Operational product designer állások, munkák egészségügy, gyógyszeripar területen

Once agreed upon with CSO Project Team actors (3-6months ahead of M2), the OPCM CSO is the single accountable person for the accuracy of the entered plan and regular updates in the planning tool (Planisware solution). The OPCM CSO ensures that the clinical operational plan reflects the project...

For each assigned therapeutic project (synthetic or biologic molecule) and once agreed with the CMC Project Team actors, the CMC OPCM is the single accountable person for the accuracy of the entered plan and regularly updated in the planning tool (Planisware solution). The CMC OPCM ensures that the...

• Execution of validation and testing activities according to quality requirements
• Validation and qualification of manufacturing and testing equipment
• Supporting the preparation of validation protocols, reports, and maintenance procedures
• Identifying and documenting potential process or equipment gaps

• Support planning, tracking, and assembling regulatory content for simple submissions
• Manage operational tasks such as document retrieval, submission creation, and delivery
• Coordinate with global teams to maintain timelines and compliance

• Lead our M&S operations & teams located in both Budapest & Barcelona Hubs
• Work in collaboration with M&S Global leadership, functions for Quality, Quality Control, Supply Chain, MSAT, HSE, Engineering, GDPU etc., subject matter experts and other hub location teams.

• Literature reviews as requested by client epidemiologists using the best practice methodologies
• Literature search and preparation of Literature review report for Pharmacoepidemiology
• Perform peer Scientific & Technical Review

• Operational management of the company’s quality assurance system as the Qualified Person (Responsible Person).
• Supervision of quality assurance processes at partner companies and within the group’s sites.

• Responsible for the functionality, data quality, compliance, and user-friendliness of RIMS and eCTD systems.
• Ensuring the operation, maintenance and further development of the systems (Extedo eCTDmanager, Veeva RIM).

Work closely with CTCO Process Owners in order to ensure that any established processes adhere to AZ global quality standards....

• Oversee work for timely completion of a complaint investigation and response to the various customers
• Communicate with customers regarding complaints, product issues and returned devices

• Vendor selection and quali­fication
• Clinical budget nego­tiation and vendor contracting on behalf of the sponsor
• Vendor oversight and performance management
• Clinical trial risk assessment
• Management and over­sight of CROs and other external vendors to ensure success­ful trial conduct

• Regional accountability for overseeing and enhancing eQMS system processes to ensure operational efficiency and transparency
• Drive standardization of the assigned system processes – both in the area of GMP and GDP
• Collaborate closely with the regional Business Process Owner

Lead the evolution of the KAM team into a high-performance organization through clear vision, empowerment, coaching excellence, and a culture of continuous learning and improvement, by consistently applying and exemplifying Jazz’s high-performance practices....

Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects...

End-to-End Project Management: Lead CMC development programs from initiation to execution, maintaining operational and financial control through detailed plans, timelines, budgets, milestones, dashboards, and forecasts....

Development of product strategies for existing and new portfolios, including market research to identify innovation opportunities in lens technology and design, as well as defining product specifications and managing the product lifecycle...

• Lead and manage client relationships for pharma and biotech accounts, ensuring satisfaction and longterm partnerships
• Serve as product owner or strategic advisor on key market access projects (AMNOG, EU HTA, pricing, reimbursement)

Design and execute strategic, customer-centric initiatives, including high-profile Investigator Meetings and site engagement activities, to align with our global development goals....

• Strong leadership to guide the medical team and influence cross-functional collaboration.
• Strategic vision paired with operational agility to deliver in a dynamic, fast-paced environment.

• Leading and advancing chromatographic methods for the characterization of active ingredients, pharmaceuticals, and excipients
• Ensuring robust analytical results with a focus on content determination, degradation products, stability profiles and degradation pathways