Show:
Dynamic Funding
Planisware
Team Kick Off
Own it
PSPT's
100
Used to secure funding for a project?
What is a Dev Co Memo?
100
Biosimilar mAb ADC LCLV
What are the old Templates used in Planisware
100
Key Deliverables: Manage supply and release CTM to sites Update Clementine with requirements and supply related information Contributes to maintaining Genealogy/Pedigree table
What are some of the Key Deliverables of the Supply Chain Rep
100
Own the Business
What does the "O" in Own It Stand for?
100
Btx / DSRD Collaboration tool
What new tool was made available for use by the PSPT's in 2013?
200
RADEX
What is governing body for Dynamic Funding?
200
Used by the RU's and BU's for long range planning and forcasting
What are Cross-functional Plans
200
Establishes and administers project SharePoint collaboration space PSPT champion and subject matter expert (SME) for the project plan, financials, and FTE forecasting Actively brings forward opportunities for project acceleration and cost containment opportunities along with associated execution risks for the PSPT team’s consideration Coordinates with the Finance organization to review project related forecasts and projections. Manages project accruals as required Is the champion for conducting project plan scenario analysis for schedule and resources (financials and FTE’s)
What is role of the Project Manager?
200
Trust in one another
What does the "T" in Own It stand for
200
Primarily responsible for Pedigree Table
What is one of Quality Ops deliverables?
300
$500,000
What is current flexibility/overage amount allowed prior to securing additional funding?
300
Cross functional Plans for early projects prior to CS
What are new Can's
300
Coordinate and review all filing submissions Incorporate filing review suggestions Coordinate agency responses to questions. Ensure all responses are completed in an appropriate time which supports the project strategy Forecast all planned filing activities and supporting regulatory requirements to the PSPT Draft B IND F2F Review
What are some key deliverables of the GCMC rep?
300
2012
When was the "Own it" program launched?
300
Dosage Material Identification Sheets
What is DMID
400
Project forecasts and project actuals
What are two inputs needed to effectively manage dynamic funding?
400
MSP plans focused internally to the Teams & Planisware Light focused for external partners
What planning tool are used for internal line planning and what tool is used for external planning
400
File Names should have primary references such as Product PF#/Batch# and or Document Type if possible Save files in GDMS with appropriate search attributes Strategic partner GMP documentation should be collected and added to GDMS at completion of service All summary development reports and presentations should be added to GDMS inclusive of Genealogy/Pedigree table
What are good documentation management practices of the PSPT?
400
>220,000
How many "Own it" messages have been sent to colleagues?
400
Primary responsible for Develop outsourcing plans: timelines, cost projections, resource requirements, and deliverables with strategic partners
What is Outsourcing
500
Enables DevCo to rely on proof of science and feasibility to manage budgets Prevents prematurely terminating projects before the scientific hypothesis is validated Balances near term trigger points against a line of sight for upcoming asset decisions, to ensure robust decision making and optimal funding allocation
What are the benefits of Dynamic Funding
500
Metadata Table
What "table" links Planisware fields and BI to enable Portfolio reporting?
500
Provide forum for Pharm Sci Project Teams (PSPTs) to raise issues for senior leader guidance Review and endorsement of Pharm Sci development strategy and alignment on risk registry and mitigation strategy to address technical, regulatory, or timeline based issues Technical review of molecular assessment and risks for projects that are in discovery space (pre-CAN)
What is role of the PPMT
500
Great Manager Awards Individual Performance Awards Innovation Awards Safety & Sustainability Star Awards W.E. Upjohn Awards
What are the "Own It" Corporate Awards?
500
Ensures Pharm Sci deliverables to RU Understand RU priorities Partner with RU to maximize portfolio value Ensure portfolio needs are addressed Look ahead to future capability, capacity, technology needs SPOAs bring RU upcoming resource requirements to S&T line portfolio Leads through PICM meeting for Cross-RU discussion
What is the SPOA responsible for?