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At Johnson & Johnson, we use technology and the power of teamwork to discover new ways to prevent and overcome the world's the most significant healthcare challenges. Our Corporate, MedTech, and Pharmaceutical teams leverage data, real-world insights, and creative minds to make life-changing healthcare products and medicines. We're disrupting outdated healthcare ecosystems and infusing them with transformative ideas to help people thrive throughout every stage of their lives. With a reach of more than a billion people every day, there's no limit to the impact you can make here. Are you ready to reimagine healthcare?

Here, your career breakthroughs will change the future of health, in all the best ways. And you'll change, too. You'll be inspired, and you'll inspire people across the world to change how they care for themselves and those they love. Amplify your impact. Join us!

At Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and balanced lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it is found. We are Janssen.

Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Janssen provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Immunology, Oncology, Infectious Diseases and Pulmonary Hypertension. Please visit www.Janssen.com for more information.

Position Summary:

The GCO Leadership Development Program consists of 12 months of dynamic rotations in Spring House, PA with in-depth training across the Clinical Trial Assistant, Site Manager, and Local Trial Manager roles, supported by strong line management, formal mentorship, sponsorship, networking, focused leadership development and dynamic real world work experience.

Global Trial Associates (GTAs) will rapidly gain knowledge, develop technical and leadership skills and important insights into how the business operates.

The objective is for the GTA to develop an understanding of pharmaceutical development, GCO standard operation procedures, policies and regulatory requirements, logistical and administrative tasks related to trial management (start-up, execution and closing phases) and patient safety in clinical trials.

The GTA will gain knowledge of and support activities of the Site Manager (SM) and Local Trial Manager (LTM) positions under the direct supervision of LTM and SM mentors, Program Manager, and/or Functional Manager (FM).

Upon successful completion of the program, GTAs will be placed in either the Local Trial Manager or Site Manager role depending on business need and skill set of the GTAs.

Principal Responsibilities:

• Provide administrative and logistical support to Clinical Trial Assistant (CTAs), Site Manager and/or Local Trial Manager in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies, and local regulatory requirements.
• Support the local study team in performing site feasibility and/or country feasibility. Collaborates with the Global Project Team, e.g. Clinical Trial Manager (CTM)/Global Trial Lead (GTL), local management/Country Head and other study team members, as required.
• Maintain information in relevant systems, including electronic filing (electronic Trial Master File: eTMF).
• Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.
• Support Clinical Trial Manager, Site Manager and/or Local Trial manager in collecting/preparing documents required for study start-up/ submission to Ethics Committee/IRB and/or Health Authorities.
• Support Clinical Trial Manager, Site Manager and/or Local Trial manager in collecting, processing, and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.
• May assist team in conducting local investigator meeting or with planning for the investigators participating in an international meeting.
• Maintain and update contact information in relevant systems to ensure appropriate safety updates distribution.
• Comply with all training requirements, company policies & procedures and all applicable laws and regulations. Always act aligned with J&J Credo.
• Ensure inspection readiness at all times.
• May contribute to process improvement
• Support Site Manager, within a reasonable timeframe be able to take on responsibility in executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/ study close-out according to Standard Operating Procedures, Work Instructions (WIs) and policies.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Qualifications

Education and Experience Requirements:

• Must be graduating no more than 12 months prior to the target start date of July 2024, with a Bachelor’s or Master’s degree (e.g., BA, BS, MS), in Health Sciences or related scientific field
• Minimum GPA 3.2. or a U.S. Junior Military Officer who has completed a government assignment
• 1+ plus years of work experience preferred
• IT literacy relevant to Corporate and Clinical Operations
• Must be permanently authorized to work in the U.S. and must not require sponsorship at the time of hire or in the future

Skills:

• Strong verbal and written communication and presentation skills
• Analytical and a real problem solver
• Willingness to learn in a dynamic environment and stay abreast of new technologies
• Strong interpersonal, leadership, and negotiating skills
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
• Ability to perform activities in a timely and accurate manner.
• Expert proficiency with Word, Power Point, Excel.

Travel:

• Ability to work on-site full-time in Spring House, PA
• Ability to travel up to 25% when in Site Manager rotation

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.