Op Sp Patient Site Engagement

Johnson & Johnson•Spring House, PA

12d

About The Position

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 https://www.jnj.com/ . About Innovative Medicine 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 https://www.jnj.com/innovative-medicine An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Ops Sp Patient & Site Engagement. The Patient & Site Engagement (PSE) Operations Specialist serves as the primary contact for trial teams, responsible for managing, executing, and delivering patient and site-facing initiatives in support of clinical trials. This role involves interfacing with key stakeholders within the Global Development Organization (GD), including Trial Delivery Leader (TDL), Clinical Trial Managers (CTM), Local Trial Managers (LTM), and Site Managers (SM), as well as external suppliers and other relevant stakeholders.

Requirements

A Bachelor’s Degree or equivalent and prerably in the scientific or health-related discipline.
At least 3 years of relevant work experience in global patient recruitment and clinical trial execution with a pharmaceutical company, CRO, or healthcare facility/research site.
Expertise in drug development, clinical trial operations, and strategic planning.
Previous experience in clinical trial operations, including executing study outreach, patient compliance, and support programs.
Strong planning, tracking, customer focus, organization, and detail-oriented skills, capable of managing multiple projects successfully.
Excellent time management, prioritization, and self-management skills, with strong project management capabilities.
A strong team orientation, demonstrating initiative to solve problems and improve efficiency and customer service.
High proficiency in Microsoft Excel, PowerPoint, Word, and Microsoft Project.
Strong written and oral communication skills, with a good understanding of relevant software and company systems.
Willingness to travel as needed.

Nice To Haves

Agility Jumps
Business Alignment
Collaborating
Communication
Continuous Improvement
Execution Focus
Problem Solving
Process Improvements
Project Management Methodology (PMM)
Project Management Office (PMO)
Project Reporting
Project Schedule
Quality Control (QC)
Report Writing
Research and Development
Stakeholder Engagement

Responsibilities

Ensure that executed strategies meet compliance guidelines and are delivered on time and within budget.
Work with the PSE Manager to ensure program- and trial-level PSE deliverables are completed on schedule.
Maintain a comprehensive library of tools and tactics in the virtual Trial Master File (vTMF), ensuring effective documentation of business processes and quality standards for tactic development.
Document updates to the program- and trial-level PSE strategy, including the study overview deck.
Adhere to Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, and maintain compliance with relevant time reporting systems and training requirements.
Accurately oversee the Scope of Work (SOW) for External Service Providers, managing PSE trial budgets and Purchase Orders proactively.
Keep the project plan updated regarding timelines and budgets, aligned with the SOW for the delivery of tools and tactics for clinical trials.
Drive the execution of tactics and initiatives through the management of service providers, including creative content development, global translations, material production, and the technical development of apps and websites to enhance patient/caregiver and site engagement.
Support the PSE Manager in vendor activities such as budget tracking, filing, training, eMP requests, and issue logging.
Document compliance reviews and approvals of tools and tactics, maintaining oversight for Institutional Review Board (IRB)/Ethics Committee (EC) approvals as needed.
Facilitate clear communication with all stakeholders to ensure defined expectations, contributing to study meetings through facilitation, attendance, or presentation.
Maintain a deep understanding and proficiency in finance and contracting systems relevant to the role.
Ensure the delivery of presentations and workshop content at International Investigator Meetings, Ad Hoc face-to-face meetings, and similar engagements.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 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