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experienced QA/RA professional |
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Category: |
QA - Quality Control, Biotechnology, Life Sciences, Medical Equipment, Regulatory Affairs, עברית ואנגלית ברמה גבוהה מאוד (קריאה, כתיבה ודיבור)
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Education: |
Masters |
Position type: |
Full Time |
Experience: |
3 years |
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Area(s) of expertise desired: |
GMP, Quality Assurance, Radiology, Regulatory Affairs
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Description: |
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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.
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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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Scientific Assistant to VP R&D |
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Category: |
Biotechnology, Life Sciences, Regulatory Affairs, מדעי הצמח
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Education: |
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Position type: |
Full Time Employee |
Experience: |
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Area(s) of expertise desired: |
Biology, Botany, Microbiology, Molecular Biology, Other, Postdoctoral, Project Management, Regulatory Affairs, Research, agriculture, מדעי הצמח,
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Description: |
לחברת ביוטק ברחובות דרוש /ה אדמיניסטרטור /ית למחלקת פיתוח. האדמיניסטרטור /ית אחראי /ת על ניהול התהליכים הפנימיים והחיצוניים במחלקה כולל מתן תמיכה לסמנכ"ל הפיתוח בפעילויות הניהוליות: כגון הכנת דו"חות, מצגות ופיקוח על גורמים מחקריים חיצוניים.
תיאור התפקיד:
- אחראיות על קבלת טכנולוגיות חדשות.
- מעקב וניהול פרויקטים הכולל הכנת דו"ח חודשי.
- תהליך רגולציה לעבודה עם צמחים טרנסגניים: להכין ולטפל בבקשות לניסויים מקומיים
ולטפל במשלוחים ברחבי העולם.
- אחריות כוללת על השתתפות החברה בכנסים מדעיים בינלאומיים.
- בנייה ותחזוקה של ארכיון הנתונים של המחלקה.
- עריכת מסמכי המחלקה בשפה האנגלית.
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Requirements: |
תואר שני ו/או שלישי במדעים מדוייקים ו/או במדעי החקלאות/הצמח.
- תואר מנהל עסקים - יתרון.
- ידע בסיסי בהנדסה גנטית בתחום הצומח.
- אנגלית ברמה גבוהה מאוד.
- יכולת תפיסה מהירה.
- נכונות לעבודה אדמיניסטרטיבית מרובה. המשרה מיועדת לנשים וגברים כאחד.
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Medical expert |
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Category: |
Life Sciences, Medical Management, Regulatory Affairs
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Education: |
Doctorate |
Position type: |
Full Time Employee |
Experience: |
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Area(s) of expertise desired: |
Clinical Research, Materials/Inventory Control, Medical Affairs, Medical Records, Medical Writing, Pharmacology
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Description: |
ROLE AND RESPONSIBILITIES
The candidate will model, collect and write information of medical and wellness conditions, manage dictionaries and ontologies to help categorize diseases and phenotypes and will be involved in the definition of scope and requirements for the medical project. Responsibilities are as following:
• Definition of user cases and database model for the Medical Navigator project.
• Designation of relevant data sources available for implementation.
• Work with bioinformatics and software teams to model the medical information and define requirements.
• Writing of medical content for specific diseases, health conditions, risk factors, wellness and more.
• Definition of the QA process and SOP for medical content implementation.
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Requirements: |
• MD- a MUST
• Clinical experience
• English at mother tongue level
• Experience working with biomedical databases – an advantage
• Excellent and demonstrated scientific writing skills
• Creative, initiative and ambitious candidate
• Details oriented
• Collaborative team member with good communication skills
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RA Project Manager |
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Category: |
Biotechnology, Pharmacy/Pharmacology, Regulatory Affairs
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Education: |
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Position type: |
Full Time Employee |
Experience: |
2 years |
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Area(s) of expertise desired: |
Biology, GMP, Regulatory Affairs
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Description: |
Omrix, a J&J Bio-Pharmaceutical company, is seeking RA Project Manager for its’ Nes-Ziona or Jerusalem Site. The position includes Providing Regulatory Affairs support, Generating and managing submission documents for new products or changes to existing files;
Assessing company activities, including new efforts and modifications for existing products, for regulatory impact and creating and executing regulatory strategies for implementation; Tracking requirements of regulatory agencies and implementing file updates accordingly.
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Requirements: |
Qualifications:
Degree in biology, chemistry, or another related field.
At least 2 years of Similar industry experience (QA / Medical Device) -
Experience in biologics Regulatory Affairs an advantage.
Familiarity with regulatory requirements
Working experience with regulatory authorities
Excellent communication, interpersonal and organization skills.
Computer skills: Microsoft Office applications.
Language: mother-tongue level English required
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regulatory specialist |
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Category: |
Regulatory Affairs
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Education: |
Bachelors |
Position type: |
Full Time |
Experience: |
3 years |
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Area(s) of expertise desired: |
Clinical Data Management, Regulatory Affairs, רגולציה, Regulatory
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Description: |
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Requirements: |
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Director, Manufacturing |
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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
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Education: |
Bachelors |
Position type: |
Full Time Manager |
Experience: |
10+ years |
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Area(s) of expertise desired: |
Bioanalytical Services, Biology, Manufacturing/Production
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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.
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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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Junior Sales Representative Surgical |
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Category: |
QA - Quality Control, Biotechnology, Engineering, Chemistry, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing
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Education: |
Bachelors |
Position type: |
Full Time |
Experience: |
3 years |
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Area(s) of expertise desired: |
Medical Affairs, Medical Device, Sales
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Description: |
Position: Junior Sales Representative Surgical (3)
Location: Central Israel (Tel Aviv)
Covidien
It's a new era with nothing but promise. Today, Covidien is more than a leading provider of medical devices, supplies and pharmaceuticals. We’re a $10 billion company with over 40,000 employees who are passionate about helping doctors, nurses, and other medical industry professionals to as effective they can be.
A company with a true global mindset, Covidien has forged dynamic partnerships with medical professionals around the world. In our role as an integral collaborator, we help identify patient needs and translate them into proven procedures and products that improve and save lives.
As a Junior Sales Representative Surgical focused on our prestigious products, you will work closely with doctors, surgeons and specialist groups, selling into hospitals and a variety of practices across the centre of Israel and Central region - Jerusalem.
In return, we will provide you with world-class training, frequent development opportunities, rewarding benefits and the opportunity to work in a varied, challenging role with a large scope for demonstrating your independence, innovation and your talent for sales.
As a Junior Sales Representative your main responsibilities will involve:
• Selling a portfolio of world renewed Surgical products across your established customer base
• Increasing sales in line with agreed budgets
• Building on well established relationships, to become an expert advisor to healthcare professionals
• Being resilient, a strong negotiator and advocate for your products whilst identifying new opportunities in your market place
• Cooperating with Customer Service Department
• Participating in preparation and monitoring outcome of tender offers within the territory
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Requirements: |
As a Junior Sales Representative your skills and qualifications will ideally include:
• Comprehensive selling experience B2B business (preferably in medical environment)
• Previous sales experience or the desire to develop your sales ability
• Good command of English to business standard
• A full clean Driving License
What we will be looking for in you:
This role will suit a performance-driven young individual who enjoys working in a competitive environment and seizes the opportunity to get the awards that over-achievement brings. Ideally, you’ll have excellent presentation and negotiation skills and genuinely enjoy building long-term, trusting relationships with your customers.
Contact:
To apply follow the link:
http://www.tycohealthcarecareers.com/tycohcinternational/jobboard/NewCandidateExt.aspx?__JobID 9449
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Assistant VP RA/QA |
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Category: |
Clinical Research, Regulatory Affairs
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Education: |
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Position type: |
Full Time Employee |
Experience: |
2 years |
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Area(s) of expertise desired: |
Clinical Data Management, Clinical Research, Quality Assurance, Regulatory Affairs
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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
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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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$105,000+ Year... Pharmacy Regional Manager “Interview Now!” |
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Category: |
Regulatory Affairs, Healthcare
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Education: |
Bachelors |
Position type: |
Full Time Manager |
Experience: |
2 years |
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Area(s) of expertise desired: |
Clinical Research, Genetics, Pharmacokinetics, Pharmacology
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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
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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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VP/ Director RA / QA |
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Category: |
QA - Quality Control, Biotechnology, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs
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Education: |
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Position type: |
Full Time Executive |
Experience: |
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Area(s) of expertise desired: |
Medical Device, Pharmacology, Quality Assurance, Regulatory Affairs
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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
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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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