Consumer Safety Officers: FDA Openings
Center for Devices and Radiological Health, Silver Spring, MD is in the process of hiring several Consumer Safety Officers. If you are interested in working with the FDA please go to USAJOBS and search under the keyword "FDA."
There are currently several openings throughout the FDA.
Bioinformatics Scientist
SRA International is assisting an NIH Institute to collect, sequence, and characterize diseased tissues by supporting data management. We are responsible for data collection, transformation, dissemination, and quality control of this biological data. We also establish and implement standard operating procedures for the transmission, processing, and storage of data by leveraging existing NIH resources for the analysis and storage of information.
- Collaborate and coordinate with the biologists handling tissue specimens, genome sequencing, and genome characterization to establish and execute standard operating procedures for data transmission to and from the data management team.
- Work with these researchers to ensure SOPs are followed and to assist with their implementation.
- Work with researchers to derive and maintain standard vocabularies, data elements, and data models.
- In collaboration with the Technical Lead, design and implement a data management pipeline to process data and prepare it for rapid, public distribution in consistent formats to meet compatibility guidelines. This responsibility includes working with the researchers to derive appropriate bioinformatics data formats.
Required Skills:
Experience: 3-5 years of experience
Degree: PhD
- Experience with high throughput characterization technologies (i.e. gene expression, DNA copy number variation, chromosome rearrangements, DNA methylation, and RNA interference) and the management of data resulting
- from these platforms.
- Experience with working in a cross-functional, fast paced team environment.
- Familiarity with existing data standards from NIH.
- Experience with Unified Modeling Language (UML) and class diagrams.
- Familiarity with MAGE-TAB and MAGE-ML data formats.
Desired Skills:
- Experience in defining and assisting in the development of bioinformatics systems.
- Experience with relational databases.
- Experience with scripting languages (e.g., Perl), XML, and concepts of object oriented development (e.g., Java)
- Experience with software development and testing.
- Experience with XML, scripting languages (e.g., Perl) and concepts of object oriented development (e.g., Java)
- Experience with software development and testing.
Job Information
Position Type: Industrial and Commerical
Reference (Job ID number): 27878BR
Start Date: ASAP
Duration: Full Time
Status: open
Clinical Research Associate (In House)
BPSI is a small business providing biomedical research support to the government and the pharmaceutical industry. We are seeking an energetic CRA who can work as part of a small team in support of both clinical research trials and bid and proposal efforts. Candidate will be responsible for site monitoring, writing case narratives for a data review committee, as well as proposal writing in response to appropriate opportunities. Excellent opportunity and career path for a CRA with 3-5 years of experience.
Position activities and responsibilities include:
- Work with Principal of BPSI on current engagements with top Pharma companies
- On Site Monitoring of a phase III clinical trial (20% travel overall)
- Case narrative development for Data Review Committee
- Take leadership role during any bid and proposal efforts - from draft to submission
- Coordinate BPSI and team member(s) roles and inputs to proposal
- Ensure submissions are timely, accurate and of highest quality
- Perform research for business development opportunities in an inside support role
- Participate in meetings with prospective clients and partners
Required skills, education, experience:
- BS/MS degree in nursing or applied science preferred
- 3-5 years experience as a CRA
- Experience working with government agencies such as HHS and military medical centers a strong plus.
- Excellent verbal, written and presentation skills, as well as the ability to manage multiple pursuits simultaneously.
- Intelligent, flexible, self-starter, motivated, effective, take-charge personality.
- Capable of juggling multiple projects and meeting deadlines and quotas in a fast-paced environment.
- Must have excellent computer, writing, editing and formatting skills.
- Graphic Design a plus.
Successful candidate must report to Severna Park, MD location. We are not able to consider consulting or virtual office arrangements.
Compensation based on experience with excellent benefits package including health, dental, 401K and life insurance.
BPSI is an EOE.
Submit resumes WITH SALARY HISTORY to hr@bpsicorp.com
Laboratory Assistants
Alper Biotech, a Rockville based biotechnology company specializing in the development and commercialization of monoclonal antibodies, is looking for 2 experienced part-time lab assistants experienced in molecular techniques and biohistochemistry.
Immediate available required.
For more information please email Dr. Özge Alper