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Job Search Results: Jobs 1 - 10 of 51  View Titles Only  Page 1 of 6
 
Title   Company Name     Location   Date  
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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Sr. Principal Biostatisticians 

  Makro Technologies    All   28/11/2006 
Category: Biotechnology, Clinical Research, Medical Equipment  
Education: Masters   Position type: Full Time  Experience: 5 years 
Area(s) of expertise desired: Biostatistics, Clinical Data Management, Clinical Research, Regulatory Affairs  
Description:
Full Requirement : Responsible for all statistical tasks on the assigned clincial trials, e.g. clinical trial design/planning, analysis plan, reporting activities including programming tasks, exploratory analyses and additional analyses to support publications. Write statitical methodology section of protocol, statistical section of clinical trial report and review clinical trial report. Oversee CRO deliverables for trials contracted out. Minimum requirements MS in Statistics with at least 6 years of pharmaceutical experience or PhD in Statistics with at least 2 years of experience for Sr. Prinicipal Biostatistician. Solid, hands-on experience as a lead statistician in protocol development, analyses, study reports, for Phase II-III clinical trials. Strong statistical skills and good knowledge of SAS. Good knowledge of drug development process. Project management skills. Experience in supporting clincical development plan and/or NDA submissions. Experience participating in internation teams. Very good oral and written communication and negotiation skills.  
Requirements:
Education:
Phd/MS in Statistics
Required years of experience Five - Seven Years in Pharma or Biotech industry  
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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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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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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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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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Operation Deputy Manager 

  confidential    All, Rehovot   26/12/2011 
Category: Biotechnology, Engineering, Chemistry, Life Sciences,  
Education:   Position type: Full Time Team Leader  Experience:  
Area(s) of expertise desired:  
Description:
The position includes: production of company products
Maintaining and co-managing the pilot plant
Managing as well as " hand" working
the job is for Rehovot and Hedera  
Requirements:
Relevant education- Engineer/practical Engineering degree or technologist in the fields of Chemistry/food/ Biotech/engineering or first degree (Bsc) in Biotechnology
Ability for intensive and hard work and unusuall working times
wanted yet not obligated:
previous experience in producing of plant extracts; work with mechanical manufacturing devices, such as centrifuges; reactors; filtration equipment and clean room work
background and experience in food or biotechnology industry  
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