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

Account Management Achieves predetermined sales goals according to company and department requirements. Engages in promotional activity with hospital, outpatient centers, solution based system influencers, and large gastroenterology group practices for product adoption. Identifies which individuals within the geography that have the greatest impact on decision making and

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

Passive Candidate Sourcing Drive passive sourcing using a variety of tools and techniques to identify top quality talent for our various job openings. These will include online job boards, LinkedIn, Google, Boolean Searche s, X Ray searches , database mining, silver medalist strategies and building referral networks. Candidate Assessment Conduct screening interviews and a

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

Responsible for PV Safety function for all Ferring Investigational and approved products. Responsible for Adverse Event and Medical Device Reporting for all Ferring Investigational and approved products. Serve as Deputy Local Safety Officer responsible for Pharmacovigilance safety function in the US. Responsible for management of safety case reporting Provide Pharmacovigi

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

Account Management Achieves predetermined sales goals according to company and department requirements. Engages in promotional activity with hospital, outpatient centers, solution based system influencers, and large gastroenterology group practices for product adoption. Identifies which individuals within the geography that have the greatest impact on decision making and

Manage Regulatory Affairs, Advertising & Promotion and Compliance Group Manage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motivate line reports to achieve shared and individual goals. Regulatory Leadership of Advertising and Promotional Materials Serve as subject matter

Partner with Market Access and Finance teams to understand and map current models, processes, and data structures. Lead the business requirements gathering during the explore and discovery phases. When necessary, you write design decisions, driving cross team alignment. Mediate the information exchange between program team and business stakeholders to ensure that each req

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

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

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

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