Medical Affairs Scientist, Structural Heart (Irvine, CA) Johnson and Johnson MedTech, Electrophysiology Full-time

Medical Affairs Scientist, Structural Heart

Johnson & Johnson MedTech Electrophysiology is recruiting for a Medical Affairs Scientist, Structural Heart to join our team in Irvine, CA.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness.

Role Purpose

The Medical Affairs Scientist, Structural Heart will provide insights through literature and support the execution of company sponsored clinical trials and product evidentiary needs for safety and effectiveness assessments. This role will collaborate with R&D, Strategic Marketing, and Clinical Affairs to uncover insights on clinical and technology gaps and evidence that supports marketing messages through systematic reviews and meta-analyses, and strive to publish in peer-reviewed journals. In addition, the role will assist the study medical lead for clinical studies in adjudication of adverse events and concomitant medications. This position will require an individual with passion for scientific research.

What you will be doing:

• Perform scientific exploration including systematic reviews, meta-analyses, and literature analysis for research questions identified to understand clinical and technological gaps, device evidence, or disease state reviews.
• Write and publish peer-reviewed pieces including abstracts, posters, and articles. Possibility to present at conferences.
• Provide insights to collaborating functions including Research and Development (R&D), Global Strategic Marketing (GSM), Health Economics and Market Access (HEMA), and Clinical Affairs (CA).
• Support the recruitment and mentoring of interns that are typically 6-9 months long to increase scientific content exploration and publication.
• Provide support to study medical lead for company sponsored clinical studies, supporting the clinical trial team to execute on the study in a safe, effective, and timely manner.
• Contribute towards development and approval of clinical trial protocols, informed consents, investigator brochures, committee charters, and other study materials.
• Conduct routine review of adverse events (AEs), medical coding, source documents, and subject narratives.
• Contribute to drafting and review of study reports for assigned studies to include annual reports (APR), study close out reports (CSR) as well as other regulatory submissions
• Support the evidence needs of technical documentation from a scientific perspective for new products in development and in lifecycle management.
• Provide informed scientific input during study team meetings
• Support the generation of the preclinical & clinical evidence strategies to support clinical claims and participating in characterizing the product's capabilities and clinical workflows in collaboration with Marketing, R&D, and other development team members.
• Support early product introduction to the market supporting launches as well as internal & external training
• Ability and willingness to travel up to 25% of the time
• Perform other duties assigned as needed

Qualifications – External

What you will bring:

• A degree in science, engineering, or medicine is required. Master of Science or PhD are preferred.
• Structural heart interventions experience.
• Demonstrated experience in scientific research, publications, and presentations.

Experience and Skills:

• A minimum of 2 years of clinical, engineering or life science experience is required.
• Structural heart interventions experience is required.
• Ability to understand, interpret and communicate sophisticated scientific and medical information to diverse audiences.
• Previous experience working with Medical/Clinical/R&D teams in a highly regulated, matrixed commercial medical device business is preferred.
• Strong interpersonal and scientific communication skills (written and verbal).
• Self-starter with proven ability to collaborate in a cross-functional team environment while having the skillset and confidence to work independently, as needed
• Project management skills with the ability to handle multiple projects
• Effective time management, organizational and prioritization skills, and the ability to manage multiple tasks
• Must be reliable, and flexible in adapting to shifting business needs while contributing to a multidisciplinary and fast-paced working environment
• Must be a highly motivated, responsible, fast-learner, and team-oriented collaborator willing to take ownership of his/her contributions to the advancement of the collective team goals and objectives
• Proficient in Microsoft Office

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be 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.
• Employees are eligible for the following time off benefits:
  • Vacation – up to 120 hours per calendar year
  • Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays – up to 13 days per calendar year
  • Work, Personal and Family Time – up to 40 hours per calendar year

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $105,000 to $169,050