Job Description

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Global Trial Leader (Manager) - Medical Affairs Operations. This position can be located remotely within the Continental United States.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy 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 might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

The Global Leader (GTL) - Medical Affairs Operations (MAO) will report to the Global Program Leader (GPL) and will be accountable for end-to-end operational management of data generation activities according to timeline and budget for assigned projects. This includes start-up, execution, close-out, analysis and reporting with high quality standards per company procedures and regulatory requirements. Serve as the single point of end-to-end accountability for assigned programs leading the teams on a global, regional level and/or local level, while partnering with the GPL, Global Operations Head (GOH), Global Trial Manager (GTM) and Clinical Trial Assistant (CTA) to ensure overall program delivery.

Principal Responsibilities:

* Single point of accountability for end-to-end operational management of the assigned projects.
* Accountable for delivery of assigned programs within agreed budget. Ensure accurate project budget management, reconciliation and forecasting for both Out of Pocket (OOP) costs and Full Time Equivalent (FTE) costs. Overall oversight and contract management, including review and approval of external service provider (ESP) contracts, and change orders.
* Track project progress against planned timelines. Ensures timely and accurate documentation and communication of project progress.
* Maintain project compliance within all applicable Health Authority (HA) regulations, guidelines, Standard Operating Procedures (SOPs) and processes. Ensure quality oversight and inspection readiness of assigned projects. Participate in preparation for, and conduct of, HA inspections and audits.
* Ensure correct and timely reporting of safety and product complaints, as appropriate.
* Identify, proactively manages and escalates issues in a timely manner.
Manage risks and creation of proposal for Action Plan(s) with the project team to implement solutions on a project level.

Qualifications
* A minimum of a Bachelors or equivalent University degree is required, preferably in a Life Science discipline.
* A minimum of 8 years of clinical research experience within the Pharmaceutical industry or Contract Research Organization (CRO) is required.
* Experience in the following Therapeutic Areas preferred: Oncology, Immunology, Cardiovascular, Neuroscience, Infectious Diseases and Vaccines.
* Experience with Clinical Trial Phases I through IV is preferred.
* Working knowledge of regulatory guidelines (International Conference on Harmonization (ICH), Good Clinical Practices (GCP)), company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol specific procedures required.
* Experience with interventional and non-interventional studies preferred.
* Project management skills required.
* People leadership skills preferred.
* Strong financial/budget management skills required.
* Strong computer skills in appropriate software applications and related clinical systems required.
* Must have excellent communication skills.
* Must be an agent of change management.
* The ability to collaborate with all levels and influence decision-making in a virtual and highly matrixed environment is required.
* Willingness to travel with occasional overnight stay(s) based on business needs is required.

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.

Primary Location
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Other Locations
United States
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D;
Requisition ID
2105888952W