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Required Country Approval Specialist - FSP- Israel
Position Overview:
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.

Join Us as a Clinical Trial Coordinator - Make an Impact at the Forefront of Innovation
As part of our global team, youll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coordinator, you'll coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. You will act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements.
What Youll Do:
According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
Provides system support (i.e. GoBalto & eTMF).
Supports RBM activities.
Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
Reviews and tracks local regulatory documents.
Transmits documents to client and centralized IRB/IEC.
Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
Maintains vendor trackers.

As a Sales Representative in Gastroenterology, you will be responsible for bringing our brand strategy to life in the field through strong execution, trusted customer partnerships, and a deep commitment to patient-centered care. You will manage your assigned territory and key accounts with accountability and agility, building long-term relationships that help uncover customer needs and deliver meaningful solutions.
You will operate with integrity at all times, guided by our company Code of Business Conduct, company policies, and all applicable laws and regulations. In this role, you will help shape a high-performing, collaborative culture where customers, patients, and colleagues can thrive.
Responsibilities
You will deliver strong sales performance against brand KPIs, financial targets, and marketing objectives, working to exceed expectations wherever possible.
You will prepare each customer call with clear SMART objectives and follow up with thoughtful post-call evaluation to continuously strengthen your impact and effectiveness.
You will handle objections, concerns, and misunderstandings with confidence and professionalism, guiding conversations toward clear and actionable next steps.
You will proactively anticipate and respond to customer needs, expectations, and challenges, building trusted relationships that create value for both our company and your customers.
You will develop and execute a call plan that achieves required call metrics and optimizes coverage and frequency among key customers to maximize access and sales opportunities.
You will continuously deepen your understanding of customer needs, market dynamics, competitors, accounts, disease state, and product and clinical knowledge, and you will share these insights with your in-field team, brand team, and sales manager to help drive alignment and informed decision-making.
You will communicate our value proposition clearly and compellingly to healthcare providers, while identifying, developing, and maintaining disease-state experts and advocates who can help strengthen brand performance.

You will be responsible for executing marketing and sales strategies that strengthen brand performance and respond to market needs. You will lead in-field execution of key marketing and sales initiatives, coordinate activities related to marketing materials, and support cross-functional in-field processes. In everything you do, you will place patients at the center of your efforts and operate in full alignment with our business code of conduct, policies, and all applicable laws and regulations.
Responsibilities
You will actively engage with multiple stakeholders to gather meaningful market and customer insights.
You will support the execution of marketing-led initiatives, including coordination with partner agencies to deliver effective multi-channel and digital campaigns.
You will share in-field best practices and support in-field teams in tactical execution to ensure alignment and consistency across activities.
You will partner with marketing colleagues in the development of marketing materials and support information gathering for forecasting and KPI monitoring.
You will organize and coordinate symposiums and congresses at national and international levels.
You will capture and communicate changes in market conditions, competitor activity, and other relevant developments to management and the broader team.
You will support digital transformation efforts and help drive in-field implementation.
You will differentiate value proposition with assigned healthcare providers and identify, develop, and maintain disease-state experts and speakers/advocates to help maximize brand performance.

required Medical Advisor Oncology
Purpose:
To provide scientific and clinical support and expertise to drive the Israeli business.
Responsibilities:
Provide scientific and medical support to the Brand Team.
Support and advise the marketing department in the preparation of promotional and training materials.
Review and approve promotional material of products related to the expertise area.
Provide support, advice and training to the sales force and other departments as necessary.
Provide scientific and clinical input into key commercial initiatives as required.
Establish, develop, and maintain strong professional relationships with key external stakeholders including key opinion leaders (KOLs) in the assigned therapeutic areas.
Deliver scientific presentations to KOLs and/or related medical units in the medical centers.
Develop and maintain in-depth knowledge of the companys products, relevant therapeutic areas.
Participate in scientific conferences and meetings related to the therapeutic area.
Provide professional Medical Information to internal and external customers.
Provide support as required to Regulatory Affairs and market access.
Develop medical strategy, planning and implementation of medical activities in accordance with business priorities of GMA and the BT.
Organize and moderate advisory boards, lectures, and scientific/medical events/ education.
Prepare for the launch of new products including preparation of the relevant sections in the file submission to MOH (clinical background, scientific rational, summary of supporting data, local clinical experience).
Clinical Research Activities:
Design and implement clinical research projects within defined standards and budgets (e.g. Phase IV, post marketing clinical activities such as registry/database projects, epidemiological surveys, and PMOS studies).
Provide the required oversight to manage review, approval and conduct of IIS studies.
Support the affiliate Clinical Research Department in the management of clinical studies, as appropriate (e.g. review new clinical study protocols, identifying potential investigators/sites, conducting feasibility surveys).