Clinical Research Scientist JJMT Electrophysiology

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 Summary:

This professional will report to Clinical Science and External Research (CSER) Leaders in the management of assigned clinical projects for the Cardiovascular Group to support the development of the evidence generation and dissemination strategy of assigned products manage clinical studies execute publication plans and conduct literature reviews. S/he will manage activities with supervision consistent with level of experience. S/he will be responsible for providing support activities for clinical activities and other study-related tasks as well as applicable department study-related procedures.

Key Responsibilities:

The Clinical Research Scientist will or may be responsible for:

• End to end support for external research collaborations: (i) planning and executing research collaborations with physicians (ii) tracking study idea development and progress and (iii) planning data dissemination via congress presentation and peer-reviewed publications
• Managing nonregulated studies (eg Investigator initiated Registries Real-world evidence Company -sponsored postmarket studies) and low complexity regulated studies (eg Postapproval Real-world evidence) including study budget assessment fair market value appraisal contract development and execution and payments
• Interfacing and collaborating with investigators IRBs/ECs Competent Authorities contractors/vendors and Company personnel
• Developing study-related materials (eg protocol CRFs CSR)
• Analyzing interpreting summarizing and sharing appropriate interpretation of clinical evidence generated from research studies
• Leading study-related publication efforts including abstracts congress presentations and manuscripts per clinical publication policy
• Collaborating with cross-functional team members to develop collaterals to disseminate research results among internal and external stakeholders
• Knowing understanding incorporating and complying with all applicable laws and regulations relating to business activities and Policies and Procedures
• Evaluating publication support requests and providing meaningful consolidated comments during the publication development lifecycle
• Tracking assigned project budgets to ensure adherence to business plans
• Communicating progress towards planned timelines

Qualifications:

• A minimum of a Bachelors degree with at least 5 years of clinical research experience required
• Advance degree (Masters degree PhD PharmD etc.) with 2-3 year of clinical or related research experience highly preferred
• A Life Science Physical Science Nursing or Biological Science degree is preferred
• Ability to analyze and interpret scientific data and advanced writing/presentation skills are required such as conducting literature reviews and planning and drafting conference presentation and peer-reviewed journal articles
• Knowledge of Good Clinical Practices and ICJME/Good Publication Practices is required
• Gpp3 ISMPEE highly preferred
• Good understanding of clinical research science and processes along with an understanding of product development processes team dynamics related to healthcare market environment and global clinical trial regulations is preferred
• Prior experience designing and executing clinical studies is highly desirable
• Project management skills with the ability to handle multiple projects is required
• Medical device experience is preferred
• Cardiovascular experience is a plus
• Relevant industry certifications preferred (ie CCRA RAC CDE CMPP MWC)
• This position is located in Irvine CA

Additional Skills Requirements:

• Effective time management organizational and prioritization skills and the ability to manage multiple tasks
• Strong project management skills with meticulous attention to detail and accuracy
• Professional verbal and written communication skills
• Able to discuss research ideas with external research partners
• Proven ability to collaborate in a cross-functional team environment while having the skillset and confidence to work independently as needed
• 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 CSER goals and objectives
• Proficient in Microsoft Office

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 and 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 email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: