- Merck & Co. (Rockville, MD)
- …extramurally to support the company's enterprise policy agenda.Responsibilities of the Director , US Regulatory Policy, will include:Proactively monitoring ... regulatory policy is shaped and developed in the United States .Representing the company in assigned areas...under the supervision of the Executive Director , US Lead, US Regulatory Policy.Participating… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for providing oversight of the preparation, alignment and formulation of strategy for US and/or global regulatory submissions. This position ensures ... Submissions: Provides oversight of the preparation, coordination or monitoring of US and/or global regulatory submissions. Advises on US and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line ... that DS is prepared to meet new or proposed global regulatory requirements and that DS has...collecting, analyzing, synthesizing and communicating intelligence relating to the US regulatory framework. Regulatory PolicyScans… 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)
- …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
- Merck & Co. (Rahway, NJ)
- Job DescriptionCompanion Animal Global Marketing - Director , Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development ... Regulatory , Legal, Manufacturing, Technical Transfer, Supply Planning and Global Customer Marketing and Commercial Execution to ensure optimized and successful… more
- Merck & Co. (Rahway, NJ)
- …engagement execution, target product profile development, health authority interactions, global regulatory filing strategy, organized customer interactions, and ... Job DescriptionWe are currently recruiting for a Director of Global Oncology Marketing to...input on such activities as:target product profile (TPP) development, global regulatory filing strategy, launch readiness reviews,… more
- Merck & Co. (Rahway, NJ)
- …commercialization, including product development team, target product profile development, global regulatory filing strategy, launch readiness reviews, organized ... Job DescriptionWe have an exciting Director opportunity to join our global ... brand team, joint product development team, and joint regulatory / labeling discussionsSupport alliance forecasting and scenario planning by… more
- Merck & Co. (North Wales, PA)
- …, Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and ... with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Global Oncology Communications The role of Director , Global Communications, Oncology is a unique opportunity to join our Company, a ... role will work under the guidance of the Executive Director , Global Oncology Communications in a fast-paced...Global Oncology business strategy while continuously partnering with Global & US Oncology marketing leaders to… 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. (North Wales, PA)
- Job Description Position Description: - Director , United - States ( US ) Hub Programs The Director , Future ( US ) Hub Programs will provide strategic ... input, and manage the development and deployment of Hub programs in the United - States , including programs for Oncology products and future Immunology programs.- … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and CA supply operations including ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, ... RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate...to 10% Occasional travel to Health Authority meetings in US and Europe, potentially Japan.Daiichi Sankyo, Inc. is an… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Engagement (S&PE). In collaboration with NAO Therapeutic Heads, Medical Affairs and global stakeholders, the Director of S&PE will establish the North ... 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
- 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: ... this is your profile, we want to hear from you. JOB SUMMARYThe Director , Clinical Project Management will manage assigned project (s), including program's strategic… more
- Merck & Co. (Rahway, NJ)
- …knowledge of medical device development, design controls and risk managementKnowledge of US and global medical device and healthcare regulations, including FDA ... Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) Team designs, develops, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to our current portfolio and robust ... Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states and DC, with a… more
