desktop support
New York, NY job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Job Title:
DESKTOP Support Representative
Job ID:
#
S2LF2Q
Location:
new York ,NY 10036
Duration:
: 1 year (with possible extension)
·
Candidates should be able to diagnose and remedy complex Microsoft OS problem tickets, configure and install common applications and install/remove desktop PCs and monitors.
·
Installation, configuration and maintenance of windows, hardware's and software's.
·
Desktop and laptop installation ,configuration and upgradation
·
Functional knowledge of MAC , Windows client / server configurations, software, connectivity, troubleshooting,
·
Support and troubleshoot windows XP and windows 7/Migrations
·
MS Office, MS Outlook and Microsoft Products.
·
Remote / CTS Support, SCCM, Windows, Incident, IMAC, VDI, SW/Break/fix, IMAC, Ability to solve tickets remotely, work with SCCD.
Additional Information
For more information, Please contact
Shubham
************
Business Operations Specialist
New York, NY job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Title: Business Operations Specialist
Location: New York, NY
Duration: 6-12 Months (Contract to Hire)
Required:
Experience in application reporting tools, such as Tableau
Have knowledge of salesforce or any other CRM tool, has ability to learn the tool
Understanding of business analysis background
Taking the information coming into case
Organized analytical and self-starter.
Someone from data analytics background.
Understanding data from dashboard
NO PMP, but project management background is useful
Qualifications
Top 3 skills:
Organized
Analytical
Reporting
Additional Information
For more information, Please contact
Pankhuri Razada
Associate Recruiter
Artech information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 Morristown, NJ 07960
************
[email protected]
Global Brand Medical Director
East Hanover, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job DescriptionMedical Affairs leader for assigned compound(s) and /or project(s under the leadership of a Sr. GBMD or GMA Franchise head.
Major Activities:
For assigned compound/indications, work collaboratively across functions, within GPT to execute an integrated Medical Affairs plan including clinical trials, publication, medical education and medical information.
Manages all operational aspects and drives execution for assigned projects of Global Medical Affairs clinical trials in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates.
Participates and contributes to the joint ICT s.
Provides Medical leadership to CTT s for Client sponsored GMA trials
Leads review of investigator-sponsored trials and Local/Regional Medical Affairs trials concept sheets, within MRC, for assigned projects(s).
Provides medical support for educational events (e.g. stand-alone meetings, scientific symposia) and scientific congresses within legal and compliance regulations.
Collaborates across functions to achieve approval of key scientific communications, medical information documents and commercial documents within NP4 legal and compliance regulations.
Skills:
Fluent oral and written English.
Have expert operational knowledge and experience in clinical trial design and all stages of clinical trial conduct (Trial design, Start-up, Execution, Analysis, Reporting).
Have an excellent knowledge of current clinical practice in Oncology / Hematology / Endocrinology or other relevant disease area.
Have strong knowledge in and understanding of medical activities (including scientific communications, medical information, MSLs, and HEOR), relating to the commercialization of oncology products.
5 years experience in pharma at local, regional and/or Global level.
Provide medical expertise to ensure successful product launches across functions.
NVS sponsored trials
Review and coordinate IITs
Implement patient access programs
Review promotional materials & publications
Integrate medical expertise with commercial perspective.
Maintain an external focus to optimize and maximize treatment options and compound life cycle management.
Timely implementation and delivery of high quality Medical affairs clinical programs within budget, in full compliance with Client Standard and GCP/ICH.
Well managed and effective clinical teams.
External satisfaction, acceptability of clinical data by key decision makers including health authorities, payers.
Development of high-quality scientific communications and medical information.
Strong alignment between Global and Regional/local medical organizations.
Strong alignment within global line functions.
More than 4 years advanced knowledge in medical/scientific area (Oncology, Hematology, Endocrinology) preferred.
QualificationsEducation:
MD Required
More than 4 years advanced knowledge in medical/scientific area (Oncology, Hematology, Endocrinology) preferred
Additional InformationNeha Sharma
Lead Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
Website: ******************
Brand Safety Leader
East Hanover, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Development of processes and identify and qualify new business opportunities. This role links closely with R&D to leverage technical possibilities and understand technical trade-offs vis a vis market potential. Works closely with market research group to Client new consumer/ patient insights. As initiatives advance toward market launch, this role will also support the development of the winning consumer & ECP big idea, and lead concept, claims, key benefit and RTB visuals, as well as any relevant sights & sounds cues. It is crucial the candidate has global experience as well as innovation, new product development, and/or new product launch experience. This individual must be proficient in market landscape assessment, analyzing diverse market segments and providing recommendations on new market opportunities. This position also supports Client&L in the scouting and due diligence processes with market assessment, conception and financial calculations.
1. Responsible for safety issue management from end of Phase I (POC) through Life Cycle Management.
2. Accountable for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post marketing data, and other sources.
3. Accountable for developing and updating, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management, as relevant. Accountable to ensure adequate risk management plans are in place.
4. Leads Safety Management Team.
5. Serves as safety representative as core member of Global Program Teams. Manages Drug Safety Monitoring Board activities for assigned projects/products, as required.
6. Accountable for responses to inquiries from regulatory authorities or health care professionals on safety issues. Accountable for safety data for health authority review boards. Accountable for responses to legal queries and CPO requests involving safety issues. Ensures safety information communicated to EU Qualified Person in a timely fashion. Coordinates product-specific activities.
7. Accountable for integrated safety input into all safety relevant parts of regulatory and company documents (i.e. IB, CDS, SCS, RMP, SPP, CO, PIP, GDPS, CDP, etc.) required during active development, submission phase and during marketing phase.
8. Review of medical safety input into study protocols (including MRC and OPCE) MAP, RAP and ICF.
9. Review/approve product-specific safety deliverables: IN letter, PGD, data searches, literature review, expert statements.
10. Coordinates involvement of external experts (e.g. authors of "white papers," members of trial-specific data safety monitoring boards, ad-hoc support for HA meetings, etc.
11. Accountable for presentations on project/product safety issues to internal Client Boards, or expert panels and other meetings.
12. Collaborates productively and manages in a cross-functional matrix team environment (e.g., SMT).
13. Assist in training of new hires (e.g. new BSLs) and mentor/coach direct reports (PVL/PVE) as required.
14. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
15. Serves as and performs activities of Pharmacovigilance Leader such as ad-hoc medical case review as needed.
Skills:
Three years medical experience postdoctoral
o At least five years in industry or health authority or CRO (of which two years in a global position), including a minimum of three years in drug safety
o Experience in preparing clinical safety assessments, risk/benefit evaluations and regulatory reports
o Experience in leading cross-functional, multi-cultural teams
o Experience in preparing RMPs, PSURs, submission dossiers (SCS)
Qualifications
MD Required
Additional Information
Thanks
Richha Saini
Technical Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
"2014 Service Excellence Award Winner from J&J"
Sr. Medical Data Specialist
Woodcliff Lake, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description:
•
Must have at least 5 years of both coding and clinical data review experience who can support one of our submissions.
Responsible for the selection and review of appropriate codes of reported terms in clinical trials not limited to adverse events, medical history and medications.
•
Ensures that the term is clear, appropriate and complete as per investigator s entry on the CRF otherwise, he/she is responsible for the coding query.
•
Abstracts all necessary information from other CRF pages for concept coding if necessary. Assigns codes using MedDRA and WHODD terminologies, which most accurately describe each panel according to established coding guidelines and conventions.
Performs reconciliation of safety report and clinical patient profile. Post queries for relevant information from safety report to be added in the clinical database. May require narrative writing for clinical data review profile.
• Quantitative analysis Performs a comprehensive review for the all the reported and coded terms. To assure the presence of all coding targets not limited to LLT, PT and SOC and Trade name , Preferred Name ATC 2 and ATC 4 and their respective dictionary versions. Completes brief description of clinical cases for clinical data review utilizing the autogenerated narratives.
• Qualitative analysis- Evaluates the record for coding consistency and adequacy. Ensures that the selected codes accurately reflect the term as provided by the investigator. Reviews the codes for ICH compliance and adherence to coding guidelines and conventions.
• Ensures all safety reports are reconciled in the clinical database. Performs all duties according to company policy and regulations and guidance. Performs other duties assigned by the Director or Sr. Manager. No travel required.
Qualifications
Qualifications:
Graduate of adequate health care related course with commensurate experience in use of dictionaries in Clinical trial setting and have performed clinical data review.
Minimum of 5 years coding experience required as well as AE/SAE data review.
Strong knowledge of ICH guideline, or adequate background and have attended seminars for MEdDRA and WHODD use
Knowledge of Central coding, Ds Navigator , INFORM a plus - Proficiency on all related regulations, GCP, and Good Clinical DM Practice
Computer proficiency and knowledge of medical terminology - Expertise on use of Excel - Strong oral and written communication skills
Additional Information
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
Connect with us on - LinkedIn | Facebook | Twitter
Product Safety Data Coordinator
Woodcliff Lake, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description:
• Data entry into the Product Safety database for Adverse Events reported in association with Client s Marketed and investigational products.
• The activities include, but are not limited to, data entry, coding into standard dictionaries and writing of narratives based on information provided both on standard forms and from medical records and other documents.
• The individual will be responsible for verifying the accuracy and completeness of information for each adverse event report for which he/she is responsible in conjunction with the source documents and ensuring that the activities are performed in a manner consistent with Client s SOPs.
• Following successful training, the candidate will be expected to work from home with the requirement to come into the Woodcliff Lake office on Wednesdays each week.
Qualifications
• Health Care Professional (with or without previous drug safety experience) or non- health Care Professional with previous drug safety experience desired Medical terminology understanding required, with proficiency with MedDRA or doing into other standard medical coding dictionary preferred 2-3 year s minimum experience in medical coding/terminology/data entry within a pharmaceutical organization.
• Computer proficiency required, including data entry into standardized electronic databases STRONG WRITTEN AND VERBAL COMMUNICATIONS ARE ESSENTIAL Experience with data entry into drug safety databases such as ARISg/ARGUS, preferred.
• Strong attention to detail and accuracy Strong proofreading, editing and reviewing skills are essential Must be able to work independently, and possess problem solving skills, but also know when to seek assistance from manager.
• At Client there are two groups in this department. The one group takes the reports and enters the data into the system. They consider that more of a coordinator position only. This role is more involved because it requires analysis of the narrative on the reports
Additional Information
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
Connect with us on - LinkedIn | Facebook | Twitter
Research Laboratory Manager
East Hanover, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Include tracking of activities provided by external contract laboratoreis both clinical and pre clinical. Ensures all necessary documentation is inmplace (ie statements of work/assay development requirements etc). Additional responsibilities include reviewing/distributing all external research reports.
Additional Information
Regards,
Anuj Mehta
************
Business Data Analyst + E-trading
New York, NY job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Business Data Analyst
Charlotte NC/ New York
6 months contract with possible extension
Description:
This project is with the client's Capital Markets Data Services (DS) group and Data Services is looking for an experienced business & data analyst to support the electronic trading business and technology teams. This role will provide the key link between the ET client area and Data Services by planning and conducting analysis for business problems to be solved with automated systems. Success in this role will be measured by the degree to which the candidate can understand the specific data needs of electronic trading and facilitate addressing those needs within the centralized, shared Data Services platform. The ideal candidate has a deep knowledge of electronic trading and the reference data that enables it.
Responsibilities include:
Analyze and document current state processes, data flows, and systems interactions.
Coordinate and manage all activities related to requirements gathering, including coordinating meetings between SME's, documenting requirements, reviewing requirements, and gathering signoffs.
Front-run data requests to understand in advance what data is going to be needed for trading new asset classes and working to produce requirements well in advance of technical designs
Research data vendors/sources and industry practices to obtain data from the best sources (e.g. best way to identify current On-the-Run Treasury)
Take in and document new work requests; manage tracking of all on-going work items; facilitate work prioritization, Coordinate and facilitate the population of test data during system development. Includes sourcing data from external parties (e.g. ECN's IDs for specific securities)
Develop procedures for maintaining reference data, including required tools, roles, and SLA's,
Qualifications:
Capital markets product knowledge is mandatory for below asset classes Clearable & Exchange traded interest rate and credit derivatives Fixed income (Corporate bonds, MBS, Municipal bonds etc.) Equities Electronic Trading reference data knowledge/experience is mandatory, including Exchange and ECN specific data (e.g. Min Tick, Min Increment)
5+ years of relevant business and data analysis experience, working with business, operations, and technology teams
7+ Years of Financial Services experience in capital markets.
Experience in security master/product master domain within capital markets a plus
Preferred Skills:
Ability to query data via SQL and experience with technical systems (e.g. working with XML data files, analyzing data dumps from vendors, accessing data via API's)
Capital markets product knowledge for the specie asset classes: Stocks ETFs Convertible Bonds Listed Options Futures Preferred Treasury Interest Rate Swaps Credit Agency Municipals FX
Qualifications
E-trading/ ELECTRONIC COMMUNICATIONS NETWORK (ECN ) experience is must
W2 candidate for New York/ Charlotte location
Additional Information
For more information, Please contact
Jyoti Pandey
************
Regulatory Manager
East Hanover, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
Provides input into global regulatory strategy, including identification of gaps or risks in global strategic plan for assigned regions.
Partners with regions to align on regulatory strategy in order to fulfill business objectives
Represents DRA on or leads sub-teams as required.
Determines requirements and sets objectives for Health Authority (HA) interactions with regulatory lead
Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
Develops and implements plans for timely response to HA requests and coordinates responses.
Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
Review of global dossier summary documents.
Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
Responsible for finalization and on time submission of annual reports and renewals across assigned regions.
Responsible for appropriate entering and quality of product specific attributes in compliance database.
Ensures regulatory compliance for project and keeps records of all major HA interactions in the validated document management system.
Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes.
Skills:
Prior 2-4 years of regulatory experience required, ideally in US or EU
Strong knowledge of regulatory submission and approval processes, ideally in US or EU
Strong interpersonal, communication, negotiation and problem solving skills.
Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.
Proven ability to analyze and interpret efficacy and safety data.
Regulatory operational expertise
Qualifications
Science based BS or MS with requisite experience and demonstrated capability.
Additional Information
Richha Saini
Senior Clinical/Scientific Recruiter
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
Connect with us on - LinkedIn | Facebook | Twitter
Production Support Technician
East Hanover, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
• Ensure accurate SAP inventories are maintained for all components.
• Proper status segregation and storage of media lots.
• Support the maintenance of an “audit ready” state of the ISO 8 Area
• Timely response to all module requests.
• Batch Records are properly kitted and staged based on production schedule.
• All gowning materials in the ISO 8 area are maintained to adequate levels.
• ISO 8 area has ample supply of non-inventory items
• Logbooks entries are clear and complete.
• Kanban system is utilized to ensure FIFO
• Equipment cleaning is performed as required
• Ensure Batch records are reviewed and corrected in a timely manner.
Qualifications
Skills:
• 1-3years of related experience in cGMP/FDA regulated industry. Warehouse experience preferred.
• SAP knowledge preferred
Qualifications:
• Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required.
• Must be well organized, flexible and work with minimal supervision.
• Ability to lift up to 50 lbs.
• Alternate shifts, weekends and overtime will be required
• Requires handling of chemicals such as corrosives, solvents & bio-hazardous
Education:
• High School Degree or GED equivalent.
Additional Information
For more information, Please contact:
Sneha
************
CLINICAL STUDY DIRECTOR
Jersey City, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
This role is key for medical supervision and medical management of clinical trials proposed or to be performed by the Clinical Science & Operations Platform (CSO) of Sanofi R&D. The Clinical Study Director (CSD) is the medical reference in the clinical study and other clinical activities (clinical part of CTD for registration, feasibility) performed by the CSO. The CSD will provide appropriate medical input and support for all these clinical activities. He/she will provide medical training and medical information to study team(s), Clinical Study Units (CSUs) and investigators. He/she will be deeply involved in the feasibility process. He/she will be accountable for medical review and will collaborate and interact with Pharmacovigilance to review safety data. He/she will interact with Medical Advisors in CRUs or Disease Units), a specialization in a medical area would be requested or at least appreciated.
SCOPE:
All clinical studies related to projects in clinical development (excluding Clinical & Exploratory Pharmacology studies) and medical investigations (e.g. Registry, survey) for projects in development or for marketed drugs.
KEY INDIVIDUAL ACCOUNTABILITIES:
• Medical reference and medical expertise for operational strategy within the CSO for study registries he/she is allocated to
• Medical consultant for projects to be proposed to the CSO
• Medical contact for interaction with physicians responsible for the project or the study at the customer level.
• Support with his/her medical knowledge and background a study or a project from
• business negotiation with customers to final product delivery (e.g. study completion or
• project report or publication)
• Conduct the feasibility for study/project with the feasibility manager and other team members (especially Medical Advisors in CSUs)
• Prepare and/or organize and/or participate to Investigator's Meetings, Steering Committees, Data Monitoring Committee meetings (only "open” part of the DMC meetings).
• Prepare and/or approve any documents related to the study and requiring a medical expertise (extended synopsis, protocol, medical training material for study monitoring team and for investigators)
• Provide medical training to study team, CSUs (Medical Advisors, monitoring) and investigators
• Develop interaction with Medical Advisors in CSUs for the best knowledge of the study, compound protocol.
• Participate to Investigators meetings
• Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts
• Participate to clinical trial team (and cluster if any) meetings
• Accountable for the medical review of data done by the clinical trial team, the case by case review of safety events reported to GPE and coding of events and drugs
• Provide appropriate medical input for patient recruitment and retention strategy
• Support the CSUs and affiliates to develop network of KOLs and experts and to select National Coordinators or members of Study Committees
• Prepare and provide key medical information to investigators and/experts in respect with communication policies (e.g. study results, DMC advice)
KEY SHARED ACCOUNTABILITIES:
• Feasibility results with feasibility managers
• Project/Study deliverables with the Clinical Study Team
• Operational strategy with Project Leader (s)
• Get support from the Unit Management Office to get appropriate medical staff in CSUs and to determine appropriate study budget according to medical considerations
• Collaborate to Adjudication Committee Review including prior patients' data review as needed
• Ensure high quality execution from a medical perspective with support of all functions &
• Quality & Continuous Improvement group
• Ensure appropriate documentation and investigations of safety cases with Global
• Pharmacovigilance and Epidemiology (GPE).
• Ensure high quality of coding with coding officers
Qualifications
Basic Qualifications:
• Licensed United States Medical Doctor or an International medical graduate who has certification by the Educational Commission for Foreign Medical Graduates (ECFMG).
• 2-3 or more years of Phase 2/3 Clinical Research / Drug Development experience in the pharmaceutical industry.
Preferred Qualifications:
• Knowledge in ICH, GCP and local regulations
• Fluent in English (writing and speaking)
• Additional Clinical Research and/or Drug Development experience in other therapeutic areas, especially Cardiovascular and Metabolism.
Additional Information
For more information, Please contact
RAKSHAK SINGHAL
************
Scientist II (PK/PD)
East Hanover, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Cross project Clinical Pharmacology support for late stage clinical programs.
Contribute to the design and coordination of pharmacokinetic / DMPK related elements for clinical projects. Identify potential project hurdles, suggest solutions and establish contingency plans. Represent Oncology Clinical Pharmacology (OCP) on clinical trial teams to support early or late stage clinical programs.
Contribute expert input into key pre-clinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND / IMPD's and NDA's within agreed timelines, and meeting all regulatory requirements under frequent guidance from manager.
Facilitate constructive collaboration within drug development teams (GPTs, etc) and with other internal partners (e.g. DMPK, Toxicology, Formulations, Drug Regulatory Affairs, Clinical Development).
Work with a senior colleague or supervisor to define and update as appropriate the PK, PK/PD, DMPK, biopharmaceutical and pharmacometric requirements in the OCP and/or pre-clinical project development plans.
Monitor timelines, objectives and, as appropriate, budgets. Ensure accuracy of project and activity progress in company tracking tools (e.g., Succeed, ModTracker). Assure rapid and effective communication of high quality data and results to project teams with support of manager.
Follow internal processes, adhere to Client and project specific standards and, when required, adhere to Health Authority requirements (SOPs, Master Analysis Plan, GCP, and regulatory guidelines). Contribute to writing and updating new processes and standards for OCP.
Contribute to and participates in OCP or project sub-teams. Coordinates with appropriate subteam members and/or prepare summary documentation.
Maintain and enhance technical and drug development expertise (e.g. training courses, external meeting attendance). Help conduct training / study sessions within OCP and for other line functions.
Contribute to meetings with external parties including investigators and outside experts.
Languages:
Fluent English (oral and written)
Experience/Professional requirement:
1. 0-10 years of relevant academic, industry, or government experience
2. Proficiency with pharmacometric tools (e.g., WinNonlin, SAS, NONMEM, Trial Simulator, GastroPlus, SymCyp).
3. Knowledge of related disciplines (e.g., DMPK, biostatistics, toxicology, regulatory) in the drug development process.
4. Ability to work as part of a cross functional team in a highly dynamic, matrixed, project-team environment.
5. Strong oral and written communication skills.
6. Strong organizational and project skills.
7. Critical thinking and problem solving skills.
Qualifications
Education:.
Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral training, or equivalent experience.
Additional Information
Best Regards,
Akriti Gupta
**************
Morristown, NJ 07960
Project Manager-III - (Medical Communications)
East Hanover, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description:
Provide global implementation and communications support for the Global Oncology MSL Excellence Program, including MSL functional training, internal communications, MSL digital tools and projects. Support the Global Medical Information team on medical information digital tools and training.
•Support the Global MSL Director by developing internal communication plans regarding implementation and execution of the Global MSL Excellence Program, including written communications for internal websites, newsletters and e-mail announcements.
•Manage communications and training supporting awareness and implementation of MSL digital tools including pipeline app across users, administrators and leadership.
•Support the development of meeting agendas, minutes and all aspects of project management for MSL Leadership meetings, MSL training webcasts and select Global MSL Excellence projects.
•Update and maintain Global MSL Sharepoint site and internal MSL website to serve as resource and communication platform for MSLs and MSL Managers worldwide.
•Assist MSL Insights Team leads to monitor insights and develop action plans.
•Manage congress medical booth process to identify booth staff, coordinate communications, logistics (iPads) and track budget for the MSL staff at key international congresses.
•Ensure maintenance of master contact lists for global insight teams, MSL workstream members and digital leads / administrators.
•Track deployment activities for the scientific engagement approach and certification of MSLs.
Skills:
•Excellent written and oral communication skills
•Strong experience writing internal medical communications
•Prior experience training MSL teams
•Must have direct experience as a field MSL or in a role supporting field MSL team
•Excellent organizational skills and ability to manage complex projects
•Strong working knowledge of excel, word and powerpoint
•Experience working cross-functionally and across countries/regions preferred
•Oncology therapeutic knowledge preferred
Education:
•Doctoral degree preferred (M.D., Ph.D., or PharmD), 5+ years postdoctoral experience preferred.
Qualifications
Education:
•Doctoral degree preferred (M.D., Ph.D., or PharmD), 5+ years postdoctoral experience preferred.
Additional Information
For more information, please contact
Sneha Shrivastava
************
Clinical Program Manager
Madison, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
The Clinical Program Manager will work cross functionally to develop, track and maintain timelines, resource needs and Key Performance Indicators/Key Quality Indicators across clinical development, coordinate clinical program reviews, prepare tracking summary reports/dashboards for leadership and support the team in ensuring adherence to clinical program plan. Job Responsibilities: Enter and maintain resources estimates into PCH product portfolio/resource system Support the development of a standard clinical development timelines, internal KPIs/KQI and collaborate with Clinical development teams to align on these KPI/KQI Maintain and ensure accuracy and alignment of the different reporting tools pertaining to clinical development activities within the organization (timelines, resources, KPIs/KQIs) and develop a best practice process document to improve efficiency and decrease manual intervention. Provides monthly tracking project/KPI/resource reports Coordinate project reviews (sets agenda, prepares content, develop minutes, action plans and ensures follow up) Drive standardization of reporting for clinical development across the various medical franchise Manages PO for contractors Support teams in managing broad process improvement/innovation initiatives within clinical development
Qualifications
Requirements: Bachelor s Degree. A minimum of 4 years of experience in clinical development or related pharmaceuticals fields is preferred. Project Management Certification preferred, or minimally 3-5 years project experience including budget management experience. Strong planning, tracking, and follow-up skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management. Candidate must have strong knowledge and experience with MS project, planisware, or similar project management systems and excel. Candidate must possess strong communication skills, both oral and written, and the ability to collaborate and align with diverse, cross-functional teams. The candidate needs to have clinical experience, know how to create process maps and master excel. Project Management expertise and PM certification or direct PM training, most candidates to date are over-priced. please submit additional candidates -> Mid-Level Position 6 month position with possibility to be extended to 1 year, Strong planning, tracking, and follow-up skills - Proficient in Excel (including ability to understand programming)
Please note: The manager is not looking for a study manager or a CRA/CTA.
The candidate will not be working on the operational aspect of our clinical studies but will help project manage our clinical portfolio (across clinical programs/studies from pre-IND to NDA submission)
Additional Information
Neha Sharma
Lead Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
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Deskside support
New York, NY job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Hope you are doing well !!!
Here are the details !!
Deskside support
Location:New york,NY
Duration 1 year
Skills Overview (list or overview) 3 Years client facing deskside support in a Windows 7 environment performing Incident.
IMAC and Remote take over support.
Mac support would be preferred but not required.
Trade floor experience
Request you to confirm me about trade floor experience .
Additional Information
For more information, Please contact
Shubham
************
Senior Zoning & Permitting Specialist
Paramus, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Prepares candidate information reports related to leasing and land use viability. Prepares lease or other real estate agreements. Coordinates with or supervises outside vendor partners, environmental engineers, architectural & engineering firms, engineers and drafting technicians, title search firms and others to ensure transactions close within defined timeframes. Identify potential risk scenarios. Draft and proof recordable transaction documents, easements, warranty deeds, etc. for legal department review. Prepare zoning and permitting applications. Monitor progress of the application and facilitate jurisdictional requests for additional information as a result of the application review process. Ensure compliance to the quality and safety goals and objectives.
Serves as Senior Site Acquisition Specialist or Lead for particular site project including leasing and land use processing. • Receives updates from Site Acquisition Specialists and Associates and reports information to Site Acquisition Manager • Provides weekly status reports to Clients and serves as project lead during weekly client meetings • Assists Site Acquisition Manager with training of Site Acquisition Specialists and Associates • For new-build projects, commonly responsible for site acquisition activities from initial search ring release through building permit issuance. • For existing site modification projects, commonly responsible for site acquisition activities from leasing and zoning audit through building permit issuance. • Provides candidate-specific recommendations for leasing and land use viability. • Supervises the administration, planning, operations, and work of consultants and subcontractors. • Communicates activities with team members and other departments, as needed. • Provides site sketches, as needed. • Attends field site visits for candidate and engineering viability • Reviews title reports for ownership, encumbrances, easements, etc, and provides recommendation for leasing viability. • Interviews zoning/permitting personnel to obtain jurisdictional approval requirements for installation of wireless communication facilities and/or related • wireless equipment as project scope defines. • Completes Leasing Audit & Zoning Ordinance Reviews for site modification projects. • Reviews zoning drawings prior to submittal for compliance with public agencies and client requirements • Prepares, submits and obtains land use entitlement applications which may include presentations before governmental or architectural review boards. • Coordinate with client and engineering department to obtain information necessary for entitlement applications (RF Affidavits, propagation maps, photo-simulations, etc…). • Reviews and approves site specific documents • Reviews the quality and completeness of site specific documentation • Tracks progress on all open transactions • Completes collocation applications and associated documents. • Maintains a high degree of customer service and integrity when dealing with clients • Other duties or special projects, as assigned. • Verifies and/or obtain Enhanced 911 addressing. • Acts in capacity of a “lead person”. Does not have management responsibility for the people to whom they provide work direction. List supervised positions: Site Acquisition Administrator (Level 1-3)
Qualifications
Education: Requires 4 year degree, or equivalent work experience. Experience: Requires 5 years telecommunications industry experience.
All applicants must be able to complete pre-employment onboarding requirements (if selected) which may include any/all of the following: criminal/civil background check, drug screen, and motor vehicle records search, in compliance with any applicable laws and regulations.
Prefer knowledge of tower industry. Prefer supervisory experience. Paralegal certificate preferred. Preferred Competencies: • Ability to work independently as well as with others • Excellent oral and written communications skills • Real estate, sales, or legal negotiation experience strongly desired • Ability to communicate and negotiate effectively • Ability to read and comprehend legal documents such as legal descriptions, surveys, ground leases, easements, deeds, land purchase contracts, mortgages, title policies, subordination, and CAD drawings • Advanced proficiency in Microsoft Excel, Word, and Outlook • Adheres to, supports and enhances the Divisions Environmental, Safety, Health and Security Program and enhances the Divisions Quality Management System.
Additional Information
For more information, Please contact
Gayathri
************
Brand Safety Leader
East Hanover, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Development of processes and identify and qualify new business opportunities. This role links closely with R&D to leverage technical possibilities and understand technical trade-offs vis a vis market potential. Works closely with market research group to discover new consumer/ patient insights. As initiatives advance toward market launch, this role will also support the development of the winning consumer & ECP big idea, and lead concept, claims, key benefit and RTB visuals, as well as any relevant sights & sounds cues. It is crucial the candidate has global experience as well as innovation, new product development, and/or new product launch experience. This individual must be proficient in market landscape assessment, analyzing diverse market segments and providing recommendations on new market opportunities. This position also supports BD&L in the scouting and due diligence processes with market assessment, concepting and financial calculations.
1. Responsible for safety issue management from end of Phase I (POC) through Life Cycle Management.
2. Accountable for overal signal detection, monitoring, evaluation, interprettion and appropriate management of safety information, based on information from all relevant line functions, postmarketing data, and other sources.
3. Accountable for developing and updating, at mlestones, the safety profilling and risk management plan from end of Phase I (POC) through Life Cycle Management, as relevant. Accountable to ensure adequate risk management plans are in place.
4. Leads Safety Management Team.
5. Serves as safety representative as core member of Global Program Teams. Manages Drug Safety Monitoring Board activities for assigned projects/products, as required.
6. Accountable for responses to inquiries from regulatory authoriries or health care professionals on safety issues. Accountable for safety data for health authority review boards. Accountable for responses to legal queries and CPO requests involving safety issues. Ensures safety information communicated to EU Qualified Person in a timely fashion. Coordinates product-specific activities.
7. Accountable for integrated safety input into all safety relevant parts of regulatory and company documents (i.e. IB, CDS, SCS, RMP, SPP, CO, PIP, GDPS, CDP, etc.) required during active development, submission phase and during marketing phase.
8. Review of medical safety input into study protocols (including MRC and OPCE) MAP, RAP and ICF.
9. Review/approve product-specific safety deliverables: IN letter, PGD, data searches, literature review, expert statements.
10. Coordinates involvement of external experts (e.g. authors of "white papers," members of trial-specific data safety monitoring boards, ad-hoc support for HA meetings, etc.
11. Accountable for presentations on project/product safety issues to internal clients's Boards, or expert panels and other meetings.
12. Collaborates productively and manages in a cross-functional matrix team environment (e.g., SMT).
13. Assist in training of new hires (e.g. new BSLs) and mentor/coach direct reports (PVL/PVE) as required.
14. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
15. Serves as and performs activities of Pharmacoviglinace Leader such as ad-hoc medical case review as needed.
Qualifications
Education:
MD
Additional Information
Manpreet Singh
************
Clinical Research Scientist (EZIJP00002334)
Woodcliff Lake, NJ job
Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications.
At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources.
Job Description
The incumbent is responsible for, but not limited to the following:
• Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
• Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, Client, Investigator Brochure, etc)
• Performs literature search and data analysis to address research questions
• In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
• Assisting in database cleaning, review of study results, and interpretation of results
• Adhering to key performance indicators for clinical study development, conduct, and reporting
• Individual contributor with specialized knowledge
• Presents concepts, facts, and reports and advises on key trends and issues
• Troubleshooting routine site inquiries
• Work is completed under limited supervision
• Supports the planning, execution and reporting of clinical programs/trials
• May handle multiple protocols simultaneously
• Contributes to risk resolution by escalating and monitoring project risks
• Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry
• A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements
• Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred
• Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area;
• Bachelor's Required. Doctoral (PharmD or PhD) degree preferred
Qualifications
BS/MS
Additional Information
For more information, Please contact
Best Regards,
Akriti Gupta
**************
Morristown, NJ 07960
DESKTOP SUPPORT
New York, NY job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Desktop support
Purchase ,NY
DURATION 3 DAYS
Desktop support skills
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Candidates should be able to diagnose and remedy complex Microsoft OS problem tickets, configure and install common applications and install/remove desktop PCs and monitors.
·
Remote take-over skills a plus. Must have good verbal and written skills, as well as ability to interact positively with clients.
Additional Information
For more information, Please contact
Shubham
************
Clinical Research Associate (CRA)
Woodcliff Lake, NJ job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
• Assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments.
• Participate in development of protocol, case report form, CRF guidelines and other study documents.
• Prepare and/or review regulatory documents (e.g. ICF), contracts, requests for proposal.
• Ensure the training of CROs/investigators on protocol, regulatory, Client SOPs and data issues.
• Reviews and approves monitoring reports and ensures tracking of ongoing site issues.
• Minimum of college degree in a relevant discipline.
Qualifications
• Bachelors degree in relevant scientific discipline preferred.
• 1-2 years experience in pharmaceutical industry.
Additional Information
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
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