Senior Engineer, R&D Digital
About the role
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Job Description
About Innovative Medicine
You will be responsible for
- Identifying and implementing technology improvements that optimize CTM Solutions systems and processes and deliver measurable value.
- Assessing study-team needs and translate them into practical system and process solutions.
- Supporting study build, maintenance, and effective system use throughout the study lifecycle.
- Providing end-user support through service tickets and shared mailboxes, ensuring timely follow-up and resolution.
- Identifying and supporting opportunities to improve workflows through automation, analytics, and GenAI capabilities, while following applicable privacy, security, quality, compliance, and human oversight requirements.
- Coordinating release management, user acceptance testing, system improvements, and integrations with IT, system owners, and suppliers.
- Troubleshooting advanced system and process issues in collaboration with IT and vendors.
- Creating and delivering training, guidance, and reference materials that enable effective system and process use.
- Facilitating team meetings and contribute to cross-functional projects.
- Supporting system and process audits, regulatory inspections, and corrective and preventive actions.
Qualifications / Requirements
- Minimum of a Bachelor's degree is required, preferably in Health, Science, Information Technology or another relevant field.
- Minimum of 5 years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company and/or a Clinical Research Organization (CRO) is required.
- Proficiency supporting IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration is required.
- Solid understanding of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations is required.
- The ability to partner and influence people at all levels of the organization is required.
- Superior communication, business partnering, problem solving, and prioritization skills is required.
- Global business mindset is required.
- Ability to travel up to 10% of the time (Domestic/International) is required.
- Project Management or Process Improvement certification is preferred.
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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check.
Preferred Skills
The anticipated base pay range for this position is
Not included in the source posting: benefits.
Skills
Who can apply
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