Evidence Generation Program Manager at Johnson & Johnson

Requisition ID: 2105982258W
Category: R&D
Contract: Permanent

Overall Purpose of this Job

• To provide Evidence Generation program management leadership for specified Therapeutic Areas within GPH Medical & Scientific Affairs and ensuring all activities are executed in time, in a compliant way and within budget.
• In addition to his Therapeutic Area oversight, the Evidence Generation Program Manager will also have project management responsibilities for specific Evidence Generation projects.

Key Responsibilities
The responsibilities & the impact YOU will have:

Therapeutic Area Evidence Generation Program Oversight:

• 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. 

Qualifications
We’d love to hear from YOU, if you have:

Required:

• Bachelor's Degree, Master's Degree or higher in a Science-related subject, Project Management.
• Minimum of 5 years of industry experience in clinical trial operations, pharmacovigilance, regulatory affairs or quality management.
• Project management experience
• Good 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.

This is What Awaits You at J&J

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