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Join Us as a Senior Country Approval Specialist - Make an Impact at the Forefront of Innovation
The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

What You'll Do:
Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Provide local regulatory strategy advice (MoH &/or EC) to internal clients.
Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
Ensure guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
Act as a key-contact at country level for all submission-related activities.
Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings.
Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieve companys target cycle times for site activations.
Prepare the regulatory compliance review packages, as applicable.
Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
Develop country specific Patient Information Sheet/Informed Consent form documents.
May assist with grant budgets(s) and payment schedules negotiations with sites.
Assist in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.
Support the coordination of feasibility activities, as required, in accordance with agreed timelines.
Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
Oversee country study files and ensure that that they meet PPD WPDs or client SOPs.
Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Direct/mento other SIA individuals assigned to support projects of responsibility, as appropriate
Proactively identify issues or anomalies in the regulatory process of a study, resolve or escalate as appropriate.

The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs. This opportunity is an exciting prospect for a big pharma company and for a new division focused on Oncology/Cell therapy.




What You'll Do:
Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.

Supporting the facilitation of site start up and communication with internal and external team mem-

bers to ensure prompt site approval and study timelines are achieved.

Support sites and study teams to achieve rapid site start up

Essential Functions:
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
Provides project specific local SIA services and coordination of these projects.
May have contact with investigators for submission related activities.
Key-contact at country level for either Ethical or Regulatory submission-related activities.
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieves PPDs target cycle times for site.
May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
May develop country specific Patient Information Sheet/Informed Consent form documents.
May assist with grant budgets(s) and payment schedules negotiations with sites.
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs in Israel.


What You'll Do:
Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

Career development with an international company where you can grow the career you dream of.

Competitive salaries, bonus potential and excellent package of benefits..

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
What You'll do:

Provide Clinical support in the cath-lab for TAVI products.

Provide Clinical support of the existing customer base and development of new customers.

Build personal relationship with Customers, providing support to their scientific and technological needs and enhancing the penetration and usage of Abbott products.

Product training for doctors and assistants as well as on-site support for interventions.

Planning and implementation of workshops in the sales area.

We are looking for a highly skilled and motivated Senior Academic Editor to lead and support the preparation, writing, and submission of peer-reviewed scientific publications related to AEYE Healths clinical, technological, and regulatory activities.

This is a cross-functional role that requires excellent academic writing skills in English, strong collaboration across departments (Clinical, R&D, Product, Regulatory), and the ability to communicate complex scientific data in a clear and compelling way.

The ideal candidate has a background in life sciences, biomedical engineering, or clinical research, and a proven track record in academic publishing-preferably in the fields of medical devices, SaMD, AI in healthcare, or digital health.

Responsibilities:

Write, edit, and manage scientific manuscripts, abstracts, posters, and white papers for submission to peer-reviewed journals and scientific conferences.

Collaborate with internal teams (Clinical, R&D, Data Science, Regulatory) to gather and validate data for publication.

Conduct literature reviews and maintain up-to-date knowledge of relevant clinical and scientific developments.

Manage the end-to-end publication process, including journal selection, formatting, submission, and peer-review response.

Support clinical and regulatory documentation when relevant, such as clinical evaluations, study reports, or white papers.

Maintain a pipeline of upcoming publications and coordinate timelines with key stakeholders.

Ensure all scientific materials align with our Healths strategic positioning and messaging.

We are looking for an experienced clinician to serve as the medical voice inside our AI organization. In this role, you will work shoulder-to-shoulder with AI researchers, product managers, clinical managers, and external partners to shape clinical AI products that are safe, useful, and genuinely valuable to patients and care teams.

You will act as the bridge between medicine and AI research - bringing deep clinical judgment to the design, evaluation, and continuous improvement of AI systems that touch real patient care. This is a hands-on, cross-functional role for someone who is as comfortable dissecting a model's clinical failure modes as they are defining the next product opportunity.

What you'll be doing
Partner directly with AI researchers as the resident domain expert, contributing clinical insight throughout the development of innovative clinical AI products - from framing the problem to validating the solution.
Design and lead the clinical evaluation of AI products, defining what "good" looks like from a medical standpoint and rigorously assessing model outputs for safety, accuracy, and real-world clinical value.
Serve as the medical product owner, working alongside product managers, clinical managers, the CMO, and external partners to identify unmet needs, surface gaps, translate clinical requirements into product specifications, and derive new features from them.
Ground product and research decisions in clinical reality, ensuring that what we build fits how medicine is actually practiced and improves outcomes for patients and clinicians.
Communicate clearly across disciplines - translating clinical nuance for technical teams and technical trade-offs for clinical and business stakeholders.

Required Experienced Clinical Research Associate- Israel
Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions:
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

We are looking for a clinician with a background in medical psychology to join our multidisciplinary team as Therapeutics Program Manager. The ideal candidate will demonstrate the ability to translate psychological interventions into protocols that fit a digitized format, with a product-oriented mindset, strong English writing skills and a commitment to integrative, holistic, and patient-centered approaches to chronic disease management.

What Youll Do
Clinical Protocol & Framework Development - Develop, research, and refine psychological therapeutic protocols and care frameworks grounded in evidence-based, integrative, and holistic approaches. Transform these into concise, actionable treatment pathways.
‍Digital Translation of Therapeutic Content - Create psychological therapeutic protocols that can integrate into digital therapeutics and product features. Collaborate with product, design, and engineering teams to ensure clinical accuracy and usability in digital implementations.
‍Clinical Content Creation - Write and edit high-quality clinical materials, care protocols, and white papers. Review and synthesize clinical literature with scientific rigor and clarity.
‍Expert Collaboration - Engage in discussions with physicians, therapists, scientists, and other clinical domain experts. Capture essential insights and integrate them into well-structured, clinically meaningful content.
‍Research & Literature Analysis - Conduct literature reviews on therapeutic modalities, chronic disease management, integrative care, and rehabilitation sciences. Assess emerging evidence and incorporate validated insights into therapeutic frameworks.
‍Holistic & Integrative Perspective - Maintain a systems-level, whole-person viewpoint blending conventional clinical practice with complementary and lifestyle-based interventions. Stay informed about developments across integrative medicine and digital health.

We are looking for a Therapeutics Program Manager to join our multidisciplinary team. This role is ideal for someone with a strong clinical background or deep experience working within clinical, therapeutic, or healthcare environments, whether from medicine, rehabilitation or allied health. The ideal candidate will demonstrate the ability to translate therapeutic interventions into protocols that fit a digitized format, with a product-oriented mindset, strong English writing skills and a commitment to integrative, holistic, and patient-centered approaches to chronic disease management.
Work Environment
This full-time role is based in our office in Ramat Gan, offering the opportunity to collaborate closely with our dynamic team in person.

Key Responsibilities
Clinical Protocol & Framework Development
Develop, research, and refine therapeutic protocols and care frameworks grounded in evidence-based, integrative, and holistic approaches.
Transform complex, multidisciplinary clinical discussions into concise, actionable treatment pathways.
Digital Translation of Therapeutic Content
Create therapeutic protocols that can integrate into digital therapeutics and product features.
Collaborate with product, design, and engineering teams to ensure clinical accuracy and usability in digital implementations.
Clinical Content Creation
Write and edit high-quality clinical materials, care protocols, and white papers.
Review and synthesize clinical literature with scientific rigor and clarity.
Expert Collaboration
Engage in discussions with physicians, therapists, scientists, and other clinical domain experts.
Capture essential insights and translate them into well-structured, clinically meaningful content.
Research & Literature Analysis
Conduct literature reviews on therapeutic modalities, chronic disease management, integrative care, and rehabilitation sciences.
Assess emerging evidence and incorporate validated insights into therapeutic frameworks.
Holistic & Integrative Perspective
Maintain a systems-level, whole-person viewpoint blending conventional clinical practice with complementary and lifestyle-based interventions.
Stay informed about developments across integrative medicine and digital health.

This is a full-time on-site role for Postdoc, Ph.D. or M.Sc. positions. The responsibilities include conducting synthetic microbiology research, performing data analysis, engaging in laboratory activities, and mentoring undergraduate students. Candidates will contribute to the academic community by publishing research findings and participating in interdisciplinary projects.