Chenega Corporation Project Coordinator (Regulatory) - FDA/OSE in Silver Spring, Maryland
CHENEGA PROFESSIONAL & TECHNICAL SERVICES, LLC
Company Job Title:
Project Coordinator II-OSE-CPTS
Chenega Job Title:
Project Coordinator III
Silver Spring, MD
Exempt, Full Time, Regular
Chenega Professional & Technical Services (CPTS) is seeking a Project Coordinator II to support the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). TheProject Coordinator IIwill be responsible for ensuring quality output of the document development processes for SOPs, MAPPs, and other business process documentation.
Essential Duties and Responsibilities:(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position)
Perform key project management duties to support one or more Project Management Staff teams with respect to coordinating internal and external stakeholder meetings, preparation of meeting materials, data entry in Regulatory workflow tracking tools, drafting acknowledgement letters, regulatory archival of emails to sponsors as assigned by OSE Project Management staff.
Work closely with subject matter experts (SMEs) and senior leaders in OSE Project Management to gather requirements for data entry, letter generation, archival of documents in Regulatory work flow and review tracking tools.
Assist Project Management staff with work tracking and triaging of consults.
Assist leadership in Project management with querying and report generation for the review work and assignments from the work tracking tools.
Gather and document ad-hoc assignments for data calls from other offices as assigned by OSE Project Management Staff.
Provide administrative support to cleanup and maintain the central document repository system for business process documentation.
Perform quality reviews to ensure each 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 each written document for review by SMEs and senior leaders within OSE’s specified timeframes.
- Other duties as assigned.
Minimum Qualifications:(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)
Bachelor’s degree in a health-related field and at least 4 years of experience in the public health field. MPH preferred.
Federal experience preferred; Pharmaceuticals industry experience is a plus.
Pharmacovigilance knowledge is desired.
Knowledge, Skills and Abilities:
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.
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.
- Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
- Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
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.
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.
Organization: Chenega Professional & Technical Services
Title: Project Coordinator (Regulatory) - FDA/OSE
Location: Maryland-Silver Spring
Requisition ID: 1800003460