- Merck & Co. (North Wales, PA)
- … submissions, as appropriate, and corresponding therapeutic dossiers.Interacting with global regulatory authorities and diagnostic partners to determine ... enable and/or support timely approval of both therapeutic and diagnostic products by regulatory agencies.Representing the Global CDx Regulatory position and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... functional RA strategy into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...medicines. You will lead a global regulatory team to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be an active participant on the Regulatory Operations Leadership Team.ResponsibilitiesManages and develops internal US team members ... areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is...is responsible for the management and oversight of the US Dossier Planning team. The Associate Director … more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... on late-stage pipeline and marketed products, interfaces with cross-functional teams including US medical affairs, marketing, market access global value and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ... the company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg ... plans), including HA engagement plans and mitigation strategies.Ensure high quality collaboration global regulatory leads and provides guidance to the regional… more
- Merck & Co. (Rahway, NJ)
- …pharmaceutical, life sciences and/or healthcare space Understanding and experience with global regulatory requirements for Medical Device and/or AI algorithms ... diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! -...across HH, our Research & Development Division, Medical Affairs, Regulatory , Legal etc. as well as external partners (diagnostic… more
- Merck & Co. (Rahway, NJ)
- …commercial input on such activities as: target product profile development, global regulatory filing strategy, labeling, launch readiness reviews, organized ... Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer...chain: basic science and biology, clinical development and innovation, regulatory processes, global launch dynamics, access and… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... on late-stage pipeline and marketed products, interfaces with cross-functional teams including US medical affairs, marketing, market access global value and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ... the company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and… more
- Merck & Co. (Rahway, NJ)
- …in 2023.We are seeking a leader to take the position of the Associate Director Global Marketing, who will be responsible for maximization of the late ... of post-surgical infections and ensuring successful outcomes. Antibiotics are crucial for global public health.Our Company has a proud legacy of nearly 100 years… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of ... our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development and/or Late Drug Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Merck & Co. (North Wales, PA)
- …commercial activities that interface with internal and external stakeholders, including US Medical Affairs, Regional Vaccine Medical Directors, Global Marketing, ... review processes) including experience including bringing materials through legal, regulatory , and clinical review Strong project management skills as demonstrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include: Clinical summary and overview documents in eCTD format for global regulatory submissions, including investigational medicinal product dossiers (IMPD), ... manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide… more
- Merck & Co. (North Wales, PA)
- …studies.-Under the direction of the Program Lead, you will collaborate with global , cross- functional team-members including clinical directors and study managers to ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... 2023, we became Great Place to Work-certified in the US for the third year in a row. We...and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Program Management, the Associate Director ,… more
