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Job Search Results: Jobs 1 - 10 of 24  View Titles Only  Page 1 of 3
 
Title   Company Name     Location   Date  
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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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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Associate Director, Quality Control 

  Makro Technologies    All   28/11/2006 
Category: QA - Quality Control, Clinical Research, quality control  
Education:   Position type: Full Time  Experience: 5 years 
Area(s) of expertise desired: Biochemistry, GLP, GMP, Information Systems, Quality Assurance, Quality Control, Regulatory Affairs  
Description:
Full Requirement : As an Associate Director for QC, you will be responsible for managing and assuring the continued compliance with GMPs for the QC laboratory operations, as well as the development, implementation and maintenance of Quality Control testing, and the systems and activities within the Quality Control areas for analytical testing, lab support, cell biology and method development. You will oversee the development and implementation of standards, methods, and procedures both for inspecting, testing and evaluating the precision, accuracy and reliability of the company's products and for supporting GMP compliance within the company's manufacturing facilities. You will also oversee laboratory operations including investigations, deviations, validations and troubleshooting, as well as review SOPs, reports and submissions. Additional responsibilities will include participating in regulatory discussions, strategies for CBER submissions, providing information and reviews for technical content, and leading discussions and interactions with inspectors and regulatory contacts. You will be responsible for the training, performance and career development of Quality Control staff, including evaluating staff performance and recommending merit increases, promotions, and probations to Human Resources and to the Director, QC. You will also oversee the administration of company personnel, health and safety, and hazardous materials policies, as well as prepare and manage the budget for the department.  
Requirements:
Qualifications 6-10 years experience in a regulated biologics cGMP manufacturing industry.Technical protein chemistry experience, QC lab method development, validation, raw material program management, utility testing and monitoring, including wet chemistry, biochemistry and biological assays. Experience with FDA inspections, regulatory authorities, regulatory submissions. Experience in a cGMP Compliance oriented environment. Working knowledge of FDA, cGMP, EP/JP and ICH guidelines. Strong oral and written communication skills. Computer skills with MS office and familiarity with SAP and LIMS database beneficial.BS, MS in Science and experience in the regulated industry  
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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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Senior Clinical Research Associate 

  Hays Pharma    All   10/7/2007 
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, life sciences  
Education: Bachelors   Position type: Full Time Employee  Experience: 3 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research, Research  
Description:
Senior Clinical Research Associate


PURPOSE OF THE JOB

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, SOPs/WPs, applicable regulations and the principles of ICH-GCP
Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of systems and procedures as appropriate.
Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
Provide a benchmark for acting according to company values and act as a positive promoter


 
Requirements:
JOB FUNCTIONS/RESPONSIBILITIES

Knowledgeable of Clinical Research SOPs/WPs, ICH-GCP and appropriate regulations.
Knowledgeable of clinical systems
Recruitment of investigators.
Independent and proactive co-ordination of 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.
- Co-ordinate documents translation, verification and back translations where required.
- Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements.
- 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 regularly 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.
- Maintain patient and sponsor confidentiality.
- Assume additional responsibilities as directed by Associate Clinical Project Manager/Clinical Project Manager (CPM).
- Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by a CPM/Associate Clinical Project Manager.
- Co-ordinate and/or participate in feasibility studies for new proposals, as required.
Be cost effective.
Participate in mentoring and training new staff.
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 (international and domestic fly and drive)
Ability to review and evaluate clinical data arising from aptitude and have the required level of experience in Clinical Research.
Computer literacy required.
Foreign language skills desirable.
Current full driving licence essential.
Good oral and written communication skills.





 
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Clinical Research Associate II 

  Hays Pharma    All   10/7/2007 
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  Experience: 2 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research, Regulatory Affairs  
Description:
My client, a global leading organisation within the pharmaceutical industry, is presently seeking a Senior CRA to work over in Berkshire.

My client is looking for candidates to perform trial initiation, monitoring and close out activities in Phase II-IV clinical research, managing study site activities to ensure clinical data integrity in line with company and regulatory guidelines, and providing clinical and technical support to other CRAs and administrative staff.

As Senior CRA you will provide clinical and technical support, conduct co-monitoring/training visits and assist with protocol review, CRF and informed consent development, plus study start up activities. Where required, you will be the primary client contact for project related activities, and also act as mentor for CRAs.

 
Requirements:
Reporting to project leader, you may assume the role of a Lead CRA on projects by providing direction to the project team, coordinating monitoring activities, developing CRFs and acting as liaison between monitoring and other functions.  
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VP/ Director RA / QA 

  Mengo    All   8/5/2009 
Category: QA - Quality Control, Biotechnology, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs  
Education:   Position type: Full Time Executive  Experience:  
Area(s) of expertise desired: Medical Device, Pharmacology, Quality Assurance, Regulatory Affairs  
Description:
Responsibilities:

1. To establish, maintain and improve the quality system in accordance with 21CFR820, ISO9001 and ISO13485
2. To act as the management representative as defined in the quality system responsible for:
ensuring that quality system requirements are effectively established and maintained; and
reporting the performance of the quality system to senior management for review

3. To manage the following quality system processes to ensure compliance with the applicable regulations, standards and directives including:
Documentation control, auditing, training, management review, complaints, product quality acceptance, supplier control, change control and quality planning.

4. Assist with the preparation, filing, and negotiation of submissions to regulatory bodies to obtain market or clinical research approvals including ongoing trials and post-approval activities.
5. Review clinical trial documents including clinical protocols/reports, investigator brochures, nonclinical reports, CMC protocols/test methods;
6. Reviews labeling, promotional material, product changes and documentation for changes requiring government approval
7. Monitor changes to domestic and international regulations and standards and ensure compliance with those regulations and standards
 
Requirements:
Qualifications:

** More than 10 years experience in the Biopharmaceutical or Medical Device industries.
**At least 5 years management experience in Quality assurance and Regulation in Biopharmaceutical or Medical Device industries.
** Experience with Notified Bodies in Europe.
** Experience with quality requirements for clean rooms and sterilization

 
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Clinical Project Manager 

  Hays Pharma    All   10/7/2007 
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  
Education: Bachelors   Position type: Full Time  Experience: 4 years 
Area(s) of expertise desired: Clinical Research  
Description:
Managing all aspects of studies or study programmes allocated by the GM or SPM and to be responsible for ensuring control of allocated study budget.

 
Requirements:
Responsibilities include:

To participate in the preparation of clinical development plans
To manage clinical studies
To ensure that studies are performed and completed in accordance with the pre-defined budget, timelines and quality specifications
To participate in CRO evaluation and selection and be responsible for making selection recommendations to SPM/DGM
To coordinate the establishment of service provider contracts.
To ensure that a safety reporting system is in place and that safety reports are provided to the Safety Department in a time manner
To ensure that studies are conducted in accordance with EU GCP requirements and relevant company SOPs
To produce or co-ordinate the preparation of study protocols  
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CRA II 

  Hays Pharma    All   13/7/2007 
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 Data Management, Clinical Research  
Description:
Our client, a worldwide Contract Research Organization, is seeking for its branch in Milan a Senior CRA to Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, SOPs/WPs, applicable regulations and the principles of ICH-GCP. Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of the Company"s systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues and acting according to Company"s values and as a positive promoter.

 
Requirements:
For this role is required significant experience as a CRA for at least 18 months.

This is for an international company- please provide all CV's in English format
Thankyou  
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Manufacturing 

  Fellen Project    All   2/8/2007 
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: Masters   Position type: Full Time Employee  Experience: 2 years 
Area(s) of expertise desired: Manufacturing/Production  
Description:
Our client, a manufacturing company. has an immediate opening for cost accountant with 4-year accounting degree and a minimum of 2-4 years experience in a manufacturing process cost environment. Responsibilities include preparation of manufacturing budgets, month-end close, standard cost and variance analysis, financial analysis, and inventory reconciliation. The successful candidate should have the ability to work with various levels of management and a working knowledge of Microsoft Excel. JD Edwards or other MRP package experience preferred. Salary 45-55K. DOE  
Requirements:
Our client, a manufacturing company. has an immediate opening for cost accountant with 4-year accounting degree and a minimum of 2-4 years experience in a manufacturing process cost environment. Responsibilities include preparation of manufacturing budgets, month-end close, standard cost and variance analysis, financial analysis, and inventory reconciliation. The successful candidate should have the ability to work with various levels of management and a working knowledge of Microsoft Excel. JD Edwards or other MRP package experience preferred. Salary 45-55K. DOE  
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