לוח משרות דרושים מחקר ברפואה

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 our 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.

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.

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.

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.

Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff, and external clinical site staff involved in study preparation and delivery providing both matrix leadership and project management of study activities within the country(ies).
Serves as the operational point-of-contact between the central study team and within-country(ies) study team. The LDL collaborates closely with local medical and regulatory affairs staff to align local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within country(ies). Leads selection of sites within country(ies) and is accountable for local study performance.
Accountable for within-country delivery of assigned studies to time, budget, and quality expectations as defined in the clinical development plan and study protocol as well as in local/regional regulations, IND/GCP/ICH-guidelines, and procedures. Ensures quality and integrity of clinical studies by taking on appropriate business management monitoring activities.
Ensures development and maintenance of country study plan and that critical study timelines related to study activities within-country(ies) are accurately forecasted and achieved, including budgets, resource estimates, milestones, timelines, quality and risk planning, and that recruitment targets, patient recruitment cycle times, data, and audit/inspection quality are met. Provides troubleshooting and problem resolution support for within-country study team to ensure productive, efficient study delivery. Ensures necessary supplies are available at sites and manages local supply inventory.
Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders and to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators, and other reports. Review all study databases to ensure 100% accuracy.
Ensures development of country/site-level risk assessment to proactively identify risks, develop a mitigation plan, and escalate issues and risks that may impact study delivery.
Will review and approve monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.
May provide feedback on performance, capabilities, and competencies of local study members to line management.