לוח משרות דרושים רפואה ופארמה במרכז

We are currently seeking a Medical Lead (all genders), to be based in our local country organization in Petach Tikva.
ROLE OBJECTIVE

Provide medical expertise for Therapeutic Area(s)/ products of responsibility to internal stakeholders (Marketing & Sales, Market access, BD)
Collaborate with cross-functional teams to ensure effective product life cycle management, from launch strategies to lifecycle planning.
Support the LOC Medical Director in establishing the local Medical Strategy Plan and its implementation for the TA of responsibility
Support the LOC Medical Director in facilitating smooth operations in the Medical department: audit readiness, budget oversight, L&D, systems integration, design, and tracking of KPIs
Ensure the correct interpretation and communication of scientific data of products
Advocacy for patients needs and safety
Lead and manage medical advisors/MSLs in GI and NPP according to medical plan.
ACCOUNTABILITIES

Medical/Scientific Affairs

Leading the development and implementation of the Strategic Medical Plan to maximize medical performance
The successful achievement of tactical objectives and milestones outlined within the Strategic medical plan
Strong understanding of the local market and close monitoring of environmental changes and competitor activities in order to be able to fine tune planned tactics;
Directing generation and analysis of data to seek out opportunities to support recommendations for strategic direction based on demand and market dynamics;
Continuously screen, review and analyse scientific literature; generate summaries & critical assessments if appropriate
Present the clinical evidence to internal and external stakeholders in a non-promotional way
Assess scientific accuracy and validity of non-promotion material and its compliance with standards, SOPs, and national laws
Communicate and align with Regional and Global Medical Affairs functions
Develop local strategic medical plans in line with product Life Cycle Management plans and oversee execution (including the production of local publications, planning, and conduct of local Advisory Board meetings etc.)
Establish and maintain strong relationships with Key Opinion Leaders (KOLs)
Act as communication link to authors of scientific publications about products
Provide extensive, clear and structured briefing to external presenters/speakers sponsored medical events, e.g. local Advisory Boards, doctors meetings
Identify gaps in the local clinical study program which are a hurdle for successful regulatory and/or clinical acceptance of the product and propose studies to address these issues
Provide medical expertise to LOC Regulatory Affairs/LOC Pharmacovigilance/LOC Quality Assurance/LOC Market Access
Evaluate and support local investigator initiated research proposals in alignment with global strategy and standards and SOPs
Budget responsibility for medical affairs activities related to TA/product
Other medical and scientific support duties as assigned
Provide medical training for allocated therapeutic area / products to

we are looking for a Quality Compliance Manager
Essential Duties and Responsibilities:



Exhibit a strong quality first mentality and ensure that QMS processes are held to the highest standard, Support the sites continuous quality improvement projects.
Lead QA Specialists/Engineers in the day-to-day activities- supervise and monitor over the employees performance and tasks handling, training, and objectives according to the organizational goals.
Work cross-functionally with other team managers and project teams leaders to provide QA guidance and ensure success of projects and support other QA dept activities- second approval of batch release and graphics, CAPA/Corrections, quality agreements.
Lead Quality Management System compliance (EN ISO/ISO 13485 and MDSAP) and Quality System activities related to regulatory requirements (such as MDR 2017/745, MDSAP, etc.).
Lead QA Specialists/Engineers who are responsible for customer complaints handling- investigation, root cause analysis, Risk Based Approach, applicable corrections/corrective actions, Returned Material Authorization (RMA) and Returned Goods Authorization (RGA) handling.
Lead QA Specialists/Engineers who are- responsible for the sites complaints trending, support RA in identifying Adverse Events/Hazardous situations and provide inputs into the applicable product and process risk management (dFMEA/pFMEA).
Lead QA Specialists/Engineers who are- responsible for the sites supplier quality management, audits, Quality agreements, SCARs, point of contact to customer/third party related matters/ inquiries/ questionnaires, Perform supplier/subcontractor and internal audits.
Lead the sites external audit program- verifying the readiness of all applicable personnel and processes, execute CDAs with the auditing party, perform preparations meetings with functional managers/team leaders/personnel. Execute External audits by any third party, customer, applicable regulatory authorities, and Notified Body, while working within a multi-functional team environment for medical devices. Perform routine follow ups on External audits status, issue Corrections/Corrective actions and communicate responses to third party, customer, applicable regulatory authorities, and Notified Body.
Lead the sites quality system procedures maintenance by verifying their compliance to relevant regulatory requirements, and their alignment with applicable west Enterprise procedures.
Leading the site preparations of periodical management reviews.
Lead the risk management policy file maintenance activities.