Beerse

IDMP Data Technology Lead – PG26

JnJ Consumer

Locations : EU or USA (Skillman, NJ or Fort Washington, PA)

Key accountabilities:

• Accountable for identifying technology requirements to coordinate with IT teams in the implementation of IT tools related to IDMP in the context of the wider IDMP programme and strategy for J&J Consumer sector.
• Identify opportunities and proposals to increase connectivity and interface between various data repositories and systems to support IDMP data gathering and transformation to support overall data management plan.
• Accountable for developing technical work instructions for data management in conjunction with IT leads and cross functional team.
• Relationship management between key stakeholders and programme workstream groups.
• Project execution of technical systems and new processes to support IDMP programme readiness, working with J&J IT.

Roles & Responsibilities

• Design and develop IDMP software applications and organise data services in conjunction with IT leads and cross functional teams. Define success criteria and key needs.
• Working with J&J IT, define, plan and coordinate 3rd party IDMP software, integration and implementation.
• Define and coordinate additional software tool assessment(s) as needed.
• Be the technical expert / advisor for the programme in aspects of data transformation needed for IDMP preparation and execution.
• Work with RA, SC and other system leads / experts to define data interface needed to connect specific data systems to the IDMP IT platform.
• Determine workflow process for data linkage and workflows for offshore data analyst team.
• Liaise with technical leads from adjacent programmes (RIM, MDM data management, IDMP RA team) to determine data format, coding and linkages needed to connect and transform IDMP related data sources.
• Participate in the cross functional workstreams as required.
• Coordinate technical systems plans with IT lead(s) and System leads.
• Responsibility to ensure workstream tasks are aligned with other cross functional workstreams and overall IDMP programme.
• Take part in business process re-engineering to implement IDMP preparation and submission within the organisation.
• Report progress in line with functional targets to the IDMP Programme Leader and cross functional team leads.
• Work within broad project guidelines but liaise closely with more senior colleagues to discuss issues and resolve conflicts.
• Produce quality work that meets the expectations of programme lead and key stakeholders.
• Prepare and / or deliver presentations on the subject with the support of senior colleagues.

Qualifications

Technology Experience- not required but good to have in one or more of these areas:

• Oracle databases
• SAP
• Regulatory Information Management platforms (e.g. Liquent/Aris Global/Cunesoft/Veeva)
• Machine Learning/AI application to data management.

Skills and Competencies desired:

• 4-6 years’ experience in a pharmaceutical industry Regulatory and / or Supply Chain Data management / MDM / Regulatory system operational role.
• IT programming skills and familiarity with EU regulatory IT data process and coding (eg XEVMPD) – not required but good to have
• Degree level or higher education in software or related engineering or STEM subject with significant systems involvement
• Knowledge of EU regulatory environment and processes for medicinal products.
• Document and records management, content management familiarity / experience desirable.
• Advanced skills in Microsoft excel and / or Access.
• Previous exposure to Regulatory Information management systems and / or ERP systems.
• Project management knowledge
• Strong analytical abilities
• An excellent team player with sound leadership skills.
• Business acumen
• Proactive and Results Oriented
• Excellent interpersonal and intercultural communication skills

Primary Location
United Kingdom-England-High Wycombe-
Other Locations
Europe/Middle East/Africa-Switzerland-Zug-Zug, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw, North America-United States-Pennsylvania-Fort Washington, North America-United States-New Jersey-Skillman, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
J&J Consumer Services EMAE., Ltd (8675)
Job Function
Clinical Data Management
Requisition ID
0001