- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with US FDA and other international bodies.Support the global quality annual objectives, strategic initiatives to deliver against the business plan.In close ... the management representative for all key health authority inspections ( US FDA, EU EMEA, MHRA etc.,).Develop and maintain an...lead as the Head of PV QA with Quality Reviews of respective product profile to ensure appropriate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all ... meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through ... position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages the review of...Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations.The Senior… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... communications deliverables across the Insmed respiratory franchise. This role will lead the development and maintenance of scientific platforms and the strategic… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... Medical Director is a key leadership role and will develop, implement, and lead the portfolio strategy and life cycle management planning across indications. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary This position will lead the valuation processes for in-licensing, out-licensing, co-development and/or acquiring ... model developed in close collaboration with Global Business Development ( US , Japan, EU teams), Finance (Corporate FP&A & R&D),...with our corporate business development strategy. This position may lead a small team and will report to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …labeling and associated documents (including cartons and external packaging in the US ) for assigned Daiichi Sankyo products. This position ensures that draft ... on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either...by managing labeling development or approval for either the US or EU. Preparation of updated Core Data Sheets,… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... Excellence (FME) will develop field medical functional strategy to enable high- quality , impactful customer engagements with a consistent approach worldwide. The FME… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... for being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic… more
- Insmed Incorporated (Bridgewater, NJ)
- …in ensuring a seamless and efficient technology experience for our global workforce. You'll lead a team across the US , Europe, and Japan, providing strong ... 2023, we became Great Place to Work-certified in the US for the third year in a row. We...and we're seeking a skilled and dynamic individual to lead our IT Support Services team. As Director, IT… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Dossier Planning is responsible for the management and oversight of the US Dossier Planning team. The Associate Director provides leadership and oversight to ... create submission plans that result in high quality regulatory submissions and procedures including, but not limited to, original INDs, original and supplemental… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team ... quality , reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …adherence to data privacy requirements. Ensures the company maintains compliance with US data privacy laws and commitments for data handling with affiliates situated ... outside of the US . Managing and advancing the company's data privacy program...research assigned Compliance cases, develop investigative findings, participate and lead investigative interviews, assist with the drafting of Compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes ... defining regulatory data standards, data quality rules and data governance processes across GRA, and...visibility across regions and sub-functionsPartner with the Process Excellence Lead and others to identify process improvements based on… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... responsibilities will include, but not necessarily be limited to, the following: Lead complex clinical trials or indication corresponding to one or several compounds… more
- Merck & Co. (Rahway, NJ)
- …control environment at our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management supervision in addition ... walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in...of duties with the highest level of integrity and quality . Show good judgment in the conduct of work.Work… more
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …continuous learning and personal development. Are you ready to maximize your potential with us ? The Position The Director, CMR Insights Lead is responsible for ... impact. Relationships Reports to the Senior Director, Enterprise Functions Insights Lead with direct management responsibility for developing, leading and managing… more
