- Senior Quality Management experience (10+ years)
- IT infrastructure qualification experience
- SAN experience
- Novartis experience (preferred – but not a must)
- Immediately available (i.e. within a couple of weeks) in New Jersey/East Hanover
Reporting to GM
Reason for job opening: Client has a need for support to the PM ensuring Quality level in project with experience in SAN storage solutions
Qualifications:
- 4-7 years experience in project coordination and/or management. – Project Management Certification Skills: General knowledge of clinical trial research (Pharmacogenomics experience preferred); Understanding of core LEAN Six Sigma or other process optimization methodologies; Strong verbal and written communication skills; Collaborative; Organized; Takes initiative/self-starter; Attention to detail (completeness and accuracy); Proficiency in MS Office (Outlook, WORD, PowerPoint, EXCEL), Sharepoint and Visio (Process Mapping); Flexibility / willingness to provide “quick turn-around” on short notice to meet deadlines highly desired
Responsibilities:
Support existing departmental processes (e.g., coordinating dept. participation in investigator mtgs, coordinating certain dept meetings [including agendas and minutes]); Support maintenance of key documents (cross-functional GRDP, internal business practices (IBP), department training plan, and other training materials); Monitor deliverables (timeliness and quality) from sourcing partners; Support further departmental process optimization (e.g., proactive coordination and tracking, error-proofing, process mapping, new SOPs or IBPs, identifying departmental “pain points” and opportunities to improve quality of work, developing communications and implementation plans, monitoring); Provide routine status updates (e.g. quarterly metrics)
Summary:
Responsible for deploying software to end user devices globally and ensuring success.
Management of the entire project.
Communications to end users in advance.
Follow up to ensure satisfaction.
Deskside support for issues.
Coordination of training.
Skills/Knowledge Required:
Altiris software deployment.
Technical Project Management experience.
MS Lync.
Customer focus.
Communication and end user technical support/satisfaction experience.
Windows XP / Windows 7 knowledge required.
PREREQUISITES Strong IT experience
Strong presence with senior management
Strong relationship development skills
4 year degree, graduate degree a plus
Summary: The Senior Business Analyst, IT – Global Business Partnership team will act as a liaison between IT and key requirements stakeholders. Candidate must have excellent client-facing skills, superior documentation and technical skills, and must possess the ability to think, write, and work independently.
The candidate should have at least 8 – 10 years of general business analysis experience, hands-on experience with UML, developing Use Cases, and performing Use Case, Sequence, and Activity diagramming as well as Business Process Mapping. The candidate should have exposure to requirements management tools such as BluePrint Requirements Center, Requisite Pro, or something similar.
The candidate will work closely with technical teams, the project manager, and with the Global Marketing team in the ongoing efforts to build out an enterprise data warehouse and reporting system for the Global Marketing division. The Senior Business Analyst will also play a key role in a variety of data acquisition and integration efforts, including soliciting and documenting requirements through to test plan and test script design and project delivery. Candidate must also possess a thorough knowledge of marketing and financial concepts and key performance indicators (KPI’s) for the global Hematology and Oncology markets.
“ Ability to engage in new subject areas and quickly establish understanding and credibility with the goal of collecting and documenting detailed data and reporting requirements from a variety of stakeholders
“ Validate, analyze, and document detailed business requirements; identify gaps between system capabilities and business requirements; and map capabilities to requirements to ensure that business needs are met
“ Assist in the creation, review and approval of functional system designs for new and updated product/service capabilities
“ Assist in the translation of business requirements into test conditions and expected results for product, performance, and user acceptance testing (UAT)
“ Develop and manage data to be utilized for UAT test cases
“ Maintain and update documentation as changes in systems and business processes occur
“ Work with Project Manager to resolve prioritization challenges
“ Assist with the development and execution of Change Management and training throughout the organization during the Implementation projects
“ Clearly document business needs via business requirements gathering automation tools to define use cases, report design specifications, and data flows
“ Document current state of data and reporting and plan the future state for business process
“ Minimum of 8 – 10 years experience as a technical or business analyst in the development of an enterprise data warehouse with familiarity in data warehousing concepts
“ Excellent verbal and written communication skills and the ability to provide effective status communications to multiple levels of the organization
“ Familiarity with the following data areas:
“ Global Financial Budget and Actuals
“ Patient Duration
“ Market Share
“ Brand Forecasting
“ Dispense/Rx Data
“ Forecasting Data
“ Ability to write queries to select data sets from disparate data sources including Oracle, SQL, Access, Business Objects Desktop and Web Intelligence, and other tools
“ Strong attention to detail and the ability to engage personally with stakeholders as well as manage globally distributed teams
Skills/Knowledge Required: Please make sure your candidate has strong knowledge of the following:
“ 8 – 10 years’ experience as a technical or business analyst role in a data warehousing environment
“ Experience in marketing reporting and KPI’s
“ Demonstrated familiarity with Business Intelligence tools specifically Business Objects Desktop and WebI
“ Proven track record of creating User Requirements Documents, Test Plans, and Test Scripts
“ Demonstrated Business Process Management (BPM), Business Rules Engines or Process Automation
“ Project management experience
“ Knowledge of the SDLC for both COTS and Custom Build
“ Extensive knowledge and familiarity with BABOK
“ Experience in the management of distributed project teams
“ A desire to help our clients successfully meet their goals by helping them deliver on their project
“ Senior-level experience with the following software:
“ Blueprint Requirements Center
“ MS Excel, Word, Access, PowerPoint
“ Business Objects Desktop and WebIntelligence
PREREQUISITES Technical degree preferred; 10 years’ full-time Linux systems design and administration experience in a corporate environment is required.
Summary:
The responsibilities of this position include, but are not limited to, Implement, Deploy and support of Linux Infrastructure activities with specific emphasis on design and Implementation of new systems and its integration to the Infrastructure in place on our Corporate Data Centers and remote office locations. The Linux Systems Engineer, will have the ability to research, design and implement hardware and software solutions.
Responsibilities will also include, but are not limited to, the following:
“ Installs and configures Linux Red Hat 5.5 operating systems on newly acquired hardware.
“ Manage technical infrastructure and support, including local and satellite offices
“ Configure new servers while documenting the implementation.
“ Configure and support RedHat Linux virtualization and KVM
“ Follow standard operating procedures while maintaining validated servers.
“ Assist with the installation of off-the-shelf applications and document the installation procedures.
“ Provide Customer support via telephone, e-mail, and other tools.
“ Provide timely status updates to Engineering manager and other IT management
“ Perform other job related duties as required
“ Helping to lead other systems engineers and systems analysts
“ Be responsible for storage area network design/implementation/management for Linux systems
“ Resolving technical issues when needed
“ System and application backups and recovery of Linux systems
“ Administer IBM SAN utilizing Linux LVM
“ Write custom tools to automate system administration tasks, backups, monitoring, etc.
“ On-call support on some nights and weekends and supporting on-site or remotely may be needed.
Skills/Knowledge Required:
“ 7+ years of Red Hat Enterprise Linux Admin experience on a Corporate Environment
“ Experience Installing, supporting and managing Red Hat OS on IBM Server booting of the SAN.
“ RHCE certification is a must
“ Experience in a high-volume or critical production service environment required
“ Experience with High Availability, Clusters failover scenarios and load balanced environments.
“ Red Hat GFS and NFS configuration and implementation for Oracle RAC, expertise are a must.
“ Strong knowledge of TCP/IP and various Internet servers (DNS, HTTP/HTTPS, SSH, SNMP, NFS, MTA’s, SAMBA, etc.
“ Familiar with Red Hat best practices, security and server hardening
“ Experience with a scripting language (Perl, Python, Shell, and or PHP)
“ Experienced on RedHat Linux Virtualization is required
“ Experienced working with development teams, engineers and vendors designing large systems.
“ Familiarity with Oracle and SQL databases and web programming languages
“ IBM xSeries & Blade Server administration experience strongly desired.
“ Strong working knowledge of IBM storage environments (SAN,NAS)
“ Excellent communication, written and organizations skills are required
“ On-call support on some nights and weekends and carrying a cell phone are required. Occasional late-night maintenance, alone at the corporate facilities, is required.
“ Must be able to physically lift and move computers, storage and peripherals.
Education/Experience:
“ Bachelor’s Degree or equivalent experience with at least 7 years of experience administering, monitoring and managing Red-HAT Enterprise environments.
“ 7+ years of experience building Jumpstart and Kickstart automated server installs.
“ At least 5 -7 years of experience of Enterprise capacity planning skills with be a plus.
“ Over 5 years of experience with high-availability and Disaster-Recovery using technologies such as Cluster Services, SRDF/BCVs are a must.
“ Experience with TSM for the Linux operating system.
“ Over 5 years of experience automating, activities using Perl and Shell scripting is a necessity.
“ Demonstrable experience with the administration or setup of Oracle/Sybase/SQL is a plus.
“ Demonstrable experience administering, setting-up or participating in initiatives with application servers such as JBoss, Weblogic and Websphere is a plus.
“ Experience with VMware 4.x Virtualization is preferred
“ Pharmaceutical background preferred. Understanding of the CFR Part 11 and Sarbanes-Oxley regulatory requirements and experience with processes and procedures to apply and administer these and other necessary regulatory requirements in an operational environment.
“ Linux to Active Directory integration experience strongly desired.
“ Demonstrated ability in staying abreast of technical developments in the industry and aligning them with strategic company objectives
“ Organizational “Fit” Considerations: The candidate must be flexible to take on different tasks at short notice and have the ability to function in cross-functional team setup that consists of different disciplines. Prospective candidate must be able to work in a fast paced environment.
Prepare computer validation documents such as Validation Plans, User Requirements, Configuration Specifications, Test Protocols, and Summary Reports. Prepare Change Control documentation. Execute test scripts. Perform risk assessments. Must be familiar with 21 CFR Part 11. Consult on Projects. Prepare Project Plans.BS in a technical field and 5 years experience in GxP environment.
Requirements:
1) Extensive Pharmaceutical Experience.
2) Extensive experience (10 years plus) in writing IT system validation
protocols including IQs/OQs/PQs, project summary report. Will consider candidate 5-7 years.
3) Deep understanding of SDLC and IT/system change management processes.
4) Experienced in writing system implementation project related
documentation such as project charter, implementation plan, communication
plan, risk management plan.
5) BS degree required. Masters?s degree preferred.
Looking for someone who has recently been working in a regulatory environment.
On-site at least 2 days/week—so, commute is a big deal.
No journal, medical education or academic writing, or freelance writers.
Staff augmentation role—looking for committed people.
Expect writing multiple revisions and lots of writing.
They want writers more than they want scientists/medical professionals.
Team oriented.
Original spec:
Work directly with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents. Responsibilities include prepare regulatory documents on behalf of client in accordance to ICH guidelines, international regulations, client standards and processes, and the client Writing Style Guide as applicable. Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, addenda, errata. Investigator brochures, new drug advisory submission documents. Participate in clinical study and project team meetings to provide input regarding deliverables, timelines, and processes needed. Administer, the receipt, collation, and incorporation of review documents. Route documents for approval. The medical writer should be familiar with ICH guidelines and the AMA Manual of Style, 10th edition. The writer will be asked to format and manage long documents with multiple review cycles and tight deadlines.
Qualifications: Excellent writer, good organizational and communication skills. Strong attention to detail. Proficiency using eDMS. Strong analytical ability to interpret clinical data. 7 years writing exp in pharma industry. Bachelor’s degree in life sciences, RN, Master’s degree in life sciences, PharmD or MD preferred. Can work remotely but must work 2 days min onsite. Excellent writing skills, compulsive attention to detail, proficiency using an electronic document management system, and strong analytical ability to interpret clinical data. Experience: 7 years’ writing experience in the pharmaceutical industry.. A copyediting test will be required during the interview
Please take note this is a FULL time 40 hour work week. Must work onsite min of 2 days.
1) Medical Writers should use AMA style for the text and Vancouver style for any references or citations.
2) We are looking for someone with several years’ experience working as a MW inhouse at a major Pharma. Experience with an academic institution does not translate.
3) Please do not alter your job seeker’s resumes. We want to see original content and original resumes.
Seeking a well-organized, collaborative person, experienced in program and project management to perform integrated planning and project administration for ongoing programs. Experience operating within a PMO or working utilizing a mature PMO?s methods and tools is required. Specific experience in using MS Project to create multi-project rollups and resource loading is also required. Demonstrated experience with managing budgets (labor, capital, expense) is also required. This individual must be able to report to a Program Manager, providing weekly and monthly planning, status and budget tracking and reporting.
The candidate must have at least two years of experience in this specific role, and five or more years of experience working in an IT setting managing projects. Strong communications and interpersonal skills are required.
Work as a planning, status reporting and budget management resource on multiple programs. Act as an assigned resource from the PMO to support at least two active programs. Work with global teams setting up planning sessions, status reviews and facilitating the input of data into the PMO’s portfolio management system. Perform a variety of miscellaneous coordination and communications tasks.
As an associate reporting into IT, the incumbent will be required to work collaboratively with across Global IT associates, Corporate Quality Management and Corporate Regulatory Affairs on both the validation of new systems as well as the improvement of existing IT Quality Processes and/or practices. In this highly visible role, the Validation Engineer will be required to provide validation support and guidance on a variety of system validation projects and production environment changes. Additionally, the incumbent must be capable of identifying and communicating any FDA/ISO/SOX compliance risks within existing IT work processes and/or existing production systems. The incumbent MUST be a subject matter expert of the SDLC methods as they relate to Computer System Validation, IT Quality Systems and Technology in general. Scope of business applications to be potentially supported will range across GMP, GCP and GLP regulatory areas. Scope of role is additionally inclusive of both application and infrastructure validation responsibilities. Further responsibilities include supporting and maintaining the validated state of Validation Document Mgmt. tool set.
Primary Responsibilities: Conduct Quality review & approval of Validation Deliverables, including: Validation Plan Computer System Assessments 21CFR Part 11 Assessment Test Plans Risk Assessments Test Summary Reports
Skills/Education Required: must have computer system validation experience
Work Experience: minimum of 5 years of experience required
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