Evidence Generation Program Manager by J&J Family of Companies

• Maintain oversight of all Evidence Generation related activities within Medical & Scientific Affairs program planning based on ongoing activities & new activities approved during Business Planning exercises and ensure activities are delivered within timelines and budget.
• Ensure risk mitigation, contingency plans are developed for key activities, checked against available budget and implemented as appropriate
• Responsible for maintenance & update of programs on the relevant Evidence Generation dashboards for the TA(s) of responsibility.
• Collaborate with Therapeutic Area leads to manage budget planning, tracking and reporting in accordance with finance reporting cycles.Data Collection Project Management (Company sponsored studies & Investigator initiated studies, Publications:
• Ensure all projects are properly developed, set-up and executed by the Program Management team within timelines & budget.
• For Medical Affairs projects executed by GCDO, ensure that GCDO-Medical Affairs Operations is aware of GPH Evidence Generation Program planning.
• Ensure GPH Publication plans are properly developed and coordinated by the teams within timelines & budget.Compliance:
• Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOP's (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors;
• Ensure HCC and legal requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors.

• Bachelor's degree, master's degree or higher in a science-related subject, project management.
• Minimum 5 years of industry experience in clinical trial operations, pharmacovigilance, regulatory affairs or quality management.
• Project management experienceGood understanding of the varying clinical research practices (Phase III to IV clinical trials, Post Marketing Data collection activities, Investigator Initiated Activities and related activities
• Excellent knowledge of study design & execution and related regulations (GCP, European Directives,).
• Good working knowledge of publication management, benefit/ risk management, real world data, and access programs.
• Medical writing skills
• Leadership, people management and development skills
• Highly innovative with the ability to drive multiple projects within a complex and changing environment, and effectively manage and resolve issues within program management teams
• Excellent interpersonal and interdependent partnering skills.
• Strong and demonstrable communication and influencing skills that can impact at a Global and regional level
• Good knowledge of GPH product range & priority therapeutic areas
• Ability to work effectively in a matrix environment, with multi-cultural, virtual teams.For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

• Many opportunities to work on challenging projects and assignments.
• Possibilities for further personal as well as professional development.
• Many employees benefits.

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