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Required Quality Sys Eng - P4
Yokneam, Israel
ID: 577277
Main Duties:
Member of integrated product team (IPT)- responsible for supporting activities required to ensure quality of the design though compliance with design controls.
Lead proactive design assurance activities facilitating the development and release of high-quality products.
Review and approve product design document- in accordance with design controls standards and companys policies. This includes but is not limited to design verification and design validation activities.
Parenting with R&D- ensures design control processes are maintained and continuously improved to ensure on-going compliance to all applicable regulation and standards.
Assure proper documentation and execution of design planning, inputs and outputs, design review, V&V, risk analysis and design change per company and regulatory requirements.
Support audits and compliance assessments of DHF and other program files to ensure quality and regulatory requirements are met.
Partnering with R&D, RA, Clinic affairs and BU, ensure that pre-release elements of risk management activities are properly conducted and included within the applicable risk management file.

In this role you will have responsibility for laboratory tests, preparation of working samples with advanced equipment under GMP and GDP procedures, producing results and in addition, any role related to the ongoing efficient functioning of the laboratory Our QC Analyst: Performs moderately complex tests and analyses to assure that products comply with established specifications Carries out calculations and prepares documentation that shows the results of tests performed Enters basic data into log books or computer databases. Performing and monitoring routine testing using laboratory instruments Recognizing problems during the analysis Supporting laboratory housekeeping, environmental and safety initiatives

looking for an Obesity Medical Scientific Liaison for the center-south region. In this role, you will be responsible for delivering high level medical and scientific expertise to internal and external stakeholders, within the obesity therapeutic area. You will be responsible for internal insight generation, scientific communications, and regional medical activities. In addition, you will work most of the time in the central and southern region of Israel with an 80 percent work rate in the field.
Your main accountabilities will be:
Development of professional relationships with external key opinion leaders and other stakeholders.
Leading scientific dialogue with key opinion leaders, including scientific presentations and personal meetings.
Identification of healthcare professional influencers within the obesity therapeutic area.
Drive internal and external scientific updates.
Drive local, regional, and international medical meetings and activities.
Generate insights from the field and participate in internal medical strategic planning.

As a Start-Up Team Manager, you will be responsible for executing the Start-Up team activities in clinical trials performed in Israel, ensuring compliance with local regulations, ICH-GCP, procedures and protocol requirements.
In addition, you will have the following responsibilities:
Manage and lead the Start-Up team, set and monitor performance targets and KPIs for the team and functional area in close cooperation with Israels Clinical Development Center (CDC) Director and with the Therapeutic Area (TA) Heads.
Ensure preparation and submission of local Clinical Trial Application to Health Authorities and Ethics Committees (ECs) to obtain all necessary regulatory approvals within defined timelines.
Deliver reliable, high-quality data and ensure study participants protection to activate sites prior to FPFV (First Patient First Visit) in the country.
Manage the lifecycle of clinical trial agreements/contracts, including sub-contractors, across trials.
Execute regulatory submissions of Clinical Trial Applications (CTA) and ongoing submissions and obtaining approvals.

As the Israel CDC Therapeutic Area Head, you will manage and lead the clinical research Therapeutic Area team and ensure that all clinical trial activities are carried out in compliance with all policies, procedures and local requirements.
You will also have the following responsibilities:
Ensure Clinical Therapeutic Area team set-up as per procedures and local regulatory requirements, unit processes & systems, resources and conduct of clinical trials in the CDC.
Drive implementation and execution of CDC trial delivery strategies and make sure risk plans are in place when needed in close cooperation with the CDC director.
Ensure performance management of the Clinical Therapeutic Area team, while guaranteeing the Clinical Research Unit goals are met.
Develop and maintain partnerships and effectively communicate with internal stakeholders, as well as external such as investigators, vendors, clients, KOLs, Ethics Committees and Health Authorities.
Inform internal stakeholders about trial/project related issues and the local therapeutic business scenario covering any current and/or potential changes in local trial related regulation.