Johnson & Johnson MedTech
Principal Medical Sciences Specialist - Shockwave Medical
Johnson & Johnson MedTech, Santa Clara, California, us, 95053
Overview
Principal Medical Sciences Specialist – Shockwave Medical role at Johnson & Johnson MedTech. The position is FULLY REMOTE and can sit anywhere in the US. 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. Learn more at https://www.jnj.com/. 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 (e.g., Clinical Affairs, Medical Affairs, Biostats, Marketing, R&D) and external (e.g., HCPs) stakeholders. The role involves accurately communicating real-time, specific and balanced product and disease information through ongoing critical evaluation of clinical and scientific information while adhering to legal, compliance and regulatory requirements. The Specialist will be hands-on and is expected to be an expert scientific resource, applying 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 to ensure accurate representation. Support the creation of scientific content (internal use and regulatory submissions), including conference reports, data summaries, disease state overviews, white papers, etc. Establish and maintain strong internal cross-functional and external KOL 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 deliver accurate and timely scientific information to cross-functional team members and external healthcare providers (HCPs). Support market access, dossier/tender and unsolicited scientific on- and off-label information requests, linking Shockwave Medical data to real-world practice. Support development of clinical documents, including study protocols, case report forms, instructions for use, clinical study reports, and regulatory submissions. Assist in the Medical Affairs review of advertising/promotional/educational material as needed. Support the Clinical Evaluation Process as appropriate. May support data extraction from scientific publications and provide analysis. May support the development of physician CME presentations for evidence dissemination. May mentor and train other members of the Medical Sciences Team. Other duties as needed. Qualifications
Minimum Master’s degree in a scientific field with at least 8 years of relevant Medical Affairs experience in the Medical Device Industry. Advanced degree (PhD, MD) preferred. Medical Affairs experience at a cardiovascular medical device company preferred. Knowledge of FDA and international regulations related to medical product communications and responses to unsolicited off-label information requests. Ability to work effectively on cross-functional teams. Strong ability to research, verify, and correctly assess, summarize, and cite clinical and scientific information and data sources. Excellent written and verbal communication skills across diverse audiences. Ability to work independently or in a team, with flexibility and resilience. Willingness to take responsibility for projects and tasks. Statistical analysis knowledge preferred. High attention to detail and accuracy; strong prioritization and organizational skills; critical thinking. 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. Compensation and Benefits
The anticipated base pay range for this position is: US $105,000 - $169,050; Bay Area US $121,000 - $194,350. Employees may participate in company-sponsored benefits programs (medical, dental, vision, life, disability, etc.), retirement plans, and other programs as described in company policies. This position is eligible for the company’s long-term incentive program and time-off benefits as outlined in the policies. 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 law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under applicable laws. Locations
Santa Clara, California, United States of America
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Principal Medical Sciences Specialist – Shockwave Medical role at Johnson & Johnson MedTech. The position is FULLY REMOTE and can sit anywhere in the US. 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. Learn more at https://www.jnj.com/. 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 (e.g., Clinical Affairs, Medical Affairs, Biostats, Marketing, R&D) and external (e.g., HCPs) stakeholders. The role involves accurately communicating real-time, specific and balanced product and disease information through ongoing critical evaluation of clinical and scientific information while adhering to legal, compliance and regulatory requirements. The Specialist will be hands-on and is expected to be an expert scientific resource, applying 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 to ensure accurate representation. Support the creation of scientific content (internal use and regulatory submissions), including conference reports, data summaries, disease state overviews, white papers, etc. Establish and maintain strong internal cross-functional and external KOL 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 deliver accurate and timely scientific information to cross-functional team members and external healthcare providers (HCPs). Support market access, dossier/tender and unsolicited scientific on- and off-label information requests, linking Shockwave Medical data to real-world practice. Support development of clinical documents, including study protocols, case report forms, instructions for use, clinical study reports, and regulatory submissions. Assist in the Medical Affairs review of advertising/promotional/educational material as needed. Support the Clinical Evaluation Process as appropriate. May support data extraction from scientific publications and provide analysis. May support the development of physician CME presentations for evidence dissemination. May mentor and train other members of the Medical Sciences Team. Other duties as needed. Qualifications
Minimum Master’s degree in a scientific field with at least 8 years of relevant Medical Affairs experience in the Medical Device Industry. Advanced degree (PhD, MD) preferred. Medical Affairs experience at a cardiovascular medical device company preferred. Knowledge of FDA and international regulations related to medical product communications and responses to unsolicited off-label information requests. Ability to work effectively on cross-functional teams. Strong ability to research, verify, and correctly assess, summarize, and cite clinical and scientific information and data sources. Excellent written and verbal communication skills across diverse audiences. Ability to work independently or in a team, with flexibility and resilience. Willingness to take responsibility for projects and tasks. Statistical analysis knowledge preferred. High attention to detail and accuracy; strong prioritization and organizational skills; critical thinking. 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. Compensation and Benefits
The anticipated base pay range for this position is: US $105,000 - $169,050; Bay Area US $121,000 - $194,350. Employees may participate in company-sponsored benefits programs (medical, dental, vision, life, disability, etc.), retirement plans, and other programs as described in company policies. This position is eligible for the company’s long-term incentive program and time-off benefits as outlined in the policies. 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 law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under applicable laws. Locations
Santa Clara, California, United States of America
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