Senior Manager, Medical Affairs- Shockwave Medical

Johnson & Johnson • Santa Clara, CA

7d • Remote

About The Position

Johnson & Johnson is hiring for a Senior Manager, Medical Affairs– Shockwave Medical to join our team. 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. 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. Learn more at https://www.jnj.com/. 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.

Requirements

• Master’s degree in a scientific field with a minimum of 10 years of relevant Medical Affairs experience in the Medical Device Industry.
• Knowledge of FDA and international regulations, including, but not limited to, evidence strategy and planning, scientific communications, KOL interactions and / or medical product communications/response to unsolicited requests for off-label information.
• Works effectively on cross-functional teams and within medical affairs.
• Ability and knowledge in researching, verifying, and correctly assessing, summarizing, and citing clinical and scientific information and data sources.
• Demonstrated effective people management experience.
• 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.
• High attention to detail and accuracy.
• Good prioritization and organizational skills.
• Excellent critical thinking skills.
• Ability to work in a fast-paced environment while managing multiple priorities and team.
• Ability to travel up to 50% of the time, including potential international travel.

Nice To Haves

• Advanced degree preferred (PhD, MD).
• Medical Affairs experience at a cardiovascular medical device company preferred.
• Statistical analysis knowledge preferred.

Responsibilities

• Develop and maintain a high level of expertise on Shockwave Medical clinical evidence / data and competitive technologies.
• Drive the evidence strategy and/or the evidence dissemination process for the Shockwave Medical Portfolio.
• Support cross-functional product development and/or clinical evidence teams as the Medical Affairs representative.
• Participate in the periodic review of clinical reports, abstracts, manuscripts, and other materials related to scientific data and information to ensure data are represented accurately.
• Be an integral Medical Affairs member in the creation of scientific content, including abstracts, manuscripts, scientific podium presentation, conference reports, data summaries, disease state overviews, white papers etc.
• Establish and maintain strong internal cross-functional (i.e. Clinical Affairs, Medical Affairs, Biostats, R&D, Upstream marketing/business development, Commercial Marketing and Sales) and external key opinion leader relationships.
• Drive and/or lead 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.
• Be on the leadership team of the Director, Medical Affairs.
• Other duties as needed.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior