Johnson & Johnson is recruiting for a EMEA RMC Data Management to be located in Morocco.
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The EMEA Regulatory Management Center (ERMC) is a regional Regulatory Affairs organization responsible for the majority of the operational regulatory maintenance activities, acting on behalf of EMEA Local Operating Companies (LOCs) and led by Senior Regulatory Staff.
ERMC handles tactical Life Cycle Management (LCM) processes like CMC and Labeling variations in the region. ERMC is embedded in the EMEA RA regional organization and works in close collaboration with the respective LOCs, regional and global teams.
ERMC is a virtual team reporting directly to the ERMC management and is located in the EMEA countries working mostly in the LOCs.
This position is envisaged to support a large, diverse and complex geographic EMEA region.
The responsibility of the ERMC Data Management is to cooperate with ERMC Lifecycle Management, ERMC Labeling Management, ERMC Planning, ERMC Compliance, other respective GRA stakeholders and LOCs respective RA staff on assigned CMC and Labeling variations, by performing specialized activities in the submission process for all countries within their cluster or even region.
The ERMC Data Management has a direct reporting line to the ERMC Data Management sub-team Lead.
This is a fixed term contract position.
ERMC Data Management role
Data and record management (ensuring all assigned records in global systems and databases are filled-out and regional records are set up correctly and in time), including but not limited to :
InSight : responsible for timely and accurate communication of impact assessment for assigned CMC variations using the applicable templates according to the type of procedure and submission as well as update throughout submission and approval process (as applicable);
responsible for timely and accurate communication of actual submission and approval dates for assigned Labeling variations (as applicable);
responsible for timely provision of information and approved PI for XEVMPD notification (EEA only).
LIFT : responsible for timely impact assessment entry for assigned Labeling variations; timeline adjustments and extensions when applicable;
set-up records for locally triggered changes as applicable.
SPS : responsible for timely impact assessment entry for assigned CMC variations, update throughout submission and approval process and 2nd verification.
GRAIL : responsible for archiving all relevant HA communications related to the assigned submissions.
Using the E2E Dashboard for better overview of actions for assigned Labeling variation records.
Following-up with link between InSight and LIFT in terms of data accuracy for variations in scope of ERMC.
Ensuring Compliance and Audit readiness within own tasks considering all applicable Procedural Documents, including participating in audit-readiness activities.
Contributing to implementation of new Systems and Processes applicable to Data Management activities to ensure efficiency gains and to support Business Continuity.
Participating actively in internal process improvements.
Communicating effectively with other ERMC sub-teams and Stakeholders.
Supporting other team members in Data Management activities.
REQUIRED COMPETENCIES (J&J REGULATORY AFFAIRS COMPETENCY MODEL)
Applied Technical Knowledge (Applying) : Leverages knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to develop compliant Regulatory strategies that are aligned with business objectives.
Executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status.
Exhibits curiosity and passion to continuously learn about new scientific, technological, and Regulatory developments and explains Regulatory impact of risks to business partners.
Business acumen (Applying) : Leverages knowledge of the sector, organization, Regulatory Affairs function, and cross-functional business partners to make informed business decisions and create and execute business strategies.
Assesses the impact of current regulatory requirements on the business to assist in the development of innovative Regulatory strategies and / or innovative ways to execute them.
Executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Manages projects within timeline requirements.
Decision Making & Priority (Applying) : Clearly defines and prioritizes decision criteria and considers benefits and risks of each decision and its immediate and future implications.
Considers all of the available facts when situations are ambiguous in order to make the best possible decision. Manages multiple and changing priorities based on factors such as time constraints, urgency, and business need.
Manages complex or ambiguous situations including integration of large amounts of changing, complex, or ambiguous information.
Leading & Influencing (Learning) : Leverages an understanding of others’ motivations, needs, and concerns to establish trust and credibility and influence others.
Demonstrates conviction, proactivity and persistence when influencing internal and external stakeholders with or without direct authority or formalized structure.
Creates compelling negotiating positions that build support and consensus among key stakeholders. Leverages internal networks to enhance collaboration, information sharing, and form strategic partnerships.
Persuasive Communication (Applying) : Delivers and creates tailored communications and presentations that educate and mobilize critical stakeholders and translates complex information into key facts and rational arguments that are influential, meaningful, and actionable.
Fully engages others by asking incisive and thought-provoking questions, always ensuring mutual understanding. Develops written technical communications that are influential, meaningful, and tailored to the audience and business need, including translating complex or technical information into simplified explanations to promote understanding.
REQUIRED TECHNICAL COMPETENCIES & KNOWLEDGE Regulatory Knowledge
Good understanding of the Pharmaceutical Industry and Regulatory Experience in Drug Development and / or maintenance of Marketed Products.
Intermediate knowledge of Local and Regional Regulations and Guidance in the region related to full drug life cycle.
Awareness of the scientific principles (CMC, clinical and non-clinical) applicable to the specific products.
Knowledge of quality and supply chain and potential impact to regulatory procedures and status of products. Process oriented
Essential submission knowledge : procedures, timelines and requirements
E2E Labeling and CMC process knowledge
Process oriented and understanding of connections and interactions. RA System proficiency
RA system knowledge (document management, planning and tracking, databases .)
Strong in data gathering and interpretation; drive to find information
Multitasking, accurate and conscientious
Knowledge of regulatory systems (e.g. InSight, LIFT, GRAIL). Compliance oriented
Ability to link legal and company internal requirements with regulatory process aspects and the applicable task management
Understanding of compliance requirements and ability to influence outcomes. Working in an international environment with other parties
Ability to quickly acquire country specific knowledge and shift between local situations (learning agility)
Intercultural sensitivity to enable smooth collaboration with colleagues across EMEA. Language skills
Ability to communicate fluently in English (oral and written) and good general understanding (including business and technical RA English)
General feeling for languages able to comprehend essentials without detailed understanding in different languages. Drive execution
Project management : own time management, work in virtual teams, task prioritization, drive execution
Communication skills and cultural sensitivity in working with stakeholders across countries and continents
Team player able to effectively collaborate with colleagues in a virtual environment and able to do efficient handovers
Required leadership competencies
Connect : Communicate and cooperate efficiently / constructively with applicable stakeholders, both within ERMC (other ERMC sub-teams) and outside ERMC (other GRA stakeholders like C&BS team and GL team), acting as a team player and aiming for common solutions.
Shape : Shape the role of the Data Management team within ERMC; find gaps, provide solutions and implement these solutions to ensure growth.
Deliver : Deliver a competent and efficient Data Management team, to ensure high quality and timely documentation of submission / approval of lifecycle changes and new MAA
Decision-making and problem-solving
Operates in a competitive, complex, and rapidly changing environment.
Independence on decision-making regarding own specialist areas and regional strategies with supervisor approval.
Identify and act on process optimization opportunities.
Defines operational priorities within own specialist area.
Makes informed decisions by soliciting input from others where needed.
Raises gaps or open questions to management where appropriate.
Decisions and problem-solving require interpretation of applicable country-specific and company procedures, policies, standards, and regulations in drug regulation but will not be explicitly circumscribed by these.
WORKING RELATIONSHIPS / INTERFACES With LOC :
Local Regulatory Affairs staff, as needed, for country specific tracking in systems, align on procedures specific for data management activities, updates needed to license and marketing status in InSight. Within ERMC :
ERMC Planning as needed
ERMC Lifecycle Management on assigned NP, EU MRP, EU DCP submissions (throughout pre-submission to post-approval)
ERMC EUCP Coordinators on assigned EUCP submissions (throughout presubmission to post-approval)
ERMC Translation Management to obtain approved PI for XEVMPD purposes
ERMC Artwork Management on updating corresponding LIFT records and finding synergies
ERMC Data Management colleagues to align on processes and improve internal materials / processes, participate in common projects / SME roles, share best practices, back-up activities.
ERMC Compliance colleagues to align on compliance specific requirements and assure the appropriate evaluation and documentation Within Global Regulatory Affairs :
Global and Regional teams (e.g. EMEA Compliance & Business Support, GRA Q&C, Global Labeling CoE) to manage procedures and projects as applicable in specific areas.
KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILLS REQUIREMENTS EMEA RMC Data Management
A minimum of a University degree or equivalent by experience
At least 2 years of Regulatory Affairs experience
Proficiency in written and spoken English (including Business English)
Excellent verbal and written communication skills
Experience of working in a virtual team and / or global organization is an asset.
Experience in working with limited supervision and able to make independent decisions
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 Regulatory tracking systems is an asset (eg. InSight, LIFT)
Working conditions / travel requirements
The position is located in the EMEA region. No relocation is required. Must be able to work flexible hours to accommodate early morning / evening meetings / teleconferences with different time zones.
Occasional international travel (1-2 per year) may be required.