Assist production management in the execution of setup activities to ensure efficient, timely and smooth operations. Set up, operation of and assessing/resolving equipment mechanical problems of all GMP equipment and utilities in the Controlled Classified and non Classified Production/utility areas (A/B, C, D, clean utility area and packaging area) including but not limit

Accountable for functional and technical objectives to support a fill/finish cell and gene therapy technology transfer. Author and review technical documents including, but not limited to technology transfer studies, FMEA, PPQ, CPV, regulatory submissions, and associated reports. Support selected technology transfer projects for the site (primarily for sterile fill/finish

Creation and revision of specifications for current materials/products and new materials/products supporting tech transfer activities and artwork revisions. Create, manage, and/or implement change controls for various activities. Creation or review of quality metrics for monthly Quality Review Board meetings. Ensure metrics are met for items personally responsible for. Kn

Perform method qualification and participate in analytical assay transfer to ensure successful start up of laboratory. Performs compendia method qualifications. Executes analytical and wet chemistry methods using HPLC, FTIR, GC, UV Vis, and other instruments. Execute stability program including pulling, testing and report generation. Perform routine water testing. Monitor

Support and maintains clinical data management processes and data capturing systems for clinical trials by following Ferring SOP Support CRFs development, data mapping specifications, DVP, DMP, and data transfer specifications and tests EDC system functionalities. Participates in cross functional clinical trial teams and communicates data management matters effectively. T

Contribute to and support the company's efforts in communicating the high value of Ferring Uro oncology research initiatives to successfully execute trial needs Initiate and maintain relationships with study investigators to create advocates for Ferring Uro Oncology research Collaborate with the medical affairs team to support current PI involvement and KOL engagement ini

Present healthcare professionals and decision makers with accurate, unbiased, balanced and timely answers to unsolicited request for information about bladder cancer Establish scientific and clinical relationships with key opinion leaders and academic centers to expand research and educational opportunities in Uro Oncology/Bladder Cancer Provide study support from protoco

Collaborate with members of the CLO team and business partners to continuously seek out and lead process improvement initiatives that further the implementation of the CLO Services Model. Identify data within CLO, Ferring, and third party systems and processes that can be used to drive continuous improvement of CLO services. Implement continuous improvement in CLO service

Oversight Lead the overall management of study execution utilizing available performance metrics and quality indicators. Ensure development, management and maintenance of study budget, timeline, and deliverables. Responsible for timely escalation of issues internally to team and management, as appropriate. Financial planning and management. Ensure clear delegation of task

1. Identify optimal clinical data management (CDM) solutions for capturing, integrating, and processing clinical data from different sources (e.g., eCRF, ePRO, eCOA, central laboratory); 2. Provide end to end CDM support by specifying CRF metadata using Trial Definition Tool, EDC functionalities, data validation/transfer specs and CDM plans; by implementing data visualiza

Ensures that all relevant staff and departments are informed of construction and maintenance activities, maintaining clear communication regarding the status of utility shutdowns. Collaborates with the Maintenance Leadership Team, Validation, Quality, and Operations to develop a comprehensive shutdown schedule using Microsoft Project or similar software, enabling thorough

Lead the development and execution of the ADSTILADRIN Patient Strategy and campaign development across appropriate channels, including brand positioning, concept design and messaging. Plan and execute comprehensive marketing campaigns, including advertising, promotions, and events to drive product awareness and consumer demand. Effectively manage Consumer P&L as well as o

Present healthcare professionals and decision makers with accurate, unbiased, balanced and timely answers to unsolicited request for information about bladder cancer Establish scientific and clinical relationships with key opinion leaders and academic centers to expand research and educational opportunities in Uro Oncology/Bladder Cancer Provide study support from protoco

Follows and reinforces the service vision for Ferring. Follows all house rules and safety regulations. Creates a good working relationship with co workers and maintain a courteous attitude towards the guests, management, and all other employees of Ferring. Introduces oneself to the guest while on station and projects a warm cheerful, enthusiastic desire to be of service.

US Regulatory TA Strategy Lead the development and execution of US regulatory strategy in conjunction with Global Regulatory Lead (GRL), Global Regulatory Team and Global project teams. Partner with the GRL to understand the competitive landscape, e.g., views of US HAs, regulatory precedents, labeling differences and TA specific issues. Utilize US regulatory expertise and