Clinical Communications Analyst - IDAR Experienced Engineer

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 ;br>
Job Function:
R&D Product Development

Job Sub Function:
R&D Digital

Job Category:
Scientific/Technology

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at ;br>
We are searching for the best talent for an Experienced Engineer to be in Springhouse, PA; Malvern, PA; Horsham, PA or Titusville, NJ.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

The Experienced Engineer I, II, Enabling Analytics & System Excellence (EASE) will provide support in the planning, administration and oversight of clinical systems and related processes administered by EASE within Investigator & Patient Solutions (I&PS). Under general supervision, this role executes plans that innovate product development, meet organization standards, and follow digital strategy. This role is a liaison between the business community and key partners and stakeholders. The Experienced Engineer I, II, EASE supports the enhancement and optimization of capabilities and processes, fostering collaboration to drive strategy, efficiency and quality across J&J systems and development initiatives.

As an Experienced Engineer, you will be responsible for:

• Experience in Clinical Trials: Proven track record of managing and supporting clinical trial teams and coordinating tool delivery effectively.
• Collaboration Skills: Strong ability to work with diverse teams, including vendors and study partners, to ensure timely delivery of solutions and initiatives.
• End User Support Skills: Experience in providing technical support through various channels, including ticketing systems and mailboxes.
• System Release Management: Lead/contribute to UAT testing and facilitate support for system improvements and integrations.
• Training Material Development: Ability to create and update training materials, as well as present to user groups to encourage system compliance.
• Analytical Skills: Proficiency in preparing reports on tool usage, effectiveness, and providing valuable insights for leadership.
• Continuous Improvement Mindset: Engage in discussions with stakeholders to identify improvement opportunities using data analysis and new technologies.
• Project Management Experience: Capable of managing smaller-scale projects and participating in cross-functional initiatives.
• Regulatory Compliance Knowledge: Deep knowledge of SOPs and regulatory requirements to ensure study alignment and audit support.
• Leadership and Communication Skills: Ability to lead cross-functional projects, provide regular updates, and escalate issues as necessary.
• Process Development Experience: Experience in creating and maintaining guidance materials and standard operating procedures.
• Resource Strategy Implementation: Skills in planning, scheduling, and hosting training sessions for teams, aligning resources with strategic goals.

Principal Relationships:

• Internal: Global Development Study Teams and Functional Areas; IT; R&D Quality; MedTech; J&J Legal.
• External: System Vendors; Investigator Site Staff; CRO points of contact; Regulatory Inspectors; Industry Peer Networks

Education and Experience Requirements:

• A minimum of a bachelor's degree or equivalent is required, preferably in Health, Science, Information Technology or another relevant field.
• A minimum of 3 years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company and/or a Clinical Research Organization (CRO) is required.
• Experience working with IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration is required. Experience with direct support of IT systems and related processes that support clinical development is preferred.
• Knowledge of the drug development process, including Good Clinical Practices (Google Cloud Platforms) and FDA Code of Federal Regulations, is required.
• Excellent analytical, problem solving, communication and presentation skills.

Other:

• Ability to travel up to 10% of the time (Domestic/International) is required.
• Ability to communicate effectively in English.
• Global business mindset.

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.