Function efficiently & independently in dynamic environment Strong team player and communication skills required with an ability to interact with individuals and teams at all levels across the organization and the global network. Strong working knowledge of statistics will be highly regarded. Business travel to other Ferring sites up to 30%. Location The position will be

Independently provide compliance guidance on promotional and non promotional materials, scientific exchange, disease state, medical/scientific programs and R&D activities to minimize company risk and facilitate compliance that is in alignment with applicable regulations. Develop and execute an engagement and integration plan in symphony with other Compliance Associate Dir

Assembles data for Quality Review Board (QRB) reporting and monitoring for local GXP compliance to established metrics. Ensures adequate actions are taken in response to quality issues through follow up.Identifies areas for improvement and modifies QRB process, where necessary. Perform audits primarily focusing on clinical development activities and potentially patient sa

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

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

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

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

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

US Regulatory TA Strategy Develop and execute US regulatory strategy, with oversight as needed, and 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

Manages all BU and brand needs from a SFE perspective in supporting sales teams (5), Market Access/Trade, KAS (1) KAMs (2) and MSLs Develop a strong understanding of sales strategies including sales force effectiveness initiatives, customer segmentations, affiliations/alignments, engagement activities and surface insights to key stakeholders Mentor and onboard new users o

Lead and manage multiple commissioning / qualification / validation activities performed at facility with minimal supervision. Equipment Qualification / Re Qualification (IQ, OQ, PQ) for process equipment, QC equipment, packaging equipment, clean utilities. Cleaning Verification / Validation studies for transferred products. Media Fills / process simulations protocols. En