Project Manager - Pharmaceutical REMS (Risk Evaluation and Mitigation Strategy):
Orion Innovation

1551029878
Orion Innovation
Princeton New Jersey
Pharmaceutical
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Description

Project Manager - Pharmaceutical REMS (Risk Evaluation and Mitigation Strategy)


Project/Domain Overview

Outline of key responsibilities & deliverables:

The project manager will report to the program lead and will work closely with the vendor PM. Typical project manager tasks would include:

· Support projects and initiatives within the REMS business area

· Learn the project objectives and detailed business requirements to provide continuity of vision and understanding across the team throughout the full lifecycle of the project

· Identify, track and actively manage dependencies, working closely with the Portfolio Manager on any cross-team dependencies

· Proactively anticipate, track and mitigate project-related issues and risks

· Proactively manage finances of the project. Track Actuals to Budget. Provide financial metrics - EAC, ETC.

· Understanding of Agile methodology. Understanding of the tools used to manage the agile projects using these tools.

· Manage Contract approval process from getting the contracts, reviewing, approval till the approval and PO is issued.

· Build and update project charters, which should be considered living documents to be updated as plans, budgets, resources and scope change

· Develop Communication Plan/Operating Cadence to ensure appropriate team engagement

· Conduct planning meetings, workshops with project core and extended team members and develop a project schedule to ensure complete delivery schedule; obtain team buy-in and baseline

· Develop a RACI to establish clear roles and responsibilities

· Communicate baseline schedule and important milestones to each stakeholder, set expectations as to their responsibilities and provide reminders as appropriate to ensure project progress per the baseline schedule

· Follow SDLC processes, gates and procedures and PMO best practices for managing projects (which include the change control process needed to capture data around reasons for change)

· Unblock or escalate issues to the Portfolio Manager in a timely manner; then drive and own mitigation

· Proactively review the health of projects from various perspectives (feedback from key team members, past trends, project retrospectives, etc.) and take corrective measures to ensure successful project delivery

· Communicate with the Portfolio Manager and associated Business Partner frequently regarding changes in project status and ensure that data is kept up to date in the EPM system. Provide transparency into project status, accomplishments, issues and risks, and next steps on a regular cadence set by the Portfolio Manager, with event-driven updates as needed

· Make Project Retrospectives a routine, periodic activity during the project lifecycle; capture and communicate to the team and to the larger community using the Lessons Learned process and database

· Work closely with the Portfolio Manager and solution architects to give the IT build and run teams in GPT and GDS early visibility into upcoming demand related to the projects managed

· Ensure the quality and on time delivery of SDLC artifacts and documents related to projects managed, as well as timely execution of SDLC gate check processes

· Coordinate cost estimation and track project-related accruals, budgets, forecasts and forecast revisions. Responsible for Purchase Orders, as well as updating and reconciling actual financials, and tracking expenses incurred;

· Work closely with the Portfolio Manager, Program Managers and PMO Operations to identify and promote best practices and continuous improvement in PMO processes, systems, tools and reports

· Work closely with Sourcing and Vendor Management on contracts

· Actively use PMO compliance reports to ensure project data is accurate and timely, updated weekly (at a minimum) and on an event-driven basis as changes occur

· Lead project team meetings and ensure that team meeting minutes are taken, accurate and available for team review. Action items from these meetings are the responsibility of the Project Manger to assign to the appropriate owners, and to ensure actions are closed in a timely manner


Experience and Skills:

Required Skills and Education

· Minimum bachelor's degree

· Project manager with at 10-12+ years of experience in implementing solutions in a pharma / biotech environment

· Demonstrated SDLC understanding and experience

· Experience with Agile methodology. Understanding of the tools used to manage the agile projects using these tools.

· Understanding of pharmaceutical quality management and validation

· Strong collaboration and excellent communication skills

· Ability to work in complex matrix organization

· Strong risk and issues management capabilities

· Ability to manage multiple conflicting priorities

· Large Project Management Office experience with multiple project interaction

· Desire and ability to drive projects to completion

· Ability to interface effectively with all levels in the organization

· MS Office proficiency including; PowerPoint, Excel, SharePoint and MS Project


Preferred Skills/Certifications

· Knowledge of Risk Management preferred

· Project Management Professional or equivalent preferred



Duration open-ended.


Please submit resume to :

ID: #REQ145411


"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, citizenship status, disability status, marital status, genetic information, protected veteran status, or any other characteristic protected by law."