Chenega Corporation Research Analyst II (Regulatory) - FDA/OSE in Silver Spring, Maryland

CHENEGA PROFESSIONAL & TECHNICAL SERVICES, LLC

Company Job Title:

Research Analyst II-OSE-CPTS

Chenega Job Title:

Analyst II, Program

Clearance:

NACI

Location:

Silver Spring, MD

Reports To:

Program Manager

FLSA Status:

Exempt, Full Time, Regular

Prepared Date:

9-28-2018

Approved Date:

9-28-2018

Summary:

Chenega Professional & Technical Services (CPTS) is seeking a Research Analyst II to support the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). The Research Analyst II will provide research and operations support of day-to-day research activities conducted to support regulatory reviews and to support activities related to opioid epidemic for the Office of Medication Error Prevention and Risk Management (OMEPRM).

Essential Duties and Responsibilities:(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position)

  • Development of process improvement tools.

  • Conduct additional research required to understand the changes in the healthcare industry and how it affects the regulatory work performed by OMEPRM.

  • Conduct research on partnerships with public or private sector organizations that OMEPRM should explore to help us make a broader impact.

  • Assess staff training needs and research appropriate venues/courses to address the identified training needs.

  • Help OMEPRM modernize the current training programs.

  • Conduct research on packaging interventions and childhood poisonings), policy, and legislative efforts around packaging, storage, and disposal options to enhance opioid safety.

  • Conduct research to see how REMS authorities could be used for mandatory training, documentation of safe use conditions required packaging, and required disposal system etc.

  • Track progress and support the strategic plan goals.

  • Provide day-to-day assistance to research activities conducted to support regulatory reviews.

  • Assist with managing biosimilar suffix review process.

  • Assist with tracking and management of research portfolio.

  • Epidemiology data collection, processing and summary report generation.

  • Search, identify, and evaluate sources of drug abuse data.

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 degree in a health science or public health-related field and at least 4 years of experience in the pharmaceutical industry or public health field. MPH in Quantitative or Social Sciences preferred.

Knowledge, Skills and Abilities:

  • Experience in writing and editing public documents in the pharmaceutical industry or public health field.

  • Demonstrate critical thinking skills, sound judgment, attention to detail, and strong organizational and communication skills.

  • Ability to quickly grasp complex technical concepts and make them easily understandable.

  • Ability to deliver high quality documentation paying attention to detail.

  • Proficient in the use of excel functions to organize and analyze data.

  • Ability to create charts, graphs, and presentations.

  • Ability to collect, interpret and synthesize information and distill large amounts of information.

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.

M#

Organization: Chenega Professional & Technical Services

Title: Research Analyst II (Regulatory) - FDA/OSE

Location: Maryland-Silver Spring

Requisition ID: 1800003459