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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 to benefit the patients we serve. We are a dynamic, fast-paced company operating in over 34 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 Customer & Account Specialist’s job is to promote our company's products. Communicate with professional HCPs (physicians, nurses, pharmacists). The Customer & Account Specialist will increase product awareness, answer queries, provide updated and reliable information, and introduce new products.

Responsibilities:

* Territory and customer management: MCCP update, Call plan adherence (CPA) and identifying customer needs, use of digital tools.
* Organizing and conducting meetings with HCPs in the designated work territory, ensuring compliance with specified requirements and the assigned action plan.
* Providing support to HCPs in optimizing patient outcomes
* Delivering lectures to HCPs (according to the MC terms).
* Professionally promoting the company's products and providing scientific updates based on evidence-based medicine (EBM).
* Developing new initiatives.
* Establishing collaborations and fostering professional relationships with HCPs.
* Actively participating in team meetings, including sharing information and best practices, reviewing relevant materials, and preparing presentations and marketing materials as per the team's requirements.
* Taking an active role in team/unit projects.
* Maintaining open communication with other functions within the company regarding the team's products.
* Attending conferences in Israel and overseas.


City:
Petah Tikva

We are seeking a detail-oriented Product Environmental Compliance Specialist to ensure our company's adherenceto applicable environmental, materials and product compliance regulations. The ideal candidate will have a strong understanding of environmental compliance requirements and the ability to interpret, implement, and monitor regulatory obligations throughout the product lifecycle.
How your job will look like?
Stay up to date with evolving global regulatory requirements and industry standards, ensuring compliance across all relevant areas.
Manage and maintain compliance systems and tools (e.g., Silicon Expert, Agile, and similar platforms), ensuring accurate regulatory data, reporting, and support for compliance processes.
Monitor and interpret changes in environmental and product compliance regulations and standards (e.g., RoHS, REACH, ELV), assess their impact, and coordinate implementation of required actions.
Collaborate with product, engineering and development groups to conduct thorough risk-assessments, identify potential compliance risks and develop effective mitigation strategies.
Develop and maintain compliance policies and procedures, to ensure requirements are integrated into product design and development processes.
Obtain, review, and maintain required compliance documentation, certifications, and regulatory declarations.
Train staff in compliance with requirements and best practices.

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.