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Job Search Results: Jobs 1 - 10 of 24  View Titles Only  Page 1 of 3
 
Title   Company Name     Location   Date  
Account Executive Scientist 

  Michael Page    Tel Aviv Area   13/8/2013 
Category: QA - Quality Control  
Education:   Position type: Full Time Executive  Experience:  
Area(s) of expertise desired: Medical Device  
Description:
We are looking for an Account Executive Scientist to devolop the Israeli market for an Internaitonal company.
Actively involved, through direct participation in office or field clients visits to understand client’s needs, provide technical scientific or regulatory solutions, provide regulatory or business presentations
Makes client visits, with a special emphasis on scientific and regulatory aspects to generate new sales, expand volume of testing, consulting or clinical from current and new clients and obtain marketing and competitive information.
Contribute to establish and Implement annual sales plans and assists in the development and achievement of sales goals through effective interaction with clients, Company Project Development Advisor (PDA), scientists, sales, agents and other technical staff worldwide.
Assists with major accounts management and development in Israel.
 
Requirements:
Scientific Degree: Veterinarian, Pharmacist, PhD, MD, Engineering
0-5 years experience related to the Medical Devices Industry, Manufacturing, Regulations or Testing
Biomaterials Science, Medical Devices evaluation principles and standards, Medical Devices regulations.
Substantial, professional communications skills and analytical capabilities.
Outstanding motivation skills required. Willingness to travel both in Israel and internationally. Hebrew & English language proficiency.

 
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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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Biotechnology/Biology engineer 

  Biopharmax    Sharon Area   27/11/2006 
Category: QA - Quality Control, Biotechnology  
Education:   Position type: Full Time Employee  Experience:  
Area(s) of expertise desired: Academic, Validation  
Description:
Biotechnology/biology graduate for writing of validations.  
Requirements:
Very good English
Technical background - Advantage
No previous experience needed  
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Clinical and Quality Assurance Manager 

  Trendlines Group    North Area, Misgav Industrial Park ( Near Carmiel)   27/7/2016 
Category: QA - Quality Control, Clinical Research  
Education:   Position type: Full Time  Experience: 5 years 
Area(s) of expertise desired: Clinical Research, Medical Device, Orthopedics, Quality Assurance, Start-Up  
Description:
Manages all clinical aspects of a clinical study, including:
•Assesses operational feasibility and recommends study execution plan; participates in site monitoring visits as appropriate.
Select countries and sites for trial participation; develops relationships with K.O.L and site staff; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate;
•Design clinical trial protocols;

•Prepares/reviews site study documents
•Manages clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.)
•Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs:
Manages all aspects of quality assurance activities including:
•Ensure compliance with FDA and other regulatory affairs
•Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
•Establish quality assurance and quality control inspection and testing procedures
 
Requirements:
•Minimum 5 years clinical trial management experience in a medical device company - Mandatory
•Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for clinical trials is required;
•International clinical trial experience
•Minimum 2 years Quality Assurance experience in a medical device company - Mandatory
•Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements
•Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
•Experience working with subcontractors
•Excellent English - written and verbal
•Excellent communication and organizational skills, along with problem solving,

Travel- Travel abroad required per week, per month

Location: Misgav Industrial Park
 
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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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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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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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Clinical Research Scientist 

  Makro Technologies    Worldwide   28/11/2006 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Regulatory Affairs  
Education: Bachelors   Position type: Full Time Executive  Experience: 4 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research, Regulatory Affairs, Research  
Description:
Full Requirement : Complete Description: Drafts protocols, formulates requirements for clinical supplies and develops CRFs.As a Clinical Research Scientist, you will participate in preparation of routine clinical documents (i.e. protocols, CRFs, GMRs, ICFs, etc.). You will prepare complex documents with moderate supervision and routine documents independently as directed by supervisor ( AHT, CAP, CDP, IND documents, etc.). You will evaluate and select potential investigative sites with minimal to moderate supervision. You will organize and present complex aspects of protocol design at investigator and internal meetings. You will also conduct initiation/monitoring visits independently, coordinate and monitor activities at clinical/investigational sites with minimal supervision by medical monitors and/or project monitors. You may also participate in training/mentoring new hires. You will oversee and coordinate the collection of and/or collect pre-study documents independently. You will monitor safety with minimal to moderate supervision via any of the following: telephone contacts, study event reports, case report form/safety report reviews, contacts with regional clinical associates (RCA), RCA monitoring trip reports, or direct site visits. You will also participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and may serve as Study Team Leader as well as a member of a broad range of CR&D-related and ad hoc committees as needed. You may represent organizational unit at research-wide meetings and on committees, including Global Clinical Project Teams and Interdepartmental Project Teams. In addition, you will serve as a clinical science resource for the team(s), and for peers and/or subordinates.  
Requirements:
Qualification & Skills:A BS or equivalent with a minimum of 5 years related experience or a MS degree or equivalent in Life Sciences with a minimum of 4 years related experience is required. You must have good interpersonal skills. You must have the ability to work with and negotiate with colleagues to find solutions to resource/supplies/timeline issues.  
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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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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 company’s 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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