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Job Search Results: Jobs 1 - 10 of 19  View Titles Only  Page 1 of 2
 
Title   Company Name     Location   Date  
$105,000+ Year... Pharmacy Regional Manager Interview Now! 

  LMN and Associates    Worldwide, Sudbury   16/5/2010 
Category: Regulatory Affairs, Healthcare  
Education: Bachelors   Position type: Full Time Manager  Experience: 2 years 
Area(s) of expertise desired: Clinical Research, Genetics, Pharmacokinetics, Pharmacology  
Description:
Attention: $105K Pharmacy Regional Manager Needed!!

The primary purpose of this position is to manage RX Managers within a specific region.
This is a field position so some travel would be required.

The Compensation:
Base Salary - $105,000 - $120,000

Benefits:
Outstanding comprehensive benefit plan

For consideration you must act now!
Send resume today to
lnembhardassociates@gmail.com

LMN and Associates
Executive Recruitment
 
Requirements:
Experience / Requirements:
Must have prior regional or management experience.
Must be a licensed pharmacist in Ontario or be able to obtain licensing.
Must be able to travel.  
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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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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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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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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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Director, Manufacturing 

  Scientific Search    Worldwide   14/3/2011 
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 Manager  Experience: 10+ years 
Area(s) of expertise desired: Bioanalytical Services, Biology, Manufacturing/Production  
Description:
Summary
This position is responsible for the technical oversight of biomanufacturing activities at contract manufacturing organizations associated with the production of critical raw materials, Drug Substance and Drug Product.
Responsibilities
Execute on time and cost the Manufacturing Supply Forecasts through oversight of third party manufacturers based in Japan, Israel and the US : Act as Person in Plant during manufacturing campaigns
Conduct technical audits of manufacturing operations to identify opportunities for Continuous Improvement at third party manufacturers
Technical review of batch documents
Trouble shoot manufacturing issues and support QA in Deviation and CAPA activities
Support QA in the technical review of Change Requests
Assist the Chief Technology Officer in the development of budgets
Provide data to populate the KPI program for Manufacturing
Other projects and assignments as required.
 
Requirements:
Requirements
BS Degree, in either bioengineering or a biological science.
Fifteen-plus years experience in manufacturing of biological products
Five-plus years in the management of biopharmaceutical manufacturing operations.
Excellent communication skills in Hebrew, both oral and written.
Profound knowledge of GMP requirements associated in biomanufacturing in the US and Internationally.
Knowledge of the engineering aspects of biopharmacecutical manufacturing plants
Experience working with CMO's
Goal oriented with a problem solving mindset
Proficiency with computers and major software packages, e.g. Microsoft Excel, Outlook, Powerpoint, Project
Excellent communication skills in English, both oral and written.
Travel - 25%
 
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experienced QA/RA professional 

  Li-Med - Asaf Azulay    Tel Aviv Area, Petach-Tikva   14/6/2016 
Category: QA - Quality Control, Biotechnology, Life Sciences, Medical Equipment, Regulatory Affairs, (, )  
Education: Masters   Position type: Full Time  Experience: 3 years 
Area(s) of expertise desired: GMP, Quality Assurance, Radiology, Regulatory Affairs  
Description:
We work with clients in the Medical Device field to build and implement their quality management system, as well as prepare regulatory strategy plans and files.  
Requirements:
B.A. in Mechanical Engineering/ Quality Engineering/ Biotechnology/ Life Sciences
2 years of experience with medical device Quality and Regulatory requirements (ISO13485, GMP)
Experience in writing and submitting regulatory documents for the European and American regulatory bodies
Experience with CE regulatory requirements
Has participated at least once in a CE quality/regulatory audit
Languages: proficient in Hebrew and English (reading, writing and speaking)  
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