8 jobs found in rockville

IQVIA MedTech is now hiring for a Regulatory & Start -Up Specialist for a home-based opportunity.**Basic Functions:**Prepares, performs and follows-up on regulatory submissions to Institutional Review Boards (IRB) and other applicable bodies according to the relevant legislation and guidelines for clinical trials with medical devices (e.g. ICH-GCP, ISO 14155, MDR, FDA 21 CFR) under supervision of the Regulatory & Start-up Manager.**Responsibilities:**+ Search and verifies IRB submission requirements.+ Drafts IRB submission documents (e.g. application form, ICF, ).+ Prepares IRB and other applicable submission packages.+ Follows-up on development and collection of required regulatory documentation.+ Ensures timely filing of submission documents.+ Ensures regulatory tracking systems/databases remain updated.+ Follows-up on submission status and ensures resolution of all questions and comments under supervision of the Regulatory & Start-up Manager.+ Acts as an intermediary...

* Duties Help Duties Summary This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Criminal Investigations (OCI), Headquarters - Immediate Office; as the Senior Advisor to the OCI Assistant Commissioner for Criminal Investigations. Telework available at management's discretion. Learn more about this agency Responsibilities * Perform difficult and highly complex assignments of great significance to the organization and of a national scope. * Resolve a broad range of issues in relation to the application of FDA?s enabling legislation and pertinent or general legislation affecting operation of the Federal government. * Provide authoritative advice and guidance on technical policy matters concerned with regulation, enforcement and administration centered around the programs and activities critical to OCI operations. * Serve as a primary advisor and key member of OCI's leadership...

GDIT is looking for an analyst and tester to support a client's intranet initiative. The developer will deliver innovative solutions for improving the effectiveness, reach, and content of the intranet site to improve the effectiveness of the client's workforce. Our team will sustain, expand and improve the Drupal-based site with static and dynamic content, including integration with other internal and external sources. The candidate will be responsible for working across the software life-cycle, with an emphasis on analysis and testing. As such, this role requires a combination of understanding and capturing the requirements of the system, and to validate the implementation of those requirements through testing. The candidate will apply behavior-driven development (BDD) approaches to align these analysis and testing activities. The best candidate has a strong understanding of industry trends and using agile methodologies for analysis and testing and applying user experience/user...

Summary: The role of the Senior Network Engineer is to manage a dynamic AWS cloud-based network consisting of network resources that support multi-tiered HA/Clustered AWS Transit Routing, Firewalls, Load balancers and Monitoring capabilities using various cloud services within AWS. Other services like Checkpoint, Cisco ASA, Cisco routers, and operating systems (Windows and Linux) are a possibility in an on-prem contract. This role involves coordinating with department team to plan, design, and schedule the release of all software and hardware, updates and upgrades. This role is a member of large technical team responsible for the design, development and implementation (DDI) of Medicaid Management Information System (MMIS) for multiple states. This high-volume system operates out of multiple data centres and cloud environments like AWS and Oracle. Must reliably be available to its clients. This is a contract position for 6 months. Working remotely within the United States is...

Senior Accountant Immediate Role-Flexible and Remote! About the Company and Opportunity: • Our client is a small pharmaceutical company in the field of cancer research. This is an exciting company with an entrepreneurial spirit creating an atmosphere of excitement with the work they are doing! • Due to growth, they are hiring a Senior Accountant in their Rockville, MD headquarters with a pay rate of $40-$45 an hour. The yearly salary is $80,000. This is a mostly remote role with the option to work in the office 3 days a week in a private office or to just stop by to pick up the mail in office and return home to work in your home office. • The position plays a key role for the companys finance department, by leading all US • accounting activities and monthly close processes. The position is a direct report to the Controller. • Qualifications include 2-3 years accounting experience. Industry not important. Very strong bookkeeping skills (Senior, AP, Payroll). Someone easy to work...

DescriptionThe purpose of this position is to provide technical support to the Director, Accounts Payable and Payroll, the Director, Financial Reporting, and the Director, Budget and Pension by preparing payroll analyses, reports, and allocations; ensuring timely and accurate reconciliations; and providing support for on-going payroll and accounts payable functions.Responsibilities1.Process bi-weekly payroll including review timesheets and attendance records and correct inaccuracies, review and balance payroll before and after they are processed, and ensuring payroll deposits are made timely2.Analyze and reconcile all payroll related general ledger accounts and prepare journal entries to record payroll related transactions3.Prepare and analyze payroll reports, including the monthly personnel budget performance report; identify and explain major variances between budget and actual.4.Analyze and reconcile quarterly and annual tax reports5.Develop reports and process improvements...

**Description:**The specific duties assigned to the Clinical Programmer Contractor are as follows:1. Provides proficient SAS programming skill including: validation of analysis datasets, reports, tables, listings, statistical analyses to satisfactorily fulfill requirements. While some programming is maintenance programming (modifying existing programs), the majority is writing new programs.2. Converts moderately complex scientific and other technical problem formulations to format processed by computer.3. Resolves statistical formulations, and encodes resultant equations for processing by applying knowledge of branch of science, or advanced mathematics, such as differential equations or numerical analysis, and understanding of capabilities and limitations of computer software.4. Works with team members to review output and confers with other scientific and technical personnel to resolve problems of intent, inaccuracy, or feasibility of computer processing. Determines the necessity...

Staff Accountant GC Biller Mostly Remote position! About the Company and Opportunity: • Our client is a small government contractor that needs a temporary replacement to start ASAP! This assignment is expected to last 2-3 months maybe longer and could become a permanent role for the right candidate! • Due to growth, they are hiring a Staff Accountant GC Biller where the position will be remote except for one day a week in their Rockville, MD office. This position pays $28 - $32 hourly during the contract. • Candidates must have Deltek Costpoint and experience with government contract billing (TM, FP) and contract set-up and analysis. • Some of the employee reviews, include things like: • Management is very driven. Great benefits and recognition with the bonuses • Like a big family with good work-life balance and flexibility. HR is knowledgeable and relates to employees in a very personal way. Overview of the Staff Accountant GC Biller role: • Will have responsibility for revenue...