Business Process Analyst - FDA/OSE

Chenega Corporation - Silver Spring, MD3.7

Full-time
Chenega Professional & Technical Services (CPTS) is seeking a Business Process Analyst III to support the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE).

Essential Duties and Responsibilities: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position)
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 specifications.
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, compliance and regulations.
Manage communication with all stakeholders (business partners, IT team, service providers) in the project to ensure they 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.

Non-Essential Duties:
Other duties as assigned.

Supervisory Responsibilities:
None.

Minimum Qualifications: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)
Bachelor’s/Master’s degree in business, engineering, MIS, Computer Science, Life Science or related discipline and at least 4 years of experience in the pharmaceutical industry or public health field.
Informatics experience preferred.

Knowledge, Skills and Abilities:
Demonstrable knowledge of one or more functional areas of Pharmacovigilance, Regulatory, Clinical Data Management, Statistical Programming or Clinical Operations.
Demonstrable knowledge of the relevant ICH, EU, and FDA guidelines and regulations for clinical trials and post-marketing environments.
Experience with implementation of pharmacovigilance and risk management solutions such as Pharmacovigilance Systems includes Post/Pre-Market Drug Safety Surveillance, Regulatory Information Systems, Clinical Data Management, Statistical Analytics, REMS, Data Mining Scores, Natural Language Processing, Machine Learning techniques is desirable.
Demonstrate critical thinking skills, sound judgment, attention to detail, and strong organizational and communication skills.
Experience with business process mapping and designing role based flow charts.
Experience in Microsoft suite of tools including Visio and SharePoint.
Experience with business process improvement methodologies.
Strong interpersonal skills with a proven ability to maintain collaborative working relationships with internal business partners, IT team and technology service providers.
Knowledge of Project Management and the role of Project Managers.
Ability to deliver high quality documentation paying attention to detail.
Ability to quickly grasp complex technical concepts and make them easily understandable.
Strong working knowledge of Microsoft Office.
Creates adapts and follows project schedules and deadlines.
Demonstrated ability to work in an agile environment.
Able to manage varying degrees of ambiguity.

Diversity:
Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.

Ethics:
Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
The employee will normally work in a temperature-controlled office environment, with frequent exposure to electronic office equipment.
During visits to areas of operations, may be exposed to extreme cold or hot weather conditions. Is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and loud noise.

Chenega Corporation and family of companies is an EOE.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Sexual Orientation/Gender Identity
Native preference under PL 93-638.
We participate in the E-Verify Employment Verification Program.
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Recruiter Mary Jacenich