ERG conducts assessments of programs and practices related to FDA review of applications for new medical products. We examine review, communication, and staffing activities to identify what works well and what can be improved. We then provide evidence-based findings and recommendations to decision makers and other parties interested in enabling timely access to safe and effective medicines. ERG’s Junior Analysts build the data foundation for these assessments; they also help analyze, interpret, and report data, and provide other support to meet project objectives.
Duties and Responsibilities
Methodologies, for example:
- Help develop metrics, including definitions, data sources, and calculations
- Help develop, test, and QC data collection protocols and instruments
Data collection, for example:
- Collect, organize, and QC raw data from FDA databases
- Coordinate interviews with diverse groups of people to obtain qualitative data; create and standardize notes for analysis
- Gather survey data from FDA, industry, and other interested parties
- Observe meetings between sponsors and FDA review staff to assess meeting content
- Enter, update, and QC information in databases
- Follow policies and procedures that keep data and information secure as it is collected, analyzed, stored, or discarded
Data analysis, for example:
- Help identify and track key evaluation metrics
- Analyze data and produce visuals to identify trends, patterns, anomalies, and other insights
- Produce and interpret assessment results
- Synthesize findings and suggestions
Reports and presentations, for example:
- Draft reports and presentations to summarize findings and help inform decisions
- Review and maintain project documentation, reports, and presentations
- Provide operational support for meetings with clients and other project stakeholders
Qualifications
Qualifications include:
- Bachelor’s degree (major in a biomedical or health science preferred)
- Skills
- Excellent attention to detail
- Organizational and time management skills
- Strong interpersonal, written, and verbal communication skills
- Good critical thinking and problem-solving skills
- Computer literacy and proficiency with MS Office software
- Abilities
- Able to work effectively with diverse groups of people (ERG project teams, client teams, interested parties)
- Able to recognize need for help and ask for help when needed
- Able to obtain security clearance
Working Conditions
At ERG, we provide a friendly, supportive work environment that helps us all to learn, grow, and succeed. For this position, most ERG team members work remotely, though we offer space in our offices if desired. We work both collaboratively and independently. Dress is casual or business casual.
We work with sensitive data. All project team members obtain a Public Trust Level 5 security clearance, take FDA training on secure data management, and maintain strict confidentiality for sensitive information.
Reports To
ERG contract manager for program evaluation projects.
Successful candidates must be committed to working with a diverse and inclusive team.
Eastern Research Group, Inc. is an equal opportunity employer and complies with applicable EEO and affirmative action regulations. EOE/Minorities/Females/Vet/Disability
Please be aware, the only authentic corporate domain for Eastern Research Group, Inc. (ERG) is https://www.erg.com. ERG may, on occasion, screen applicants via telephone or video interviews via Skype, Teams, GoToMeeting, or another type of video platform. However, any candidate extended a job offer will be asked to meet in person with an ERG employee before being asked to provide confidential personal information associated with new employment.
For applicants that require an accommodation: As a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access ERG’s online application process as a result of your disability. Please contact Human Resources via e-mail at
[email protected] or telephone 781-674-7293 to request an accommodation.
There’s a reason ERGers are so dedicated. We work in a friendly, flexible, inclusive environment with clients who are committed to making the world a better place. We promote and recognize principles of fairness, equity, and social justice in the work we do, partnerships we foster, and culture we value both within and outside of our organization.
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