Project Manager (Business Process)

Description

Description

Provide program/project management and business process support to a team within FDA's Office of Surveillance and Epidemiology.

• Serve as the primary author and editor to capture business requirements for developing written documents pertaining to the support of multiple OSE work streams and efforts for improved informatics as assigned by OSE Regulatory Science staff.
• Perform quality reviews to ensure business requirements specification document is accurate, consistent with FDA laws, regulations and policies, includes all important concepts, meets the writing style requirements of the agency, follows the appropriate template and are written at an appropriate comprehension level for the intended audience.
• Produce working and final drafts of written business requirements specification document for review by SMEs and senior leaders within OSE’s specified timeframes.
• Review existing use cases inventory and prepare for meeting with business staff to complete the documentations.
• Facilitate and gather requirements, use case development, perform business and gap analysis.
• Map respective business processes (As Is - To Be) and identify instances where existing processes may be streamlined or improved prior to and/or in alignment with a technology solution.
• Manage system lifecycles by using the Software Development Life Cycle (SDLC) methodology including scope, gathering of business requirements, user requirements, functional specification.
• Work as a cross-functional team member, critically evaluate and manage user requests to ensure accurate prioritization and optimal resolutions.
• Conduct ongoing assessments to confirm that implemented solutions meet business requirements and comply with regulations.
• Manage communication with all stakeholders (business partners, IT team, service providers) in the project to ensure they are kept aware of the status of all work.
• Partner with key staff in the functional areas (e.g. Pharmacovigilance, Risk Management, Premarket Safety Reports, Signal Enhancements, Data Mining, Data Analytics, Data Visualization and internal process improvements) when appropriate to ensure requirements conform to
applicable regulations.
• Manage project tasks to ensure user requirements and artifacts are documented and delivered per plan.
• Lead communication with internal staff and technology service providers to bridge the requirement gaps.
• Proficiency in SharePoint site development and management highly desired.

Requirements

Minimum Bachelor's degree and 12 years of experience. Ideal candidate would have an advanced degree.

* Project/Program Management skills
* Client Facing/ Stakeholder Management
* Team Leadership
* Excellent Problem Solving skills
* Excellent Interpersonal and Communication skills
* JIRA/WIKI
* Proficiency in Excel 
* SQL reports knowledge is a plus, but not required
* Access Database knowledge

Skills and Qualities:

• Strong writing, verbal, and organizational skills
• Strong analytical ability
• Ability to work independently as well as within a team environment
• Excellent oral and written communication skills. 

DISCLAIMER: The above statements are intended to describe the general nature and level of work performed. They are not intended to be an exhaustive list of all responsibilities, duties, skills, efforts, requirements, or working conditions. Management reserves the right to revise the job or to require that other or different tasks be performed as assigned in accordance with business demands and/or contractual requirements.