לוח משרות דרושים רוקחות ופארמה במרכז

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

R39882

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.