Integrated Data Analytics and Reporting TA Lead (1 of 2)
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Integrated Data Analytics and Reporting TA Lead be based in either Spring House PA, Horsham PA, Raritan NJ or Titusville NJ, Beerse, Belgium or High Wycombe, UK
At 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. We pursue the most promising science, wherever it might be found.
We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com to learn more.
The IDAR (Integrated Data Analytics and Reporting: data management, risk management - central monitoring, programming and medical writing) TA Lead is accountable for the overall strategy associated with IDAR deliverables within his/her assigned therapeutic area, in close collaboration with the Portfolio Delivery Operation Heads. This strategy includes traditional IDAR deliverable approaches, use/creation of standards and templates, utilization of tools and platforms, functional sourcing decisions, risk-management approaches and optimal dataflow to support real-time data availability. The IDAR TA Lead will lead the internal IDAR cross-functional team ensuring alignment within IDAR and realizing efficiencies across IDAR functions. The IDAR TA lead is the first point of contact in IDAR for new compounds and programs.
The IDAR TA lead will represent IDAR in a leadership capacity for their assigned area.
- Interacts within and outside IDAR, in close collaboration with the Portfolio Delivery Operation Heads, to ensure execution of the IDAR strategy, proper prioritization and alignment across IDAR, for their assigned therapeutic area.
- Responsible for the cross-functional IDAR strategy and deliverables.
- To optimize collaboration, the position will establish and build strong relationships within IDAR and with GCDO, QS and other relevant stakeholders such as, but not limited to, the Project Management Organization, Bioresearch Quality & Compliance, and Regulatory Affairs.
- Reviews resource planning, prioritization, and allocation to ensure optimal support.
- Accountable for ensuring IDAR expertise is available as needed, and is responsible to deal with conflicts in priority setting and related resourcing for assigned area.
- Maintains a complete overview for the portfolio and IDAR's critical path activities for assigned area.
- This individual will lead the cross-functional IDAR team and ensures alignment of IDAR leads.
- Maintains overview of sourcing strategies applied to area.
- Maintains overview of vendors utilized within area and budgets associated with deliverables.
- Supports IDAR leads during vendor selection process, audits, budget management and issue escalation as needed.
- Serves as IDAR point of contact for the area as appropriate, or in the absence of an IDAR lead.
- Ensures IDAR operational issues/challenges are proactively identified and addressed through operational risk mitigation, including proposals for alternative solutions.
- Escalates and cascades issues within IDAR to ensure transparency and appropriate communication across IDAR. Communicate trends in issues/challenges.
- Coordinates L&A activities for IDAR to ensure appropriate resources are assigned and input provided.
- Participates in establishing the strategy and direction of IDAR within GCDO and contributes to strengthening IDAR capabilities.
- Engages with Functional Managers within IDAR to ensure appropriate lead assignments to new programs.
- Articulates requirements of programs to facilitate assignment of employees by functional managers.
- Provides timely feedback on performance of IDAR leads to functional managers.
- Engages the Capabilities team within IDAR when new data types, processes and models are identified.
- Aligns IDAR processes and priorities to maximize IDAR effectiveness; implements innovative approaches to enhance IDAR productivity and effectiveness.
- Shares learnings to speed innovation.
- Oversees RDO initiatives related to standards, process improvements, regulatory compliance and other key department, cross-functional activities as assigned.
- This position will report to the Head of IDAR and will collaborate with others to ensure the execution of GCDO and IDAR mission and vision.
DECISION-MAKING AND PROBLEM SOLVING:
- The IDAR TA lead is charged with making decisions that impact IDAR's delivery strategy within their assigned therapeutic area.
- These decisions would need to be aligned with goals and objectives, timelines and budgets of the area as well as IDAR's goals and objectives. The IDAR TA Lead will cascade priorities and resolve conflicting priorities in conjunction with the GCDO Project Delivery Organization.
- The IDAR TA lead is responsible for implementing processes within their scope and reinforcing compliance with standards and IDAR processes.
- BS/BA degree is required
- An advanced degree (e.g., Masters, MBA, MD, PhD) is preferred.
- 10- years of experience in a leadership function in clinical operations is required.
- Expert knowledge required in at least one of the following areas:
- (data management/programming/risk management - central monitoring/medical writing).
- 5+ years of project management and/or functional management is required,
- as well as TA experience and strong portfolio knowledge.
- A good understanding of data management/ risk management - central monitoring/programming/medical writing practices is preferred.
- Good knowledge of regulatory guidance documents such as ICH requirements.
- Demonstrated written and/or communication skills is required.
- Demonstrated leadership and decision-making skills is required
- Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational & business challenges is required
- Demonstrated innovative thinking to allow for optimal execution of clinical development strategies is required.
- Trusted, inclusive leader with demonstrated experience in managing and monitoring cross
- Ability to travel, domestic and international, up to 20%
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
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