Project Manager Sample Job Description

Project managers are the people in charge of a specific project or projects within a company. As the project manager, your job is to plan, budget, oversee and document all aspects of the specific project you are working on

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Summary

Utilizing a cross-functional project team approach, develops and ensures the execution of a high-quality, high-velocity, cost-effective pharmaceutical development plans aimed at meeting assigned project objectives (generally approval of development projects by regulatory authorities). Drives optimization of project timeline and resource utilization. Secures flexibility through anticipating needs for contingency planning while, balancing timeline, cost, risk and value. Manages and ensures resolution of project team issues through influence. Drives team member accountability for project success. Manages software tools and reports to communicate project status to the senior level of the organization

Job Results, Essential Functions & Measures of Success

Approved Regulatory Submissions & Pharmaceutical Development Projects
Essential Functions Leads the development and implementation of a comprehensive, integrated plan for each assigned project. Works with cross functional project teams including Regulatory Affairs & Technical Development groups to ensure high quality submissions. Maintains systems to organize overall project information. Manages the PC-based project management database and other tracking systems that are used to manage/coordinate the activities of the project.	*Measures of Success* NDA submissions on time (100%) Approvable letters received within desired timeframes (100%) Effectiveness of management of project information (100%) Effectiveness of PC-based tool for reporting and monitoring achievement of project milestones (High) Demonstration of understanding of Pharmaceutical Product Development including clinical, technical and regulatory requirements (Medium)

Approved Regulatory Submissions & Pharmaceutical Development Projects

Essential Functions

Leads the development and implementation of a comprehensive, integrated plan for each assigned project.
Works with cross functional project teams including Regulatory Affairs & Technical Development groups to ensure high quality submissions.
Maintains systems to organize overall project information.
Manages the PC-based project management database and other tracking systems that are used to manage/coordinate the activities of the project.

Measures of Success

NDA submissions on time (100%)
Approvable letters received within desired timeframes (100%)
Effectiveness of management of project information (100%)
Effectiveness of PC-based tool for reporting and monitoring achievement of project milestones (High)
Demonstration of understanding of Pharmaceutical Product Development including clinical, technical and regulatory requirements (Medium)

Effective Project Team(s)
Essential Functions Facilitates the development and communication of project objectives, and ensures the approved objectives are achieved by the project team(s). Chairs project team meetings; organizes and coordinates agendas for project team meetings and strategic reviews, including follow-up minutes and action items. Ensures that team members understand and are committed to their specific objectives and to the ultimate goal of the project(s). Closely monitors the status and results of all activities carried out under the project plan(s). Keeps plans up-to-date and ensures discrepancies are being resolved. Identifies project roadblocks early in the process, and brings any areas of conflict with respect to resource allocation (budgets, manpower) to resolution. Insures resolution of cross-functional issues within the project team. When no resolution can be reached, ensures that issues are promoted Acts as a liaison with all functional areas to keep them informed on the progress of the project and to ensure proper integration of activities as well as facilitation of decisions required to move the project forward. Keeps Senior Management informed of project status and completion of key milestones.	*Measures of Success* Existence of key milestones (y-n)) Team effectiveness rating (1-5) Successful, timely completion of project milestones by each team member assigned (100%) Alternate plans available when needed (y-n) Alternate plans take appropriate level of risk/reward (y-n) U.S. Executive Team Members say: They have the necessary information to understand project status and chosen development pathways. They understand key issues and risk/rewards of chosen course. That the Project Team is effectively managing the objectives of the project. Project Team Members say: They have the necessary information in time to be useful and have the authority to carry out their aspect of the project. They understand the priority of the project within their deliverables. Project Manager, by example, encourages team members to do what they have to with no feeling of “that’s not my job.” Project Manager invites innovative ideas from all levels to improve deliverables to the customer.

Effective Project Team(s)

Essential Functions

Facilitates the development and communication of project objectives, and ensures the approved objectives are achieved by the project team(s).
Chairs project team meetings; organizes and coordinates agendas for project team meetings and strategic reviews, including follow-up minutes and action items.
Ensures that team members understand and are committed to their specific objectives and to the ultimate goal of the project(s).
Closely monitors the status and results of all activities carried out under the project plan(s). Keeps plans up-to-date and ensures discrepancies are being resolved.
Identifies project roadblocks early in the process, and brings any areas of conflict with respect to resource allocation (budgets, manpower) to resolution. Insures resolution of cross-functional issues within the project team. When no resolution can be reached, ensures that issues are promoted
Acts as a liaison with all functional areas to keep them informed on the progress of the project and to ensure proper integration of activities as well as facilitation of decisions required to move the project forward.
Keeps Senior Management informed of project status and completion of key milestones.

Measures of Success

Existence of key milestones (y-n))
Team effectiveness rating (1-5)
Successful, timely completion of project milestones by each team member assigned (100%)
Alternate plans available when needed (y-n)
Alternate plans take appropriate level of risk/reward (y-n)

U.S. Executive Team Members say:

They have the necessary information to understand project status and chosen development pathways.
They understand key issues and risk/rewards of chosen course.
That the Project Team is effectively managing the objectives of the project.

Project Team Members say:

They have the necessary information in time to be useful and have the authority to carry out their aspect of the project.
They understand the priority of the project within their deliverables.
Project Manager, by example, encourages team members to do what they have to with no feeling of “that’s not my job.”
Project Manager invites innovative ideas from all levels to improve deliverables to the customer.

Critical Success Factors

Negotiation (Balancing Budget Against Trade-Offs)

Identifies and proposes solutions that benefit all parties involved in a situation; seeks out and builds relationships with others who can provide information, intelligence, career support, potential business, and other forms of help; accurately anticipates the implications of events or decisions for various stakeholders in the organization and plans strategy accordingly; can negotiate skillfully in touchy situations with both internal and external groups

Drives Execution

Coaches, mentors, and motivates project team members and influences them to take positive action and accountability for their assigned work. Demonstrates effective skill in planning, supervising, monitoring, and accomplishing projects. Knows how to organize people, activities, and processes to get things done efficiently and effectively. Exhibits passion for driving process and projects, and for achieving success through continuous innovation and execution to plan.

Project Management

Knows how to organize people and activities; can see opportunities for synergy and integration where others can’t; coordinates the diverse components of projects by quality project planning, execution and change control to achieve the required balance of time, cost and quality; manages projects according to a standard process by using a systems development lifecycle; effectively directs and integrates all aspects of a project or program, ensuring that work progresses toward achieving goals and objectives.

Problem Solving

Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn’t stop at the first answers.

Business Case Development

Uses financial analysis to evaluate and create strategic choices and options; knowledgeable about how the business and organization work; knowledgeable in current and possible future policies, practices, trends, and information affecting the business and organization; understands the competition; is aware of how tactics work in the marketplace; devises an approach that best positions an idea, plan or activity; leverages supportive factors, breaks through barriers, and addresses the unique needs and preferences of key decision makers.

Position Qualifications

Minimum Education & Experience:
BSc/BA degree in a scientific discipline, advanced degree preferred. Other backgrounds with demonstrable delivery of pharmaceutical development projects will be considered. Seven (7) years in the pharmaceutical industry, at least three (3) as a project manager managing complex pharmaceutical projects. Experience in bringing project through NDA approval process. At least 4 years contributing to technical achievement of pharmaceutical projects as an individual contributor (preferably in Product or Analytical Development or Regulatory Affairs).

Required Skills:

Demonstrated skill in delivering cross-functional pharmaceutical projects to successful completion.
Working knowledge of pharmaceutical approval process.
Superior communication skills and ability to develop teamwork among staff.
Must be diplomatic and possess good human interaction skills.
Supplier problem resolution skills.
Knowledge of the requirements for FDA filings (NDAs, ANDAs, Supplements). International filings a plus.
Knowledge of the product, process and analytical development requirements for Pharmaceutical Products.
Some knowledge of Compliance requirements (GLPs, GCPs, GMPs, etc.).