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Job Search Results: Jobs 1 - 10 of 16  View Titles & Details  Page 1 of 2
 
Title   Company Name     Location   Date  
Computerized systems validation engineer 

  Comply    All   1/4/2015 
Category: QA - Quality Control, IT/Hardware/Software  
Education: Bachelors   Position type: Full Time  Experience: No experiece 
Area(s) of expertise desired: Business Analyst, Compliance, GLP, GMP, Information Systems, Medical Device, Other, Professional Services, Validation  
Description:
Write Computerized systems validation documents and test protocols: STP,STD,IQ,OQ,PQ
Write Computerized systems design and summary documents: URS,FRS,VP,STR,VSR
Write SOPs ( Standard Operating Procedures) , Work instructions
Write software applications reject lists, bug identification, report and monitoring.
Functional testing of life-science computerized systems.
 
Requirements:
Minimum Qualifications

Education: BA/BSC in Biotechnology, Chemical Engineering, Biomedical engineering, Chemistry, Biology, Computer Science
Communication: Excellent oral and exceptional technical writing skills with the ability to interface effectively and professionally at all levels.
Organized person with high ability to work with fine details.
Excellent English( Equal to mother tongue).
QA oriented : Experience with QA in the life-science industry( Pharma ,Biotech and Medical devices). Optional- Experience with QC in the life science industry.
Service oriented.

Preferred Qualifications

Experience with use of life science computerized system ( e.g. LIMS, ERP systems, computerized Lab systems ( Empower, FTIR etc..), production systems etc.)
Experience with IT subjects (i.e. Server- Client topology, Data backups, Help Desk etc.)
Experience in software testing\ computerized system validation in the life science industry
Knowledge in roles and guidelines: 21CFRPart11, GAMP5 ISO 14971:2007,IEC 62304
 
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manager 

  larry bee    All, chicago   15/3/2012 
Category: QA - Quality Control, IT/Hardware/Software  
Education: Masters   Position type: Full Time Manager  Experience: 6 years 
Area(s) of expertise desired: Academic  
Description:
A management consulting firm, we are focused exclusively on the metals industry. Our objectives are to identify opportunities for clients to reduce the cost of new metal, improve the value received for scrap, manage price risk exposure and strengthen administrative and financial controls.  
Requirements:
A management consulting firm, we are focused exclusively on the metals industry. Our objectives are to identify opportunities for clients to reduce the cost of new metal, improve the value received for scrap, manage price risk exposure and strengthen administrative and financial controls.  
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software engineer C++ 

  Mengo    Tel Aviv Area   16/7/2009 
Category: Engineering, Medical Equipment, IT/Hardware/Software  
Education: Bachelors   Position type: Full Time Employee  Experience: 5 years 
Area(s) of expertise desired: Academic, Other, Software Development, , software  
Description:
 
Requirements:
 
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Software / Image processing engineer 

  Confidential    Tel Aviv Area   8/6/2009 
Category: Medical Equipment, IT/Hardware/Software  
Education: Bachelors   Position type: Full Time  Experience: 3 years 
Area(s) of expertise desired: Software Development, Image processing  
Description:
Medical Imaging product development experience in image processing.
Design and develop concepts for new algorithms. Design and implemention of GUI. Debugging and system integration. Interact with customers  
Requirements:
3+ years experienced with C/C++.
Strong understanding of Object Oriented Design (OOD) and Programming (OOP).
Extensive knowledge experience in one of the following: Image Processing/Image recognition processing - preferred.
Oral and written communication skills in English Must.
Strong problem solving and troubleshooting skills.
Ability to work in a team, ability to work independently.
Commitment to work plans and schedules.
Creativity, Self learner, Quick learner.

Education
Masters/Bachelor degree in engineering (Computer, Electronics).  
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Sales 

  skidoventures    All, Kuala Lumpur   17/1/2009 
Category: IT/Hardware/Software  
Education: Bachelors   Position type: Full Time Employee  Experience: 2 years 
Area(s) of expertise desired: General Services  
Description:
Responsible for assessing, planning, implementing and evaluating physical, psychological, emotional, spiritual, cultural and social needs of the resident

Validates the plan of care, goals and objectives with the resident/family  
Requirements:
Bachelor of Science Nursing or equivalent

Proven organizational, observational, interpersonal and communication skills  
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CRA 

  Hays Pharma    Tel Aviv Area   4/11/2008 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing, IT/Hardware/Software  
Education:   Position type: Full Time  Experience:  
Area(s) of expertise desired:  
Description:
Our client, a global CRO is looking for Clinical Research Associates with minimum 1 year of experience join a professional team.

The responsibility of a Clinical Research Associate II (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with companys SOPs. As Regional CRA or Primary CRA (on smaller studies) responsibilities will include managing clinical monitoring activities in addition to the ownership of investigator sites, including investigator/site selection, collating regulatory documentation, initiation and monitoring (source data verification, drug accountability and data collection) in accordance with ICH GCP guidelines.

Responsibilities

Perform clinical trial initiation, monitoring and closeout activities.
Assists with study start-up activities, site selection, and pre-study activities to identify and evaluate potential investigators.
Assists in site evaluation and reports to Lead CRA / Project Leader as appropriate.
Assists in submission of documents to the Ethics Committees, when required.
Participates in study specific training.
Assists with the preparation and coordination of investigator meetings and attends meeting.
Provide status updates of pre-study and initiation activities to Lead CRA / Project Leader.
Completes initiation visits with study staff through training, reviewing regulatory requirements, collecting outstanding documents, reviewing patient screening/randomization procedures, reviewing SAE reporting requirements, and reviewing drug storage and accountability procedures.
Assists in development of patient enrollment strategies with the project team and study site coordinator
Ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials.
Completes monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification and SAE reporting in accordance with the project plan.
Manages study site activities and provides ongoing updates of site status to Lead CRA / Project Leader.
Maintains tracking records for assigned sites such as tracking of status and source document review per patient.
Completes study site closeout visits.
Assists with Project specific administrative activities as a member of the project team.
Ensures site registration in Investigator Database.
Increases knowledge of drug development process, therapeutic areas, Good Clinical Practices, and any applicable local regulatory requirements.

 
Requirements:


MD
Fluent official language of the country
English, written and spoken, upper intermediate
PC user
 
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Medical Advisor-Greece 

  Hays Pharma    Worldwide   4/11/2008 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing, IT/Hardware/Software  
Education:   Position type: Full Time  Experience:  
Area(s) of expertise desired:  
Description:
Medical Advisor opportunity has arisen within a blue-chip pharmaceutical company in Athens. This is a highly interactive role, demanding effective strategic thinking and planning skills and the ability to network, teamwork and build influential relationships with your colleagues, customers and external opinion formers.
As a Medical Advisor you will provide a specialist role in a number of therapeutic areas. You will work closely with your commercial colleagues to provide pro active input into the strategic management of the business, jointly agreeing, developing and implementing strategic direction within key therapeutic areas, allowing commercial aims and ambitions to be met.

The role requires a good understanding of clinical development processes and of the changing health care environment


Accountabilities

Providing authoritative opinion on medical, legal and regulatory matters to support your colleagues across the UK, enabling them to comply with the relevant statutory requirements (e.g. Code of Practice, Medicines Act, and EU Directives).
Provision of pro active input to the development of business strategy.
Effectively developing relationships with key influencers and external organizations to ensure that the company retains a leading voice in the pharmaceutical industry.

Coordinating and utilizing specialist knowledge with brand aligned colleagues in formulating and implementing short and long term medical strategy for optimal commercial benefit.
Working closely with regulatory, commercial and clinical colleagues on pre-launch planning, including strategic evidence planning and generation.
Influencing clinical research strategies in support of market needs
Provide medical information
Knowledge of the clinical practice, care pathways, key competitors, etc. and input where required into study allocation process.
Input into a development of local protocols, patient information customer-initiated research projects (CIRPs) and named patient programmes.
Input into reviews and sign off of abstracts, reports and publications.
Pro active input into European Medical meetings to ensure strategy is supported.
Review and sign-off Regulatory documents as required.

 
Requirements:
Qualifications/Experiences

A registered medical doctor.
Expert therapy knowledge in a broad range of therapeutic areas,
Continuous record of career achievement through clinical development and/or medical affairs positions.
Previous industry experience would be beneficial
A good understanding of the changing health care environment.

 
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R & D MANAGER 

  BINA HR CENTER    Sharon Area   12/8/2008 
Category: Engineering, Medical Equipment, IT/Hardware/Software  
Education:   Position type: Full Time Executive  Experience: 5 years 
Area(s) of expertise desired:  
Description:
WE NEED A R & D MANAGER  
Requirements:
Bsc in Electrical Engineering

Few years of experience in board design

Few years of experience in managing small projects with many point

of contacts

Few years of experience in working with micro-controllers, specifically ARM processors

Experience in working with sub-contractors, 3rd party companies and external consultants.

Good understanding of algorithmic design and digital design flows

Understanding of software methodologies

Ability to define requirements and derive specifications

Experience with real-time design - an advantage

Experience with bio-signal processing - an advantage
 
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147861 Field Service Engineer - USA 

  CPS    Worldwide   25/3/2008 
Category: Biotechnology, Engineering, Life Sciences, Medical Equipment, IT/Hardware/Software  
Education:   Position type: Full Time Employee  Experience:  
Area(s) of expertise desired:  
Description:
this position is a "roving" position that should be based in new jersey.
the field service engineer [fse] is responsible for the implementation of the company systems at designated medical centers. this role is the primary liaison between the medical center and the company hq for technical and training issues.
primary responsibilities:
responsible for installation, maintenance, troubleshooting and repair of optic-mechanical equipment in the field of medial devices. provide product support, software and hardware, installation, operation & servicing training to customers.
provides weekly status reports, maintains up-to-date database and field service reports.
conducts classroom, on-site and online (remote) training with the customer.
modifies, develops and maintains end-user training materials/guides.
develops and administers customer competency exams - including scoring exams, communicating results, and suggesting remedial action where needed.
facilitates system enhancement requests, system corrections, and customer issues in relevant software.
qualifications:
technical professional with expertise in a healthcare regulated environment. bachelor degree in a technical discipline, with at least 4 years practical work experience in a technical healthcare environment and medical multidisciplinary (mechanics, optics, electronics, software, etc.) devices.
demonstrated success in working with customers (mainly hospitals), vendors, and leading cross-functional teams. interpersonal skills and customer service orientation.
strong process orientation, problem solving & troubleshooting skills, and a firm commitment to quality operating with various computer software.

excellent presentation, communication and conflict management skills.
knowledgeable in the system design, build, testing, training, supporting and go-live activities.
willingness to travel up to 80%, including overnight stays with trips to the company headquarters in israel.
displays professional, team-oriented attitude to co-workers and customers.
ethics and integrity - strong interpersonal with a high degree of self-motivation and ability to work independently away from the headquarters, peers and managers. responsible, independent and accurate.
excellent verbal communication skills.

a calm, helpful demeanor and the ability to handle deadlines and cope with stressful situations.  
Requirements:
 
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Clinical Research Associate/Senior Clinical research associate- office/home based 

  Hays Pharma    All, Izrael (anywhere)   6/11/2007 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing, IT/Hardware/Software  
Education:   Position type: Full Time Employee  Experience: 2 years 
Area(s) of expertise desired: Clinical Research  
Description:
JOB FUNCTIONS/RESPONSIBILITIES:

Recruitment of investigators.
Co-ordinate all the necessary activities required to set up and monitor a study, including the following:
Identify investigators
Help, when requested, in preparation of regulatory submissions
Design patient information sheets and consent forms.
Ensure timely submission of protocol/consent documents for ethics/IRB approval.
Placement and initiation visits.
Conduct regular monitoring visits in accordance with site monitoring SOP / Sponsor site monitoring SOP, as appropriate
Maintain all files and documentation pertaining to studies.
Motivate investigators in order to achieve recruitment targets.
Complete accurate study status reports.
Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
Keep the project manager informed.
Process case record forms to the required quality standards and timelines.
Deal with Sponsor generated queries in a timely manner.
Ensure the satisfactory close-out of investigator sites.
Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
Ensure correct archiving of files on completion of a study.
Co-operate with sponsor and/or QA personnel in the conduct of QA audits.
Maintain patient and sponsor confidentiality.

 
Requirements:
Cost effectiveness.

To participate in training new staff as appropriate.

Assist with marketing the company if and when appropriate.



QUALIFICATIONS/EXPERIENCE REQUIRED:

Medical/science background and relevant experience.

Ability and willingness to travel at least 50% of the time.(lnternational and domestic: fly and drive).

Ability to review and evaluate clinical data.

Computer literacy desirable.

Foreign language skills desirable.

Current full driving licence essential.

Good oral and written communication skills.



 
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