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U.S. Pharmacopeia
Project Manager I/II/III - Small Molecules
Location: Rockville,
Maryland-Montgomery County
20852
Posted on:
9/16/2009 10:51:54 AM
Postion type:
Full time
Job Code:
BW10503
Required Education:
Bachelor's Degree
Salary:
DESCRIPTION
Function of the Position:
This is a project management position in the Documentary Standards Division (DSD) reporting to the vice president of the Small Molecules Department (SMD). The incumbent is responsible for project management and coordination of activities in support of development and revision of monographs for small molecular weight pharmaceuticals (drug substances and the associated dosage forms) in the USP-NF and for the Pending and Non-US initiatives
The Department works closely with the Departments of Publications (PUB) and Volunteer & Organizational Affairs (VOA), and General Chapters (GC) within DSD and the Departments of Standards Acquisition (STA), Reference Standards Evaluation (RSE), Reference Standards Operations (RSO), and Applied Compendial Research (ACR) in Reference Material Division (RMD). This department works closely with the global pharmaceutical industry, regulatory authorities, the Council of Experts and other stakeholders to develop meaningful public standards.
Roles and Responsibilities:
Provide Project Management Support for Departmental and Interdepartmental Collaborations
Supports various routine and non-routine compendial projects, activities and initiatives. Responsible for working with SMD VP, Scientific Liaisons and staff from other departments. General activities include:
o Support and document preparation related to accelerated revisions (e.g, web notices, forms, etc)
o Ballot reconciliation and Commentary preparation, as needed
o Initiation and tracking of ACR laboratory requests (e.g., monograph modernization, investigations, etc) with laboratory protocol development and report review, as needed
o Tracking and coordination of compendial initiatives (e.g., Pending Monographs, prospective harmonization)
o Represent SMD in cross-functional meetings, as needed
Provide Project Management Support to USP’s Council of Experts and Related Groups
Supports Expert Committee, Advisory Panel, and Collaborative Group meetings and related activities (workshops, subcommittees, etc.) for Small Molecules as needed. General activities include:
o Notetaking at meetings
o Action item tracking and management
o Production meeting participation, as needed
o Presentation assistance and development
Provide Project Management Support to Standards-Setting Team(s)
Provides project management and logistics support for Standards-setting Team(s) assigned to the Small Molecules Department. Responsible for working with the Department VPs and other staff, as assigned, to:
o Coordinate and schedule Team meetings
o Develop and disseminate meeting agendas
o Track progress against metrics
o Track development of new and revised standards
o Coordinate work of the Team, especially cross-divisional communications and handoffs
o Produce meeting minutes for review, and disseminate when final
Tracks and reports frequently on the status of assignments to management
Performs other duties as assigned
Frequent Contacts:
Vice President, Small Molecules
Other department management and staff
Members of the USP Expert Committees and Advisory Panels of the Council of Experts
Reference Material Division staff
Knowledge, Skills, Abilities, Training and Experience:
Knowledge of USP standards-setting processes and compendial terminology
Laboratory experience in analytical chemistry techniques
Knowledge of project planning and management with successful management of multiple projects/activities
Advanced computer competence (MS Office programs, MS Project or similar, internet, email data bases and workflow systems)
Knowledge of the pharmaceutical industry and the associated regulatory framework is helpful
Excellent facilitation, conflict resolution, and team building skills in the management of cross-functional activities
Superior interpersonal skills: professionalism, accountability, helpfulness, delegation, and customer service
Excellent verbal and written communication skills
Excellent critical thinking and problem solving skills
Strong time management skills
Strong organizational skills and attention to detail
Excellent presentation and reporting skills
Supervisory Requirements:
None
Status:
Exempt
REQUIREMENTS:
Minimum Experience:
Project Manager I:
Bachelor’s degree required, advanced degree preferred. A minimum of three years of relevant experience or project management skills.
Project Manager II:
Bachelor’s degree required, advanced degree preferred. A minimum of five years of relevant experience or project management skills.
Project Manager III:
Bachelor’s degree required; preferably in a physical or life science, advanced degree preferred. A minimum of seven years experience of relevant experience or project management skills.
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