Biosense Webster Inc. is recruiting a Manager, Clinical Science & External Research (Scientific Communications) located in Irvine, California. This role will work a hybrid schedule and must live within a commutable distance to Irvine, CA to report to the office on assigned days 2-3 times per week.
The Manager, Clinical Science & External Research (CSER) will be responsible for leading and developing internal and external scientific communication contents for assigned projects. We are looking for someone with high standards of scientific analysis, teamwork, creative thinking, and interpersonal skills for the advancement of clinical programs via evidence generation and dissemination. You will collaborate closely with a cross-functional team, including Scientific Affairs, R&D, Health Economics, Marketing, and Education to conduct literature reviews and gap analyses, lead strategic analysis of scientific data, craft and implement comprehensive publication plans, and support internal and external scientific communication plans for various target audiences. In collaboration with cross-functional teams and research investigators, you will generate clinically relevant evidence for the company's innovative pipeline that impacts patient lives. You will be joining a growing function that drives research innovations! This role will have broad reach and visibility with the Company.
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You should possess advanced understanding and maintain current knowledge of industry standards on scientific communication and publication development. You will demonstrate understanding of the disease area, develop a keen understanding of the Operating Company product portfolio and clinical strategies to provide strategic input to publication planning & evidence generation and dissemination strategies. We are looking for a highly motivated and independent individual with abilities to problem solve and run projects effectively. You are expected to provide quality feedback and keep management informed of key developments and issues related to your projects.
You will understand, incorporate, and follow all applicable laws and regulations related to business activities, and Policies and Procedures of Healthcare Compliance and Code of conduct. You will serve as an internal subject matter expert on guidelines governing the ethical publication of clinical study data, including mastering the guidelines set forth by the International Committee of Medical Journal Editors and Good Publication Practices, and applicable policies governing compliant scientific communications.
You may be asked to provide training for employees, as needed. Additionally, you may support associates that handle a variety of clinical studies (investigator Initiated, registries, real-world evidence or company sponsored post-market studies/premarket collaborative studies) that collectively drive the generation of clinical evidence for the Company's portfolio.
You will consistently strive to improve the performance, reputation, and image of the team and ensure efficient use of resources to provide high quality deliverables.
Key Responsibilities:
- Leads evidence generation and dissemination strategy for assigned products
- Conducts literature searches and gap analyses to identify evidence gaps used to inform evidence generation and publication plans
- Develops and implements comprehensive publication plans
- Drives impactful publication development (ie, congress presentations, peer-reviewed articles) cross-functionally with Clinical Research, Biostatistics and physician authors
- Provides critical scientific input during publication lifecycle from outline development to galley proof approval
- Engages with cross-functional teams to develop and implement training and dissemination plans for scientific communication materials tailored to various internal and external audiences
- Handles budget, and supervises contracts and vendors associated with publication and communication strategy execution
- Supports congress planning, including leading clinical booth activities and scientific evidence gathering
- Provides input to Company-sponsored, collaborative studies, and investigator-initiated studies, as needed
- Mentors junior CSER staff
Qualifications
Qualifications
Required:
• A minimum of a Bachelor's Degree in Life Sciences, Physical Science, Nursing, Biological Science, or closely related field
• A minimum of 5+ years of evidence generation and dissemination experience in a relevant clinical or medical affairs industry setting
• Strong project management skills with the ability to balance multiple projects
• Able to influence others
• Strong written and oral communication skills
• Strategic mentality and critical analytical skill
• Leadership in evidence generation strategy
• Proven success in publication planning, development, and execution
• Experience supervising medical writers and personnel developing evidence dissemination collaterals for a variety of audiences
• Knowledge of Good Clinical Practices and ICMJE standards
Preferred:
• PhD/MD/PharmD with industry/academic research experience
• 8+ years of clinical, medical affairs, or related industry setting technical experience
• 3+ years of medical device experience, especially in cardiovascular and/or electrophysiology therapeutic areas
• Experience training internal and personnel on clinical evidence supporting medical device products
• ISMPP CMPP™ or AMWA MWC® credentials
Other:
• May require up to 15% travel.
At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
The anticipated base pay range for this position is 113,000 to 195,500.
This job posting is anticipated to close on September 27, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.