Job Function: Medical Affairs Group
Job Sub Function: Medical Affairs
Job Category:People Leader
All Job Posting Locations:Santa Clara, California, United States of America
Job Description: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.
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 OverviewThe Sr. Manager, Medical Affairs is an integral member of the Medical Affairs team that will serve as a two-way scientific exchange resource to internal (i.e. Clinical Affairs, Medical Affairs, Biostats, Marketing, R&D etc.) and external (i.e. HCPs) 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 Sr. Manager, Medical Affairs 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.
- 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.
Qualifications- Master's degree in a scientific field with a minimum of 10 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, 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.
- Statistical analysis knowledge preferred.
- 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.
Required Skills:Preferred Skills:Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Content Evaluation, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Prioritization of Tasks, Product Strategies, Scientific Research, Strategic Thinking, Team Management
The anticipated base pay range for this position is :$157,000.00 - $271,400.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
