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Standards Regulatory Intelligence Expert - Belgium  

Company managed [?] Still accepting applications

Posted on : 10 September 2017

Project Description


Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world and employs more than 4,000 professionals in Belgium. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
The Standards Regulatory Intelligence Expert within the Standards Regulatory Intelligence Team
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.
The Standards Regulatory Intelligence Expert serves as the single point of contact for all stakeholders
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.
This position primarily focuses on data and data submission requirements from Regulatory
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.
The Standards Regulatory Intelligence Expert works closely together with the Data Delivery and Data
Analysis Submission Experts to provide significant leadership into the development of departmental
policies, guidance’s, training related to submissions and submission standards.
This position will also play a very significant role in representing Janssen at external Industry working
groups and will be focusing on external visibility and information sharing of data standards
requirements and evolutions in Janssen RDO.
The person is expected to lead cross functional projects and impact assessments of
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.
Must have demonstrated leadership and project management experience in a cross-functional team
environment with strong communication, collaboration, facilitation and problem-solving skills.
rincipal Responsibilities

Supports IDAR submission strategy, planning and implementation activities to ensure IDAR adheres to
Regulatory Authority and Industry standards for submissions:

1. Keep abreast with Industry and Regulatory Authority requirements related to data standards
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
and feedback.
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
requirements.
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
for Authorities.
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 will report to the Head Standards Regulatory Intelligence.
4. Responsibility for Others (if applicable):

This position has no permanent direct reports but may lead project teams, mentor junior staff and
supervise consultants supporting regulatory intelligence deliverables.
5. Principal Relationships

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..).

Qualifications
Education and Experience Requirements:

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.
In depth knowledge of regulatory guidance related to clinical research is expected and critical for data
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.
Project management experience, dealing with customers, leading teams to successful outcomes,
negotiation and leading through influence are required. Experience with working in cross functional
teams is required.

What’s in it for you…?

“Caring for the world, one person at a time…”

As an employee we consider you as our most valuable asset. We take your career seriously.

As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth.

Our benefits make sure we care for you and your family now and in the future.


Primary Location
Belgium-Antwerp-Beerse
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Clinical Data Management
Requisition ID
1700193846W