30 Jul 2020

ERMC RA Lifecycle Management at Johnson & Johnson

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Job Description

Johnson & Johnson Middle East. is recruiting for a ERMC RA Lifecycle Management, RA Professional to be located in Cairo, Egypt.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science — bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.

Sector Overview

The Regulatory Management Center (RMC) is a regional organization responsible for most of the operational regulatory maintenance activities, acting on behalf of LOCs and led by senior regulatory staff. The RMC handles tactical Lifecycle Management (LCM) processes for Labeling changes in the region. The RMC is embedded in the AP, EMEA and LA regional organizations and works in close collaboration with the respective LOCs and regional/ global departments.

The RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports).

Summary Of The Job
The responsibility of the ERMC RA Lifecycle Management (LCM) is to coordinate a broad range of product lifecycle changes for multiple countries in the EMEA region, from planning of the submission up to implementation of the change in the applicable databases and, if applicable, artwork.
The current job opening is for a LCM RA Professional for the Non-EEA region for MEWA Labeling submissions.

Duties & Responsibilities
Coordinate lifecycle maintenance procedures (Labeling changes) in-scope of ERMC, plus any other regulatory procedure as assigned to ERMC in agreement with the ERMC Head.
Coordinate procedures from planning through to global dispatch, submission, HA approval and implementation in the applicable databases and artwork, where applicable.
Liaise with LOC to set submission strategy and timelines for NP activities.
Liaise with EMEA Liaison, CMC-RA and/or LOC for preparation of submission-ready documents or dossier(s).
Ensure timely submission of a good-quality (response) dossier.
Manage validation issues or HA questions and prepare response documents/dossiers in alignment with EMEA Liaison, CMC-RA and/or LOC.
Process HA approvals appropriately, to allow implementation steps and other post-approval activities to be initiated in a timely manner.
Finalize/archive applicable documents/tools as soon as post-approval activities are completed, changes are implemented in artwork (if applicable) and databases are closed.
Involve ERMC colleagues for specific process steps like completion of databases, preparation of local PI and/or preparation of artwork. The LCM RA Professional is responsible to provide correct triggers at the correct time; however, the LCM RA Professional is not responsible for correct/ timely completion of the tasks by the other ERMC sub-teams.
Perform all country specific activities as described in RIACS (local regulations and country specific requirements as provided to us by the LOCs) and in alignment with the LOCs.
Perform all lifecycle management activities by following ERMC processes, templates and other applicable guidance documents implemented for the LCM team specifically or the ERMC team in general.
Act as backup LCM for assigned procedures/countries/cluster(s) in urgent cases and/or as assigned by ERMC LCM sub-team Lead or ERMC LCM Lead, to ensure quality/ continuity of all lifecycle management activities.
Act as mentor for new LCM colleagues, if so assigned by the EMEA LCM sub-team Lead or EMEA LCM Lead.
Lead projects for LCM and/or act as a subject matter expert, if so assigned by the EMEA LCM sub-team Lead or EMEA LCM Lead.
Ensure regulatory compliance of the Lifecycle Management activities and participate in audit-readiness activities where required.
Main performance measures (Performance Goals)
Janssen is looking for a talented, experienced regulatory affairs professional to join the EMEA RMC (ERMC) team. The role is to focus primarily on the coordination of procedures within the ERMC team; ensuring compliant, high quality and timely submissions to the Health Authorities for lifecycle management activities for Janssen products. The successful candidate will be dedicated to a cluster of countries and will work closely together with local and regional project teams.
The ideal candidate will bring in this role a high level of awareness of the applicable regulatory environment. The candidate will further require a pro-active attitude, problem-solving capabilities and excellent communication skills.

Qualifications

A minimum of a University degree or equivalent by experience
Minimum of 3 years in regulatory affairs experience for Labeling variations
In depth knowledge of local and regional regulations/legislation
Experience in regulatory Lifecycle Management, in co-operation with HAs
Arabic and English

Leadership Behaviors Required
LIVE OUR CREDO: Demonstrate and inspire the behaviors that reinforce Our Credo.
CONNECT: Develop deep insights into the needs of our patients, customers, markets and communities.
SHAPE: Drive innovation; anticipate and shape industry and market changes to advance health care globally.
LEAD: Create an environment where leadership and talent development is top priority.
DELIVER: Deliver results by inspiring and mobilizing people and teams.

Technical/Functional Skills Required

The following experience is seen as an advantage:
Working in a virtual environment
Experience in a global organization
Experience in a local affiliate organization
Experience in working with limited supervision and able to make independent decisions
Excellent verbal and written communication skills
Proficiency in written and oral English
Cultural sensitivity and ability to work and thrive in a multi-cultural environment
Proactive team player, able to take charge and follow-through
Achievement-oriented with a high degree of flexibility and ability to adapt to a changing (regulatory) environment
Proficient use of technology including RA tracking systems is preferred

 


          Method of Application

Submit your CV and Application on Company Website : Click Here

Closing Date : 30th August, 2020.




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