לוח משרות דרושים רפואה ופארמה

In this position, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities:
Actively contribute in the development of regulatory strategies for software and product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities and global strategy for product launch.
Define and prepare document packages for US FDA regulatory submissions, EU MDR Technical Files, and international packages.
Assess product changes and their global regulatory impact.
Ensure timely license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Monitor and document post marketing activities, analysis of trends, vigilance processes.
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post-approval changes

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! We seek a Senior Customer & Account Specialist to promote the company's products. Communicate with HCPs in the Center- HaSharon area ( mainly cardiologists, endocrinologists, Family physicians) The CAS will increase product awareness, answer queries, provide updated and reliable information, and introduce products.

Responsibilities:
Promoting the company's products in the field, based on the BU strategy and work plan. Align and inspire to achieve business goals and KPIs, defined by the BU reporting to the Team Leader. Digital transformation- Engage with customers via multichannel "routes," including face-to-face meetings, online meetings, and phone meetings aligned with Team Leader instructions. Increase interactions via approved emails (AE) and other digital tools provided, routine usage of iPad in F2F meetings, and CLMs. Territory and customers management: MCCP update, Call plan adherence (CPA), and identifying customer needs, using digital tools in Veeva. Territory and customers "mapping"- Mapping HCP’s influencers, periodically, territory sales analysis based on sales reports, and as a result, work planning, aligned with the Team Leader and strategy. Teamwork- share practice, constant reflection, and feedback on field work with team members and the Team Leader.
* Organizing appointments and meetings with specific HCPs.
* Support HCP's decision to optimize patient outcomes in an ethical way.
* Giving lectures to physicians and medical personnel (according to the MC terms).
* Raise awareness of the unit's products and scientific updates (EBM).
* Meeting both the business and scientific needs of healthcare professionals.
* Development of new initiatives, both personal in the territory and at the team level.
* Creating collaborations and establishing professional relationships with HCPs and HFs.
* Active participation in team meetings, including sharing information and best practices, reading relevant materials, and preparing presentations according to the team's needs.
* Open communication with customers and the company’s functions regarding the team's products.
* Maintain a deep and current knowledge of the industry, trade association, competitors, and buyer dynamics, and focus efforts on customer opportunities.
* Working according to the company's practices, compliance codes, rules, and regulatory guidelines.
* Report any safety information received during work to the Pharmacovigilance Department.
* Attending conferences in Israel and overseas.


City:
Petah Tikva