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

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

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

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

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 30 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 want to make a difference in people's lives, we invite you to join us! The QPPV is a senior position within the pharmacovigilance team, responsible for ensuring that Medison complies with all regulatory requirements related to the safety of its medicinal products. The QPPV is the primary point of contact for the Israeli MoH and Medison’s global partners and ensures that Medison meets its legal obligations regarding the monitoring, assessment, and reporting of adverse drug reactions

Responsibilities:

* Communicating with the Ministry of Health regarding pharmacovigilance activities, ensuring compliance with local regulations. This includes timely submission of safety reports and responding to inquiries and requests
* Overseeing the internal PV system, ensuring its effectiveness and continuous improvement, including processes, tools, and personnel
* Managing the safety agreements with Medison’s global partners and external suppliers, if applicable
* leading PV audits conducted by Medison’s global partners and inspections conducted by the Ministry of Health
* Communicating with Medison’s global partners, including participation in periodic meetings, as required
* Monitoring the compliance of Medison employees with internal procedures, including corrective actions as needed
* Collaborating with internal departments such as Regulatory Affairs and Medical Affairs to address pharmacovigilance issues
* Ensuring coordination with the Quality Assurance team to ensure pharmacovigilance processes align with company standards
* Additional tasks as defined by the manager

City:
Petah Tikva

our company is an international Medical Device company that develops and manufactures innovative medical equipment. Specifically, we develop infusion pumps and their related accessory products. Job Description: supplier approval/disapproval including supplier maintenance and issuance of the Approved Supplier List. Leading the SCARS process including SCAR initiation, SCAR follow up, Supplier investigation approval including root cause analysis and SCAR closure. Leading the supplier audits process (including initial and surveillance audits) for critical suppliers, service centers, laboratories etc. by conducting on site / remote audits. Issuance and execution of the supplier audits plan including supplier audits follow up and supplier non-conformance follow up and response approval.
* Support the execution of service agreements, quality agreements with suppliers and service centers. Leading the supplier score card process, including trending.
* Serve as  CAPA Coordinator and Subject Matter Expert
* Responsible and accountable for CAPA ownership, timely execution, and effectiveness of CAPAs. This includes creation, collaboration with functional teams on Problem Statement writing/Scope identification/Risk Assessment/Containment/Correction/CAPA plans/Verification of local and global compliance to CAPA procedures to ensure timely effective closure of CAPAs Generate data and key quality trending information for use in periodic reviews like Quality Metric Reviews and Management Review for CAPA and supplier processes.
* Work within, and ensure adherence to Quality system procedures, work instructions and other Quality system requirements.
* Write, update, release, and sign quality documentation within the Quality management system
Direct manager: QA Compliance Manager