Pharmaceutical Research & Development, L.L.C., a member of the Johnson
& Johnson Family of Companies, is recruiting for a Senior
Analyst, Global Medical Safety Operations (GMSO) Safety Readiness. This position can be based in
the following locations: Horsham, PA; Raritan NJ; High Wycombe UK.
the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters
most is helping people live full and healthy lives. We focus on treating,
curing and preventing some of the most devastating and complex diseases of our
time. And we pursue the most promising science, wherever it might be found.
Research & Development, LLC discovers and develops innovative medical
solutions to address important unmet medical needs in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
are Janssen. Our mission drives us. Our patients inspire us. We collaborate
with the world for the health of everyone in it.
Analyst, Global Medical Safety Operations (GMSO) Safety Readiness is
responsible for supporting the Global Medical Safety (GMS) inspection readiness
and CAPA commitment program, including tracking of audit/inspection/CAPA
activities and the generation of associated metrics. The Senior Analyst will
have working process knowledge and will support GMSO or other assigned
deliverables as required. The Senior Analyst will partner with GMS team
members, stakeholders, and Subject Matter Experts (SMEs) to continuously
improve GMS state of inspection readiness.
Analyst will also work closely with functional area representatives to support
the business, act as GMS liaison during audit/inspection, and may serve as
delegate for their manager.
GMS Inspection Readiness Support
- Liaise with Compliance
Standards and Analytics (CSA) and maintain the GMS SMEs list regarding audit/inspection
readiness; act as GMS liaison during inspection/audit
- Support the establishment of audit readiness and proactive
practices for GMS including operational process monitoring (“spot checks”)
to ensure functional area compliance and documentation inspection
- Monitor and track GMS audit and inspection participation
- Develop GMS Inspection Readiness Metrics/Dashboards for
presentation to GMSO Operational Performance leadership.
- Facilitate communications to GMSO and applicable GMS (e.g. MSSI,
MSA, etc.) leadership on ongoing/upcoming CAPA records and
SME audit and inspection training in collaboration with CSA.
Support the development, tracking,
trending and execution of all CAPA commitments assigned for GMS.
- Provide Business
Support of CAPA commitments assigned to GMS to ensure CAPAs authored by
functions are robust and inspection ready
- Ensure appropriate
GMS stakeholder participation within CAPA development through to CAPA
operational/business technical guidance, additional SME recommendations,
consultation on query requests to CAPA Owners.
generation of CAPA metric presentation/dashboard, CAPA escalation and tracking
for presentation to the GMS Leadership/Governance Committee.
- Provide individual
CAPA summaries for assigned CAPAs.
- Ensure tracking of
assigned CAPA Owner Event/Deviation/CAPA presentation to ensure timeliness of
review/approval by of GMS functional area leader, stakeholders, Leadership
team(s) etc. to meet PV CAPA Center of Excellence (COE) timelines.
- Author summaries for individual CAPAs
in department and/or cross-functional initiatives as appropriate
with team members and stakeholders to ensure a consistent approach to
deliverables and across department.
- Other duties
GMSO Archiving activities in compliance with internal records management
standards to support vita record retrieval.
- A Bachelor’s degree is required; an Advanced
Degree is preferred.
- A minimum of 3 years’ relevant experience is
- Experience in Pharmacovigilance, Clinical
Profession or allied field with CAPA or inspection readiness oversight and
operational experience in a multi-functional organization is required
- Demonstrated ability of coordinating
multi-functional activities in a highly regulated environment resulting in
concrete business results is required
- Experience in Quality Management, Project
Management and/or Process Excellence concepts and practices is preferred
- Strong knowledge and experience with
pharmacovigilance (safety) processing/reporting and regulatory compliance
issues is required
United States-Pennsylvania-HorshamOther Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function
Drug & Product Safety Science