: US : $105,000 - $169,050 / Bay Area : $121,000 - $194,350.
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