IT Trailblazers, LLC

Candidates can work remotely until COVID-19 lockdown ends and post that should be working on-site. Must have Active / Interim Secret Clearance Job Key Responsibilities: Build new cloud-based data center services environments for DoD cloud initiatives. Serve as overall subject matter expert on Cybersecurity Policy Administration. Work between technical and policy teams to implement, maintain, and monitor technical security configuration controls, including STIGs, SRGs, and other industry security hardening guidance. Work between technical and policy teams to successfully implement and manage requirements for maintaining cloud P-ATO, ATO, and security control inheritance capabilities. Collaborate with internal and external parties to transform high-level technical objectives into comprehensive technical requirements. Act as the IASO for hosted systems, assuming the responsibilities as outlined in AR 25-2. Assist hosted customers in obtaining and maintaining RMF for DOD IT and other certifications as required. Update and/or assist the hosted system's personnel in updating artifacts of the accreditation package and store the artifacts in the organizationally defined repository, i.e., system diagram (logical and physical) Hardware/Software/Firmware Inventory, Interface & Ports, Protocols and Services listing, etc. Assist in the preparation of network infrastructure specifications or designs incorporating required information security features. Review and evaluate Information Systems Design Plans, Continuity of Operation Plans, Communication Plans, engineering change proposals, and configuration changes for compliance with relevant security regulations, policies, and best industry practice. Job Must-Haves: 3-5 years of experience as a Cybersecurity Policy Administrator Mid to senior-level Cybersecurity Policy Administrator experience in a cloud environment Experience automating routine administrative tasks desired Understanding of network, storage, server, and application technologies Working knowledge of DoD STIGs, and IA Vulnerability Management (IAVM) DoD 8570.1M IAM level II (i.e., CISSP) certification is required Computing Environment (CE) Certification (i.e., MCSE, Server+, etc.) can be waived for 30 days after the project join date. Strong verbal and written communication skills Experience effectively managing multiple large-scale projects DoD Secret clearance or a minimum of Interim Secret clearance. - provided by Dice

Candidates can work remotely until COVID-19 lockdown ends and post that should be working on-site. Mandatory Skills: PEGA LSA, Smart Dispute exp. Experience Needed: 10+ years Responsibilities & Key Skills: Architecting and designing business applications using Pega PRPC and other Pega frameworks Provide thought-leadership to client across business and technical project dimensions solving complex business requirements Works in conjunction with VP, ED to manage scope and risk Accountable for ensuring the business and technical architecture of the delivered solution matches customer technical and functional requirements, and commits to Customer Success (realization of business benefit) Participates in the development of additional consulting opportunities within the customer base Well experienced with design application and Infrastructure using various Application Servers, Databases, Security Managers, etc. Expertise on various integration technologies like SOAP, REST, MQ, TCP, HTTP Strong understanding of Application Security Well versed with SDLC, Agile, CD&CI methodologies. - provided by Dice

Hi, Hope you are doing well This is Surya from ITT Blazers. We have an urgent position with one of our global clients for a Salesforce BA. Please review the below Job Description and let me know if you are interested Role: Clinical Data Manager-Senior Client: Immunomedics Location: Remote - Remote Candidates will be considered. Eastern Time Zone preferred; Central Time Zone considered. Will be required to travel to Morris Plains, NJ office for meetings as requested. Job Type: Contract Duration: 18 Months Visa: Any Visa is fine GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION) This position requires a sound working knowledge of clinical data management processes and database systems within a multi-disciplinary team environment. ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES) Performs clinical data management functions in support of clinical studies. Functions to include some or all, but not limited to: data review, protocol review, case report form (CRF) design and creation, CRF review, data entry, database validation, query generation, and validation of study results. Assists in training new employees, including temporary data management personnel. Supervises and monitors team member performance to ensure the timely and accurate fulfillment of assigned duties and tasks Assists with review, creation and/or updating of departmental documentation including but not limited to SOPs and training guidelines. Coordinates with clinical study personnel to provide timely feedback on data issues for resolution by investigational sites. Jointly with clinical study personnel, develops and prioritizes appropriate timelines for the completion of databases required for submission, report writing, and/or presentation purposes. Interacts with external laboratories in coordination with clinical study personnel to ensure that appropriate laboratory evaluations are being collected in accordance with protocol requirements and consistent with c====P and/or approved SOPs. CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES) Must have a good understanding of CRF and clinical database structures, and data management processes including CRF review, data analysis, data validation, data quality, and query generation and resolution. Knowledge of MS Excel, WORD, ACCESS, and PowerPoint is essential. Individual must have good analytical, communication and personal skills, be well organized, and a good team player. Knowledge of MedDRA coding, CDISC standard, or SAS would be a plus but not mandatory. EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL) Bachelor's degree in life science/biomedical/medical science with a working knowledge of the clinical/scientific terminology and methods common to the biopharmaceutical setting. Minimum of at 5 - 10 years of relevant experience working in a clinical research environment within biotech/pharmaceutical/CRO or healthcare setting preferred, with basic understanding of the clinical development and data management processes; or equivalent combination of education and experience. - provided by Dice

Hi, This is Surya from ITT Blazers. We have an urgent position with one of our global clients for a Digital Project Manager. Please review the below Job Description and let me know if you are interested Title : Regulatory Lead - Oncology Start Date : 10/19/2020 End Date : 04/17/2021 Location : Morris Plains, NJ, United States Description : GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION) Responsible for providing global and FDA regulatory strategic guidance to clinical development teams with regard to regulatory requirements and health authority interactions. Support regulatory clinical study filings, leading and preparing teams in seeking Agency advice and maintaining compliance with reporting requirements such as DSUR, Orphan drug, PSP, annual reports, etc. Acts as Company Liaison for Health Authority interactions. ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES) • Development of and excellence in execution of regulatory strategy and tactics • Effectively lead and direct interdisciplinary teams for regulatory activities • Act as a liaison with worldwide health authorities and maintain highly effective relationships with them through exceptional written and verbal communication skills. Leads FDA meetings and fosters a positive relationship on behalf of the company • Plans and prepares regulatory submissions for Clinical Trial Applications (CTAs)/Investigational New Drug (INDs) Applications • Monitors due dates for all reports and regulatory commitments • Prepares official Company responses to regulatory agency questions • Leads in the preparation and implementation of health authority meetings. • Interacts with Clinical Research Organizations and licensing partners regarding regulatory purposes. • Keeps abreast of the global regulatory environment and regulations It is each employee's responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee's responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function. - provided by Dice

Title : Regulatory Operations Specialist Start Date : 10/19/2020 End Date : 04/17/2021: Location : Morris Plains, NJ, United States Description : Remote Candidates Will Be Considered. GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION) Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables ensuring submissions are of highest quality and delivered on-time. The position will also archive and track regulatory correspondences, documents and submissions. ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES) • Electronically formats, publishes electronic documents and builds Regulatory submission deliverables and ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures. • Provides guidance on good documentation and submission practices to project teams. • Archive (categorizing and classifying information) all Regulatory records pertaining to multiple Regulatory Applications (e.g., IND, BLA, CTA), maintaining Regulatory Application indexes, tracking of regulatory submission documents, and special projects as needed. CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES) • Good understanding of applicable FDA and ICH guidelines related to regulatory submissions • Good understanding of eCTD publishing systems, EDMS technology and authoring tools and templates. • Clear understanding of regulatory submission content and format requirements • Experienced in lifecycle management eCTD submissions including but not limited to, IND Safety, and IND Investigator submissions • Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills. EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL) • 5-7 years of experience • BA degree preferred - provided by Dice