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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 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 want to make a difference in people's lives, we invite you to join us! The product manager will be responsible for fully managing the commercial aspects of the product- strategy, budgeting, and business plan, including its execution, and checking if it meets its target. Working closely with overseas partners, having an in-depth understanding of the field, and KOL's. The role combines working in the field, implementing and monitoring unique projects, and working at the office. It also combines managing the field force.

Responsibilities:

* Full ownership of the products, leading them to sales targets
* Collect in-field,cross-functional, and market analysis data and synthesize insights and stakeholders’ behavior and drivers
* Work with a cross-functional team to build a strategic business cross-functional plan based on strategic objectives and define KPIs
* Build a tactical plan including innovative tactics and omni-channel plan to meet strategic objectives
* Execute tactical plan according to KPIs, objectives, and timeline, and monitor it.
* Prepare & execute a budget plan.
* Build and manage a territory plan and monitor it.
* Management of field force, including KPIs setting, planning and monitoring field work, employees development, and recruitment to handle complex field projects.
* Project Management: Identifying and driving critical projects that generate exponential growth
* Develop marketing material for in-field use in collaboration with the partner and according to local regulatory requirements.
* Working with the medical manager to analyze scientific data and present to stakeholders
* Troubleshoot and objection handling.
* Work in accordance with the company code of ethics and guidelines laid down by the regulatory department.
* Work with the internal team to find solutions to get things done in a simplified way.
* Business meetings with overseas partners, training sessions, conferences, etc
* Participation in conferences in Israel and abroad according to strategic priorities.

you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
The Regulatory Affairs Post-Market Specialist leads and executes key post-market activities to ensure compliance with the Israeli Ministry of Health (AMAR) and requirements. This includes managing adverse event (vigilance) reporting, coordinating Field Safety Corrective Actions (FSCAs), and serving as a regulatory contact for post-market issues in Israel. The role involves close collaboration with cross-functional and global teams to maintain the highest standards of quality and patient safety.

Responsibilities may include the following and other duties may be assigned:
Lead the execution and follow-up of Field Safety Corrective Actions (FSCAs) including coordination with internal teams, customers, and submission to the Ministry of Health (MOH)
Manage the adverse event (vigilance) reporting process to the Israeli MOH, ensuring timely and accurate submissions in accordance with local regulatory timelines and guidelines
Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities
Serve as a regulatory contact for the Israeli MOH on all post-market issues, including adverse events, recalls, field actions, and periodic updates
Stay up to date with changes in AMAR regulations, MOH guidelines, and industry standards, and communicate potential impacts to management and relevant teams
Participate in the local recall committee or crisis response team in the event of product safety issues requiring urgent action
Provide training to local teams on vigilance reporting, complaint handling, and FSCA procedures to ensure consistent and compliant practices

We are looking for a Medical writer and Regulatory Affairs associate.
Roles and Responsibilities:
Work with clinical teams and clients to understand the nature of the scientific work that they will be covering.
Assess data or products using medical expertise, and quickly develop expertise in new areas as needed for their writing.
Help to write studies for submissions to the FDA. The writing is also used in publications or medical journals, or for internal company use.
Comprehensive writing of clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
Prepare abstracts, scientific exhibits, posters and verbal presentations.
Help with develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.
Conduct comprehensive literature searches to enhance background understanding, and evaluate and analyze the information which will be written about.
Provide responses to regulatory agencies regarding product information or issues.
Maintain current knowledge of relevant regulations, including proposed and final rules. Help in manage activities such as audits, regulatory agency inspections etc.
Participate in the development or implementation of clinical trial protocols. Preparation and submission of regulatory agency applications, reports, or correspondence.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
Primary function of the position
Clinical scientific knowledge and writing skills to effectively and clearly communicate medical science information in writing. Generally, focus on either scientific medical writing, which includes clinical studies, and regulatory documents, scientific articles or marketing medical writing. Experience in regulatory aspects (RA), help to lead regulatory strategy and provide ongoing regulatory input.

we offer 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! As a QP Pharmacist, you will be Responsible for ensuring compliance with all ongoing control processes designed to guarantee that products are not released to the market until it is determined that their quality matches the approved specifications in the registration file. In addition, responsible for quality processes in the regulatory affairs department that will be adapted to international standards, local regulations, where applicable, and the organizational quality level established for medical products. This is a temporary position for 8 months.
Responsibilities:

* Qualified Person Responsible Pharmacist of the importer.
* Ensuring Compliance with Israeli Regulations: The QP is responsible for ensuring that all pharmaceutical products meet the standards set forth by Israel's Ministry of Health (MoH) and other relevant regulatory authorities. Review the product batch release documentation and authorizing or rejecting the batch release to the market. Certification of Compliance: to certify that each batch of the product has been produced and tested according to relevant specifications and regulations before it reaches the market.
* Accompanying regulatory audits and being responsible for regulatory knowledge, document control, writing procedures, maintaining and updating relevant professional literature, and assisting in planning training activities in the field.
* Liaison with the MOH and working according to the MOH guidelines, including immediate reporting of any complaint or recall if necessary.
* Responsible for batch releases of registered and non-registered products.
* Review PQRs and full batch records provided by the partners.
* Execution of additional supervisors instructions and tasks accordingly.

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!
As a QP Pharmacist, you will be Responsible for ensuring compliance with all ongoing control processes designed to guarantee that products are not released to the market until it is determined that their quality matches the approved specifications in the registration file.

In addition, responsible for quality processes in the regulatory affairs department that will be adapted to international standards, local regulations, where applicable, and the organizational quality level established for medical products.

This is a temporary position for 8 months.
Responsibilities
Qualified Person Responsible Pharmacist of the importer.
Ensuring Compliance with Israeli Regulations: The QP is responsible for ensuring that all pharmaceutical products meet the standards set forth by Israel's Ministry of Health (MoH) and other relevant regulatory authorities. Review the product batch release documentation and authorizing or rejecting the batch release to the market. Certification of Compliance: to certify that each batch of the product has been produced and tested according to relevant specifications and regulations before it reaches the market.
Accompanying regulatory audits and being responsible for regulatory knowledge, document control, writing procedures, maintaining and updating relevant professional literature, and assisting in planning training activities in the field.
Liaison with the MOH and working according to the MOH guidelines, including immediate reporting of any complaint or recall if necessary.
Responsible for batch releases of registered and non-registered products.
Review PQRs and full batch records provided by the partners.
Execution of additional supervisors instructions and tasks accordingly.

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!

We are hiring PV Associate.
Monitoring and reporting adverse events and safety information, ensuring compliance with regulatory safety guidelines and conducting activities to monitor and enhance the safety profile of products
Responsibilities
Receiving, translating, processing and documenting any reports, from overseas or locally, regarding adverse events and safety information of products in compliance with regulatory requirements
Submitting timely and accurately safety reports to the Ministry of Health in compliance with local regulatory requirements
Actively following-up on adverse events reported by physicians and patients
Collecting and reviewing safety and efficacy measures taken by health authorities in recognized countries. This includes monitoring publications, regulatory updates, and safety communications from agencies such as the FDA, EMA, and other global health organizations to ensure compliance and up-to-date safety practices for products
Reviewing relevant data from the scientific literature related to drug safety. This includes conducting literature searches to identify new safety information, adverse events, and emerging safety issues
Promoting awareness among healthcare professionals and medical teams regarding the importance of reporting adverse events to ensure public safety
Conducting periodic internal and external reconciliations
Assisting in preparation for PV audits and inspections
Conducting PV trainings to employees and external suppliers
Additional tasks as defined by the manager