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Job Search Results: Jobs 1 - 10 of 36  View Titles Only  Page 1 of 4
 
Title   Company Name     Location   Date  
Application Scientist 

  Azure PCR    Jerusalem Area, Jerusalem   1/8/2013 
Category: Biotechnology, Clinical Research, Management/Executive, Sales/Marketing  
Education: Bachelors   Position type: Full Time Manager  Experience: 2 years 
Area(s) of expertise desired:  
Description:
Azure PCR develops and commercialises leading algorithm technologies for automation of molecular diagnostics data-analysis incorporating both hardware and software platforms.
For the office in Har Hatzofim an Application Scientist needed to manage the transactional process from collaborative interest/trial through to revenue. In the short to medium term, we are focused mainly on the Routine Pathogen Clinical Diagnostic market and experience in this market segment is essential.
Responsibilities include:
- Planning: development of sales strategy and an annual sales plan, and independently identifying new opportunities.
- Scientific: manage research of relevant scientific opportunities and scientific articles for peer reviewed journals
- Implementation: Turn active interest into active users, manage communication and alignment with key internal stakeholders, approach key prospects, client services to key accounts, attend and present/exhibit in key conferences, supervise external communications and the preparation of key marketing materials
- Reporting: prepare client contact and BD pipeline reports, input customer requirements to R&D/product teams to ensure development optimization, revenues (past, present and forecasts).
- Supervisory responsibilities: two members of staff Sales Support and a Graphic Designer
 
Requirements:
Education in Life Sciences, Medicine, Pharmacology or related discipline. Candidates with
relevant industry experience will also be considered (for example healthcare economics
background, etc).
At least two years experience in routine pathogen clinical diagnostics.
Graduate degree in business and/or life sciences/medicine an advantage.
Extensive relevant business development experience in the areas of healthcare licensing
and sales transactions.
Proven deal leadership skills with track record of successfully closed deals.
Experience in developing business strategies.
Fluent English
PREFERRED
Healthcare / Medical Device / Pharma / Biotech Industry experience.
Routine diagnostics testing and/or real-time PCR experience.
Published in relevant peer review journal.
Other language(s) a plus.  
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Applications Development Engineer (position # 1213) o 

  Mengo    North Area, Yokneam   14/5/2010 
Category: Clinical Research  
Education:   Position type: Full Time  Experience:  
Area(s) of expertise desired:  
Description:

Please send your resume in a .doc format to jobs2@mengo.co.il
You must indicate at the headline of your email the no. of the position 1213


Duties & Responsibilities:
Responsible for all operational aspects of pre and clinical trials including all related logistics, communication and coordination with the operating room staff.
Budget, follow up and control of project plans
Managing the technology and clinical databases at DHF standards.
Take active part in integrating technological solutions into the product/application being developed.
Managing tasks with external organizations and staff (e.g. hospitals, labs, suppliers).
Testing of prototypes for clinical performance and engineering evaluation.
Responsible for managing all stages of pre and clinical trials from design to final report including procedural monitoring and documentation (protocols, instruments and accessories order, sterilization etc).
Follow PDI processes related to product definition to release.
 
Requirements:
Academic B.Sc. or preferred M.Sc in either: bio-medical engineering, medical science, medicine (MD) or similar.
At least 3 year experience in a medical device company.
Ability to design and support clinical trials as well as to execute technical tests (protocols, implementation, reports).
Good technical capabilities and creativity.
Familiarity with operating rooms environment and equipment and with surgical procedures - advantage.

Personal
English fluent talking and high level writing - mandatory.
Quick learning curve.
High diligence.
Assertive.
High pressure and workload capabilities.
Teamwork oriented.
 
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Assistant VP RA/QA 

  Mengo    North Area, Cessaria   17/10/2010 
Category: Clinical Research, Regulatory Affairs  
Education:   Position type: Full Time Employee  Experience: 2 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research, Quality Assurance, Regulatory Affairs  
Description:

i. Assist VP RA/QA in the following:
1. Manage the informed consent document
2. Manage safety reporting
3. Assist in the preparation of documentation for the study approval and running phases (submissions, responses to regulatory authorities, investigator brochure, progress/annual reports, amendments etc)
4. Maintain Company's Document Control center  
Requirements:
Assist Clinical Quality Manager in the following:
1. Assist Clinical Trial Managers in maintaining in-house study binders
2. Review monitoring reports
3. Assist in follow up of post audit CAPA
4. Review protocol deviations
iii. Israel CRA
1. Perform monitoring trial activities in the local Israeli sites
2. Experience/Skills Required
a. 2-3 years minimum work experience as a CRA
b. High level of English writing skills
c. Experience preparing informed consents and other clinical study related documentation (investigator brochure, progress/annual reports etc)
d. Excellent communication, organizational and recordkeeping skills required
e. Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands

3. Required Education
a. Formal CRA training (e.g. BioForum CRA course or in-house CRO courses)
b. Bachelors degree in life science-related field
c. Related degree with an equivalent combination of education and experience will be con
 
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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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CEO is needed for a pharmaceutical company 

  Mengo    Jerusalem Area, jerusalem   23/9/2009 
Category: Biotechnology, Clinical Research, Management/Executive, Pharmacy/Pharmacology, "  
Education: MBA   Position type: Full Time Executive  Experience:  
Area(s) of expertise desired: Executive, Oncology, "/CEO  
Description:
Experience with accompanying Clinical Trials in the field drugs , preferably oncology drugs .


Experience in Business Development.


Experience from a startup company and preferably from a public company.


Experience with raising capital - as advantage.


The role includes travelling abroad.
 
Requirements:
Experience with accompanying Clinical Trials in the field drugs , preferably oncology drugs .


Experience in Business Development.


Experience from a startup company and preferably from a public company.


Experience with raising capital - as advantage.


The role includes travelling abroad.
 
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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 companys 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 Application Development Scientist (position # 1296) o 

  Mengo    North Area, Yokneam   14/5/2010 
Category: Clinical Research, Medical Equipment  
Education:   Position type: Full Time  Experience: 4 years 
Area(s) of expertise desired: Clinical Research, Surgery  
Description:
Please send your resume in a .doc format to jobs2@mengo.co.il
You must indicate at the headline of your email the no. of the position 1296

Affiliation: reporting to the Medical Director

Job Description and Main Tasks:
Acquisition, analysis and reporting of application related technological, scientific and clinical data including and maintenance of a clinical and scientific database (scientific literature, internet, market reports, etc.).
Professional support of the Medical Director activities including: writing protocols, multi-centers studies, coordination with physicians, laboratories and hospitals, issuing reports, etc.
Writing reports for in-house and external purposes and preparing multimedia presentations.
Assisting in writing scientific papers.
Working closely with bodies within and outside the company including CROs, clinical monitors, MDs nurses, etc.
Active participation in the R&D Application Group activities.
 
Requirements:

Qualifications:
Academic M.Sc. or preferred Ph.D. in either: bio-medical engineering, medical science, biology, medicine (MD) or equivalent.
At least 5 year experience in a medical device company.
Mother tongue level English.
Ability to read and analyze high volumes of scientific data.
Journal level scientific papers writing capability.
Familiarity with operating rooms environment and equipment and with surgical procedures.
Familiarity with regulatory processes (FDA, CE, IRB) - advantage.
Reliability, team worker, excellent inter-personal relationships.


 
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Clinical Data Manager 

  Makro Technologies    All   28/11/2006 
Category: Biotechnology, Clinical Research, data management  
Education: Bachelors   Position type: Full Time  Experience: 5 years 
Area(s) of expertise desired: Clinical Data Management, Clinical Research  
Description:
Responsibilities
In this role, you will handle detailed Data Management issues for all Phases of clinical trials (Phase 1-4) including oversight of CRO data Management activities.

Additionally, you will participate in study planning and initiation data activities (e.g., CRF design, database design, annotated CRF, and edit check/Data Management Plan development in conjunction with the clinical study team ensuring application of Cubist data standards.

You will also ensure the accuracy, completeness, and consistency of clinical databases, carry out safety and microbiology data loading/transfer procedures, prepare materials for NDA vendors, actively participate in the NDA and e-submission process, prepare ad hoc data listings and review analysis tables, listings, and figures for consistency and accuracy.

Moreover, you will be expected to work closely with lead study and Project managers to develop timelines and review budgets and contracts to ensure departmental and corporate clinical trial data management objectives are met, as well as develop and SOPs, departmental guidelines, data standards and other activities to support DM and biostatistics as needed.
 
Requirements:
Qualifications

Top candidates for this position will have a minimum of a BS/BA in a scientific discipline or equivalent, a minimum of 5 years experience as a Data Manager in a CRO or Pharmaceutical/Biologics/Medical Device company, and experience as a lead CDM managing studies from preparation through close-out (including data management activities related to study conduct, study completion, and archiving of study materials).

Demonstrated experience with a data management system (e.g., Clintrial or Oracle Clinical), ability to work interdependently with minimal supervision, and excellent written and oral communication skills are required.

Familiarity with coding of medications, medical conditions, and AEs/SAEs using MedDRA and WHODRUG dictionaries is necessary;

Proficiency in basic SAS and/or JMP (preferred) or a demonstrated ability to learn basic programming skills is fundamental;

Familiarity with ICH GCP as well as general knowledge of industry practices
and standards (CDISC, SDTM) are essential.
 
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clinical Operations Coordinator 

  Confidential    Tel Aviv Area   4/11/2013 
Category: Clinical Research  
Education: Masters   Position type: Full Time Employee  Experience: 2 years 
Area(s) of expertise desired: Academic, Clinical Data Management, Clinical Research, Other, Research  
Description:
 
Requirements:
 
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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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