REQUIREMENT:
• Conduct statistical programming work of clinical data using SAS Version 9 or above
• H1B Sponsorship available
• Ensure that all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs.
• Participate in the review of ‘Statistical Analysis Plan’ and other documents essential to the conduct of statistical programming work for clinical trials;
• Generate analysis data sets according to CDISC standard and SAP
• Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS. Conduct adhoc analyses.
• Validate programs and associated results produced by other programming colleagues.
• Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, time line and deliverable are met;
• Develop standard SAS macros for efficient analyses of clinical data supervised by senior programmers.
• Function as lead programmer in individual project teams for oversight of timeline, quality, and delivery.
• For Levels II and III, participate in TLF shell preparation and review, and assist statistician for SAP preparation.
REQUIREMENT:
• Support the submission and distribution of reports and relevant tracking Support distribution and tracking of distribution of Follow-Up letters;
• H1B Sponsorship available
• Support inspection preparedness activities policies and practices as per Company SOPs;
• Consistently apply Archiving policies as per Company SOP.
• Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries and collection of safety data
• Reflects the Patient Safety philosophy of being a team player and supports the development of those individuals within the department
• Working knowledge of technology required for Patient Safety
• Establishing Dossier Plans for the assigned Global submission types as needed to support the life cycle of one or more products. The candidate will be responsible for: generating dossier plans that will reflect inputs from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and time lines against established KPIs.
• Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
• Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
• Support development of departmental work practices, process enhancements, and associated training materials.
• Develop/maintain associated process tools and relevant training documentation.
The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas (i.e. spine, trauma, and cranio-maxiofacial areas) and/or medical devices (mostly mechanical implants and instruments such as plates, screws, meshes, cages, etc.) in the DePuy Synthes Strategic Medical Affairs Team for a wide range of audiences. Note: I don’t think it is absolutely critical that the person has experience in these particular devices. It would be nice, but not absolutely necessary, as long as they have experience in mechanical type devices versus electrical / chemical / biological products. Also, many MDs would likely have a good appreciation of the therapeutic areas but if their specialties / experience is more pharmacological, they still don’t seem like the best fit. I also don’t think it is necessary to have an MD.
Key Job Activities:
• Primarily focuses on preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to regulatory authorities (e.g. notified bodies).
• Participates in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
• Performs scientific writing (e.g. abstracts, manuscripts, presentations).
• Organizes and incorporates information for documents, such as references, graphics, tables, and data listings.
• Ensures documents are produced in accordance with European law (i.e. Medical Device Directive (MDD), a.k.a. 93/42/EEC), procedures, internal and external guidelines (e.g. MEDDEV 2.7.1) – this is a key guidance document that I did not see once on the resumes, and electronic templates.
• Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, business objectives, clinical data/evidence
• Independently, critically writes and edits scientifically complex documents for substantial intellectual content.
• Reviews and provides input on clinical data being considered for presentation and/or publication to ensure alignment with scientific strategies and corporate goals.
• Expert knowledge of clinical research, device– (drug side is minor & potentially negligible need in this business unit) development processes, regulatory requirements, good clinical and data management practices.
• Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users.
• Performs MAUDE data base reviews
• Communicates with various departments (e.g. (European) Regulatory, Product Development (typically bioengineers or mechanical engineers), Clinical Research, Quality) to identify the necessary clinical and technical information.
Job Qualifications
Education
• Ph.D plus 1 to 2 years of related medical device experience (e.g. medical writing, regulatory affairs, clinical research, engineering)
• BS/BSN or MS plus 4 to 5 years of relevant medical device industry experience
Knowledge/Requirements
• Excellent English language skills, especially writing and proofreading.
• H1B Sponsorship available
• Clinical, scientific or research background, highly preferred.
• Experience writing CERs, highly preferred.
• Knowledge in narrative or systematic literature reviews (e.g. PRISMA, Cochrane), highly preferred.
• Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines, preferred.
• Expert understanding of scientific or clinical research and methods.
• Understanding of statistical data and good data management practices.
• Strong oral communication, presentation, project management and prioritization skills.
• Excellent interpersonal relationships.
• Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager).
REQUIREMENT
• The Regulatory Compliance IT team is looking for a Senior IT Systems Analyst. In this role, you will work with both IT teams and other internal organizations to gather requirements associated with Regulatory Compliance applications such as Actimize, FircoSoft, Bridger, WorldCheck and internal systems. The Senior IT Systems Analyst reviews and communicates business objectives and translates into technology specific requirements. The positions will also collaborate closely with business and technical resources in support of various testing activities and phases. This position will be responsible for leveraging advanced analytical, research and problem solving skills to define innovative technology solutions in cooperation with developers to meet business objectives.
• The Senior IT Business Systems Analyst will also perform analysis and design activities on complex IT initiatives by eliciting, defining, validating and translating business functional, non-functional and information objectives, then validating them when implemented, as well as preparing status updates on a regular basis to all stakeholders.
• The ideal candidate will possess a deep and broad understanding of Information Technology best practices and processes. Additionally a strong and demonstrated strength in analysis and support of a broad spectrum of BSA/AML and Regulatory systems is required.
• 30% Illicit, analyze, validate and manage technical requirements definition, flows and deliverables for projects. Perform this by working with business partners to understand work effort requirements and then translate into IT actionable tasks.
• 30% Working closely with the IT team to deliver business requirements. Partner closely with technical teams supporting data movement, application development and testing. Diligently support and lead where needed various activities between the teams to ensure the business and technical requirements and objectives are met. Ensure appropriate project documentation is compiled and proper review and approvals from respective teams as gathered and collated.
• 10% Contribute to the the overall system(s) design. Evaluate current processes and procedures to ensure relevance and accuracy. Make recommendations for changes and keep documentation current.
• 10% Perform as the subject matter expert on the various AML systems and processes assigned. Inclusive of this is gathering a deep understanding of the data within the systems and business processes supported by the system(s).
• 10% Build critical working relationships with the business and users communities through gathering a thorough understanding of the business models and processes employed.
• H1B Sponsorship available
• End Client/Customer: EROS:
• 4+ years in QA
• Manual testing – mobile app
• Strong communication and documentation skills
• White box testing
• Experience with Linux Commands.
• Knowledge of Quality Assurance principles, methods and processes
• Solid understanding of mobile technologies and applications
• 2+ years of experience in mobile application testing or equivalent software technologies
• Experience working in an Agile environment
• Significant experience designing and executing QA black box test conditions
• Experience testing and validating functionality, user flows and visual designs
• Ability to learn quickly and work in a fast paced environment with quick turn around
• Highly organized and detail oriented
• Automation
• H1B Sponsorship available
The Test Automation Engineer will work for 6+ months as part of the project team which consists of developers on the IT side and Informaticions on the user side. He/she will review and automate a catalog of ~400 test cases (Regression, UAT…) whenever feasible.
Deliverables:
• Feasibility Analysis.
• Strategy including prioritization to automate existing test cases with SELENIUM.
• SELENIUM scripts to automate manual test cases.
• Coach the development team in writing SELENIUM scripts.
• Provide guidance and rules to determine which test cases can and should be automated and which not.
• Creates reports containing test metrics and status for the management team.
• Assesses quality of existing scripts on a different project.
Requirements:
• CSTE or CSQA certification.
• H1B Sponsorship available
• Minimum of 5 years of professional QA experience.
• Minimum of 2 years of professional experience using SELENIUM.
• Familiarity with formalized test methodology and associated artifacts.
• Knowledge of J2EE development environment.
• Excellent communication and facilitation skills.
Desirable:
• Knowledge of Agile Testing Practice
• Knowledge of relational database design structure concepts.
• Knowledge of SQL statement syntax.
Summary:
The Senior Web Designer is responsible for the design, development and maintenance of web applications and components. The primary focus is to support and maintain the envato.com public web site. A deep understanding of the site architecture (both functional and technical) and how it supports the business vision and processes will be vital. Will identify, design and implement web site enhancements by working closely with a team of internal marketing/sales stakeholders, and with external digital ad agency and application vendors. Adheres to KBHIT processes/methodologies including request management, application development and release management.
Duties and Responsibilities:
Works closely with a team of internal marketing and sales stakeholders as well as with and external digital ad agency and application vendors to define a compelling design for the site that is maintained throughout the site navigation, content and features. Employs a variety of methods to present conceptual designs/solution (wireframes, mock-ups, detailed visual designs, and graphics).
Requirements:
- Bachelor’s Degree in Management Information Systems, Business Administration, Computer Science or equivalent experience
- Minimum 5 years’ experience in web user interface design and web application development with management responsibilites.
Summary:
The Senior Web Designer is responsible for the design, development and maintenance of web applications and components. The primary focus is to support and maintain the envato.com public web site. A deep understanding of the site architecture (both functional and technical) and how it supports the business vision and processes will be vital. Will identify, design and implement web site enhancements by working closely with a team of internal marketing/sales stakeholders, and with external digital ad agency and application vendors. Adheres to KBHIT processes/methodologies including request management, application development and release management.
Duties and Responsibilities:
Works closely with a team of internal marketing and sales stakeholders as well as with and external digital ad agency and application vendors to define a compelling design for the site that is maintained throughout the site navigation, content and features. Employs a variety of methods to present conceptual designs/solution (wireframes, mock-ups, detailed visual designs, and graphics).
Requirements:
- Bachelor’s Degree in Management Information Systems, Business Administration, Computer Science or equivalent experience
- Minimum 5 years’ experience in web user interface design and web application development with management responsibilites.
LOCATION: BURLINGTON, MA
DURATION: 6-12 MONTH
JOB TYPE: FULL-TIME/ CONTRACT
Following are the core skills required to assist and supplement the client’s team with implementation of various security initiatives that include:
Network Segmentation and standardization of enterprise firewalls – Check Point & Palo Alto
Network Access Control deployment expansion and improvements – Portnox
Identity Access Management
Migration from Cisco ACS to Cisco ISE
Expansion of two factor authentication deployment – Gemalto
Remote Access VPN technology deployment and configuration – ASA & Cisco AnyConnect
Web Filtering design and efficiency improvements – WCCP & Forcepoint
Incident Response event investigation and recovery support
Current team activities include the support of existing projects and operations (F5 WAF & LB, Forcepoint web filtering, overall email hygiene, Skype expansion, AntiVirus, cert management, vulnerability scanning, VPNs) and preparation for upcoming initiatives (SIEM refresh, Firewall refresh, Advanced endpoint AV, F5 VPN migration)
LOCATION: MEMPHIS,TN
DURATION: 12-24 MONTHS
JOB TYPE: FULL-TIME / CONTRACT
PAY RATE: $25-35 PER HOUR
Provides analytic consultation, training and support to business users, leadership or external customers.
- Strong Customer Service/communication skills required. Ability to gather report requirements, create documentation and train users with a wide range of technical ability.
- Data Visualization experience required. Experience with open source or commercial visualization tools like Tableau preferred.
- May require using SQL/SAS/Hadoop or open source tools such as R and Python to create, maintain and manipulate databases to track business performance.
- Develop and analyze business performance reports (e.g. for claims data, provider data, utilization data) that identify performance deviations and anomalies and make recommendations based upon data analysis.
- Analyze data and summarizes performance using summary statistical procedures.
- Support the creation of periodic reports, as well as any necessary ad hoc reports.
- Strong analytical, organizational and problem solving skills.
Healthcare experience strongly preferred.
May require taking business issue and devising best way to develop appropriate diagnostic and/or tracking data that will translate business requirements into usable decision support tools.
LOCATION: MILFORD.CT
DURATION: 12-24 MONTHS
JOB TYPE: FULL-TIME / CONTRACT
PAY RATE: $35-50PER HOUR
- Participate in business discovery sessions; gather business requirements and preparing functional documents.
- Prepare mapping documents for the inbound & outbound SAP interfaces.
- Configure all purchasing activities, number ranges, documents types etc.
- Responsible to carry out cut-over/MTP (move to production) activities and go live support.
- Analyze the current business processes and scenarios of the client and recommend/develop solutions to meet the clients need.
- Responsible primarily for successful implementation of SAP, providing functional expertise, guidance, presentation, and instruction on SAP products to clients.
- Manage or participate in SAP Business All-in-One implementations.
- Acts as liaison with client for troubleshooting: investigate, analyze, and solve software problems and map client business requirements, processes and objectives; develop necessary product modifications to satisfy clients needs.
- Maintain a thorough knowledge of the organization and adhere to all organizational standards.
LOCATION: CHERRY HILL,NJ
DURATION: 12 MONTHS
JOB TYPE: FULL-TIME / CONTRACT
PAY RATE: $25-40 PER HOUR
- Maintain a reliable, secure and efficient data communication network.
- Assists with the daily administration and troubleshooting of the network, wireless network, and firewall environments. Resolve tickets and provide diagnosis of issues.
- Performs routine updates and maintenance tasks for time-critical problems.
- Install, configure, and support an organization’s local area network (LAN), wide area network (WAN), and Internet systems or a segment of a network system.
- Should be able to deploy, configure, maintain and monitor all active network equipment in order to ensure smooth network operation.
- Monitor network to ensure network availability to all system users and may perform necessary maintenance to support network availability.
- Works under the direct supervision of high-level engineers to develop and recommend solutions for problems.
- Provide interim solution implementation until the problem cause and resolution can be determined and mitigated.
- Install and integrate new server hardware and applications, Monitor network performance (availability, utilization, throughput, goodput, and latency) and test for weaknesses.
- May monitor and test Web site performance to ensure Web sites operate correctly and without interruption.
- Set up user accounts, permissions and passwords, Define network policies and procedures.
- Assist in network modeling, analysis, planning, and coordination between network and data communications hardware and software.
- Diagnose, troubleshoot, and resolve hardware, software, or other network and system problems, and replace defective components when necessary.
- Monitor system resource utilization, trending, and capacity planning
- Provide Level-2/3 support and troubleshooting to resolve issues
- Work within established configuration and change management policies to ensure awareness, approval and success of changes made to the network infrastructure
- Select and implement security tools, policies, and procedures in conjunction with the company’s security team
- Liaise with vendors and other IT personnel for problem resolution.
LOCATION: RIDGEFIELD, CT
DURATION: 12 MONTHS
JOB TYPE: FULL-TIME / CONTRACT
PAY RATE: $25-35 PER HOUR
- Directly responsible for ensuring those adverse events are processed, analyzed and reported according to Corporate SOPs, local working instructions and local regulatory requirements.
- Responsible for distribution and retrieval of data to internal and external customers as needed for analysis and compliance with regulations.
- Serve as point of contact with clinical team in areas of adverse events process.
- Assist with collection, processing, and reporting on adverse event reports.
- Pharmaceutical Industry experience.
- Must possess solid understanding of federal regulations as they apply to drug surveillance for both IND and NDA reporting.
- Strong communication skills required in order to facilitate report preparation, participate in working groups and interact with a variety of departments.
- Experience with computerized data entry and retrieval as well as other computer based applications (word/excel) is also required.
Skills
Education
BS degree or higher in nursing, pharmacy or related health care field (preferred) and a basic knowledge of clinical medicine
LOCATION: Uniondale, NY
JOB TYPE: Full Time / 40 hour per week
- Development of novel methodologies for amplification and detection of nucleic acids using real-time PCR approaches.
- Improvement on current nucleic acid practices and techniques at Exact Sciences (e.g.,extraction, bisulfite conversion, cloning, purification, amplification,detection).
- Evaluation of new nucleic acid platforms and chemistries. Improvement on current methods of real-time PCR data analysis.
- Employing statistical methods in data analysis and results interpretation. Tackling a wide range of applications where innovation, creativity, and problem solving skills are used.
- Manage research projects and supervise a team of research scientists. Plans and executes new research projects. This includes researching the subject, defining an experimental plan, preparing protocols, performing statistical analysis and interpretation of data and results, and prepares reports.
- Maintains knowledge of scientific technological developments that may assist in the completion of an assignment or lead to new products, processes or procedures by reading current literature. May attend technical conferences or seminars.
- Contribute to the intellectual property portfolio of the company by implementing innovative and creative ideas to solve problems or improve on current methods used.
- Support drug discovery efforts for immune modulatory agents in murine models of disease working closely with project teams and in collaboration with internal and external partners
- Perform in vivo studies, tissue and primary cell sample preparation (mouse and human)
- Provide support for novel ex vivo assay design/development and analysis using ELISPOT, flow cytometry and/or multiplex assays to evaluate the immune response
- Assist in documentation and organization of data, generation of technical reports and presentation of findings to project teams
- Ensure seamless execution of work flows by: tracking animal/supply orders, making recommendations to improve procedures and protocols, making sure equipment is in working order, maintaining accurate records of all data and procedures
- Play a key role in performing technical laboratory processes, including training on existing assays and clinical testing related activities as per schedule and under management discretion in a GCLP environment
- Required to perform routine assays with high sample throughput and to record all data in specified formats (including electronic) following Good Documentation Practices.
- Additionally responsible for activities related to assay development including optimization and validation of assays, will assist the Laboratory Lead or above with analysis and interpretation of clinical and/or experimental data
- Ensure that corporate, quality, regulatory and safety procedures/requirements are being observed and followed at all times. Maintain accurate inventories and will be responsible for informing lab support about ordering supplies.
- Responsible for drafting SOPs, writing reports and presenting data in various formats, and for performing HAI assays as per Manager’s direction. Will also responsible for performing Cell Culture activities as per Manager’s direction.
- Manages lower level scientists, including providing technical guidance,interviewing, hiring, training, goal setting, including performance evaluation, prioritization of work and compliance with personnel and safety policies.
- Presents experimental results and contributes ideas to improve team processes.
- Reports status of assigned projects through the preparation of detailed reports and documentation that summarize experiment results. Interprets results of experiments and recommends alternative experiments.
- Participates in technical decisions affecting research and development issues.
- Presents information at project meetings and may present findings at scientific meetings or to customers. May prepare and/or contribute to articles for publication.
- Supports and complies with the company’s hazardous waste management program, including following safe, hazardous waste handling practices.
- Maintains lab notebook in a complete and consistent manner, following all legal, ISO and QSR requirements as well as keeping clear and complete records.
- Performs other related duties as assigned by management including providing backup for departmental coworkers
- Must have an in-depth experience (hands on and theoretical) with nucleic acid amplification, quantification, and modification methods (i.e., qPCR, TaqMan, Molecular Beacons, Invader, LAMP, TMA, RCA, LCR, etc.)
- In depth experience (hands on and theoretical) in nucleic acid and molecular biology techniques (e.g., real time PCR, DNA/RNA extraction and purification) and nucleic acid epigenetics and bisulfite conversion chemistry.
Education
Bachelor’s Degree in Biology or Biotechnology
Skills Required
Experience with GMP/GLP, testing technologies, QPCR, sample quantitation, PCR, RT-PCR, hybridization, DNA amplification etc.