Standards Regulatory Intelligence Expert - Belgium
provides significant expertise to the IDAR department (and GCDO if applicable) in data submission
requirements and strategy and leads and/or participates in several simple to highly complex cross-
functional initiatives. Together with the Head Standards Regulatory Intelligence, this position will be
responsible for making decisions that have a direct impact on the data submission success of the
overall IDAR department and Janssen.
that need to be aware of any data and data submission requirements and guidance’s (and Janssen
position related to these). This position partners with several internal and external stakeholder
functions to ensure that critical data and data submission requirements are understood fully.
Authorities and Industry organizations and performs impact assessments and/or coordinates internal
reviews based on new or changed requirements to decide on IDAR strategy and priority projects in
collaboration with key stakeholders.
Analysis Submission Experts to provide significant leadership into the development of departmental
policies, guidance’s, training related to submissions and submission standards.
groups and will be focusing on external visibility and information sharing of data standards
requirements and evolutions in Janssen RDO.
medium to high complexity. Participates in several external industry working groups. Able to translate
regulatory and industry requirements and guidance’s into a Janssen interpretation for use.
environment with strong communication, collaboration, facilitation and problem-solving skills.
Supports IDAR submission strategy, planning and implementation activities to ensure IDAR adheres to
Regulatory Authority and Industry standards for submissions:
and submission by active participation in Industry working groups.
2. This position is also responsible for bringing together internal RDO participants to facilitate
external visibility and information sharing in a structured way and ensuring information is
streamlined within Janssen R&D. Facilitate internal review of new and/or updated guidance’s
3. This position is responsible for coordinating the internal review and interpretation of newly
released or updated Regulatory Authority and Industry guidance documentation related to
data and data submissions by bringing together key functions involved. Makes sure that
impact assessments are done for new or updated guidance’s, white papers, requirements etc.
related to data standards and submission regarding current Janssen R&D documentation,
processes and tools that are discussed with stakeholders. Translate new or updated
guidance’s etc. into Janssen R&D business rules and conventions and provide information
sessions and training to make sure stakeholders are up to date with most current
4. This position works closely together with the Data Delivery/Analysis Submission Expert, other
teams within the Clinical Development Standards organization as well as other departments
on the implementation of the new/updated standards and submission guidance’s.
5. This position holds responsibility for ensuring the IDAR department is well informed and clear
on the requirements necessary to adhere to Regulatory guidance’ and acceptable standards
6. Provides guidance to Clinical Development Standards organization, IDAR staff related to data
submission requirements and ensures training to IDAR staff, other departments and CRO’s.
This position has no permanent direct reports but may lead project teams, mentor junior staff and
supervise consultants supporting regulatory intelligence deliverables.
This position reports to the Head of Standards Regulatory Intelligence and effectively interacts with
the other Clinical Development Standards teams, DDA members, MW, Regulatory, TA liaisons, Clinical
Teams, EBIS, biostatisticians, CRO’s etc. This expert also highly focusses on collaboration with Industry
working groups related to data standards/submissions, Regulatory Authorities and several Regulatory
Affairs groups within Janssen (e.g. US, EU, Japan, China, etc..).
Bachelor degree and 8+ years of relevant experience OR Master degree and 5+ years of relevant
experience OR PhD with post doc experience and 4+ years of experience OR equivalent through
experience alone. University/College degree in a scientific discipline is preferred.
submission deliverables, requirements, processes and related topics such as eCTD. Knowledge of
general clinical trial process and more in detail data management and programming practices
(including tools and processes) as well as a comprehensive understanding CDISC standards (e.g.
SDTM, ADAM, define.xml) is required.
negotiation and leading through influence are required. Experience with working in cross functional
teams is required.
Janssen Pharmaceutica N.V. (7555)
Clinical Data Management