דרושים » רפואה ופארמה » Senior CT Product & Clinical Support Application Specialist

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

The role will be Hybrid and require visits to the sponsor office weekly.

Sponsor requirements are:
Strong local experience and knowledge in Israeli regulations and submissions.
Beside the role being a lead role, it requires a lot of local regulatory knowledge.
Fluency in Arabic.


Essential Functions

Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.

Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring therapy to patients in need, no matter where they live. Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve. We are a dynamic, fast-paced company operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile, and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us! The Medical Affairs Manager is the medical face of the company. His/her value lies in his/her scientific and clinical expertise and ability to build strong relationships with the community and academic physicians. This allows for information to flow freely between the medical community and the company. The Medical Affairs Manager works closely with the marketing team. He/She manages the medical relationship with the medical divisions of the partners abroad.

Responsibilities:

* Medical expertise regarding the assigned therapeutic area and product, including keeping updated on medical developments in the field, clinical and research information, and sharing it with the marketing teams.
* Participation in national and international medical conferences.
* Participate in formalizing medical and marketing strategy through analysis of scientific materials.
* Instructing physicians before relevant presentations.
* Meetings with Medison’s business partners in Israel and abroad.
* Provide training to the marketing teams on topics relevant to the marketed products
* Maintaining scientific and medical contact with key opinion leaders (KOLs) and decision makers.
* Serve as the local medical information service for the assigned products, and answer medical questions according to the policy signed with the relevant business partner.
* Create and execute an annual medical plan for each product.
* Supporting business development processes.
* Supporting the inclusion of products into the national health basket in coordination with the regulatory and market access departments.
* Working in collaboration with the Marketing and Market Access Department
* Working in accordance with all compliance guidelines, including local and partner regulatory guidelines
* Leading early access programs and clinical trials feasibility.


City:
Petah Tikva

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.

Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Assist with periodic review of study files for completeness.

Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.

Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.

May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

we are looking for a Senior Medical Manager.
Responsibilities:
Lead a medical team responsible for the design, development, and deployment of features and product lines within (in partnership with the Product and Engineering teams). Specifically related to flagship Risk Adjustment Solution.
Regular data analysis and clear presentation of conclusions to direct business and product decisions
Medical validation of product and features
Closely work with developers data scientists, and data analysts to bring medical and medical-product expertise to all aspects of R&D
Support marketing and sales teams in the development of marketing materials, delivering webinars, attending conferences and sales demos
Manage a team of analysts (medical students) to support your efforts in the above

In this onsite role, the Team Leader Quality Operations leads a team of Quality Engineers that support manufacturing processes and projects, as well as provide quality oversight to the Engineering department within a multi-functional team environment for medical devices. This Team Leader will lead QEs, projects and tasks, from product inception through commercial product and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all applicable regulatory requirements. Additionally, this role will identify and implement improvements within the Quality Management System. The Senior Quality Engineer will be a strong advocate for product, process, and system quality at all stages of manufacturing processes.

Essential Duties and Responsibilities
Exhibit a strong quality first mentality and ensure that products, processes and quality are held to the highest standard, adhere to all company policies, KPIs and follow all safety rules and safety procedures
Lead QEs daily activities, provide support, guidance, set objectives, monitor performance, and follow-ups as required.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
Responsible to provide support to manufacturing related processes, such as (but not limited to) approval of equipment qualification, process risk management and pFMEA, and process validation documents (URS, IQ, OQ, PQ, etc.), and responsible to review, and approve product development DHF documentation (product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, OOSs, product transfer to operations, etc.) in relation to medical devices.
Lead the Quality involvement in development and maintenance of product and hazard analysis in accordance with West policies and procedures.
Provide Quality oversight of qualification/validation/review and approval of documentation and reports/design controls activities to other QEs
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects.
Responsible to review and approve process development QMS procedures and work instructions and support QMS activities as required.
Liaison with company and customers on Quality matters related to engineering projects.
Support routine sterilization validation monitoring activities.

The Medical Affairs Manager is the medical face of the company. His/her value lies in his/her scientific and clinical expertise and ability to build strong relationships with the community and academic physicians. This allows for information to flow freely between the medical community and the company. The Medical Affairs Manager works closely with the marketing team. He/She manages the medical relationship with the medical divisions of the partners abroad.

Responsibilities
Medical expertise regarding the assigned therapeutic area and product, including keeping updated on medical developments in the field, clinical and research information, and sharing it with the marketing teams.
Participation in national and international medical conferences.
Participate in formalizing medical and marketing strategy through analysis of scientific materials.
Instructing physicians before relevant presentations.
Meetings with our business partners in Israel and abroad.
Provide training to the marketing teams on topics relevant to the marketed products.
Maintaining scientific and medical contact with key opinion leaders (KOLs) and decision makers.
Serve as the local medical information service for the assigned products, and answer medical questions according to the policy signed with the relevant business partner.
Create and execute an annual medical plan for each product.
Supporting business development processes.
Supporting the inclusion of products into the national health basket in coordination with the regulatory and market access departments.
Working in collaboration with the Marketing and Market Access Department
Working in accordance with all compliance guidelines, including local and partner regulatory guidelines.
Leading early access programs and clinical trials feasibility.

Lead and manage clinical regulatory submissions, including IDE submissions, IRB/EC applications, amendments, and ongoing study maintenance.
Serve as the regulatory lead for US and EU clinical investigation activities, supporting first?in?human, feasibility, and pivotal studies.
Prepare, review, and maintain clinical regulatory documentation, including protocols, Investigators Brochures, clinical risk sections, and regulatory responses.
Support regulatory strategy development for clinical programs, ensuring alignment with development, clinical, and business objectives.
Act as a primary regulatory interface with FDA and European regulatory bodies related to clinical studies.
Collaborate closely with Clinical, R D, Quality, Biostatistics, Operations, and external clinical partners/CROs.
Participate in cross?functional discussions supporting new product development and clinical evidence

In this role, responsibility spans the full brand lifecycle. This includes preparing, updating and executing robust Brand Plans that deliver both short- and long-term market share and profitability targets. Market and customer insights are gathered and interpreted to shape strategy: segmentation, SWOT, competitor analysis and sector developments are translated into clear operational plans that stay current in a fast-changing environment. Strategic decisions are led to improve business performance, while brand strategy and plans are developed and implemented in close collaboration with Sales Management, Medical, Regulatory, Diagnostic and Market Access. Synchronisation with the cross-functional team is maintained through clear, continuous communication and strong relationships, increasing recognition and awareness of the brand strategy across AstraZeneca. Close bilateral communication with the product promotion team via FLSMs ensures strategic and operational plans are implemented effectively across Israel, with regular feedback loops and follow-up on execution. The role also maintains effective links with global brand teams and marketing groups to share information and effective practices. Field presence is key: dual visits with the product promotion and medical teams help identify and solve issues quickly, while strong relationships are built and maintained with Opinion Leaders to shape and support the brands impact.

We are seeking a Lead Systems Engineer to drive Point-of-Care Ultrasound systems engineering activities across the full product lifecycle.
Job Description
Key Responsibilities:
Lead and manage system-level requirements and specifications throughout product development
Drive system verification and validation activities, including end-to-end system testing
Act as the primary interface between Algorithm, Software, and Verification & Validation (V&V) teams
Lead product risk management activities in accordance with regulatory and quality standards
Drive resolution of complex technical issues to ensure project milestones and goals are met
Collaborate closely with Program Management to support scheduling, mitigate technical risks, and inform decision-making through sound engineering judgment.