Senior Engineer, R&D Digital

Johnson & Johnson•Horsham, PA

7d•Hybrid

About The Position

The Senior Engineer, R&D Digital provides expertise and executes plans for Clinical Trial Management Solutions (CTM Solutions) systems and processes. The role supports clinical-trial study management and oversight capabilities, including CTMS, Site Payments, and Access Provisioning. Under general direction, the Senior Engineer executes plans and processes that support product development, meet organizational standards, and align with digital strategy. The role serves as a liaison between the business community and key partners and stakeholders, collaborating with business partners, IT, and suppliers. The position contributes to customer enablement, metrics, user administration and support, system integrations, continuous improvement, and change management. It is based in Horsham or Spring House, Pennsylvania, or Raritan, New Jersey, and requires up to 10% domestic or international travel.

Requirements

Bachelor’s degree, preferably in Health, Science, Information Technology, or another relevant field.
At least 5 years of relevant experience in clinical trial execution with a pharmaceutical or medical device company and/or a Clinical Research Organization (CRO).
Proficiency supporting IT systems and related processes for clinical development, reporting tools, Office 365 applications, and database administration.
Solid understanding of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations.
Ability to partner with and influence people at all levels of the organization.
Superior communication, business partnering, problem-solving, and prioritization skills.
Global business mindset.
Ability to travel up to 10% of the time, domestically and internationally.

Nice To Haves

Project Management or Process Improvement certification.

Responsibilities

Identify and implement technology improvements that optimize CTM Solutions systems and processes and deliver measurable value.
Assess study-team needs and translate them into practical system and process solutions.
Support study build, maintenance, and effective system use throughout the study lifecycle.
Provide end-user support through service tickets and shared mailboxes, with timely follow-up and resolution.
Identify and support workflow improvement opportunities through automation, analytics, and GenAI, following applicable privacy, security, quality, compliance, and human-oversight requirements.
Coordinate release management, user acceptance testing, system improvements, and integrations with IT, system owners, and suppliers.
Troubleshoot advanced system and process issues with IT and vendors.
Create and deliver training, guidance, and reference materials to enable effective system and process use.
Facilitate team meetings and contribute to cross-functional projects.
Support system and process audits, regulatory inspections, and corrective and preventive actions.

Benefits

Consolidated retirement plan (pension) and savings plan (401(k)), subject to the terms of the plans.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with specified state-based amounts for Colorado and Washington employees.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental Leave: 480 hours within one year of the birth, adoption, or foster care of a child.
Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.