- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers responsible for Medical Assessment of ... reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and advisor...within Patient Safety organization, CMR, outside of CMR, and Global Patient Safety and Safety Surveillance teams. Works closely… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... corrugated,)Execute projects encompassing primary through tertiary packaging development including labeling and combination product kitsGeneration/Review and approval of test… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) driving...+ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) providing...+ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead… more
- Sanofi Group (Morristown, NJ)
- …setting clear expectations for the device regulatory strategy, including a global labeling strategy + Ensures alignment and communication internally and ... **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** :...teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices … more
- AbbVie (North Chicago, IL)
- …Review Safety Data Information for Instructions for Use (IFU) to ensure accurate device labeling New Product ( Device , Combo, IVD) Development Participates ... other AbbVie office locations in the US. Purpose: Medical Device Safety Physician leads the safety oversight relevant to...on a contemporaneous basis. + Provide medical leadership on global teams on safety related issues. + Responsible for… more
- Lilly (Indianapolis, IN)
- … Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA- Devices , GRA-RD&E, and GRA- Global Labeling and Product Communications. ... a global regulatory strategy which supports product (including delivery device and relevant medical devices ) development, registration, and lifecycle… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). We are an innovative global...and updating of standards and processes related to drug, device , and biologics US AdPromo regulations and guidances. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the Device Engineering, Primary Container, Process Development, Packaging, and Labeling functions, and work closely with Strategy & Operations, Human Factors, ... aspirations. Join Gilead and help create possible, together. **Job Description** The Director , New Product Planning & Drug Delivery Innovation, will serve an… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …regulatory submission content (510(k), Technical Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and ... Summary** **Job Description** BD is one of the largest global medical technology companies in the world and is...self. Become a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to the Senior… more
- Candela Corporation (Marlborough, MA)
- …MA** State/Territory **Massachusetts** **Company Overview:** Candela Corporation is a leading global aesthetic device company with a comprehensive product ... personal relationships even in heated or difficult/dynamic circumstances. . Global accountability for Design/Supplier Quality performance, Sterilization/ Labeling … more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- …Skills + Excellent communication skills including: verbal, reading and writing. + Use various labeling software tools such as TVT and/or Global Vision. Can be ... Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood...conversion to OTC or OTC Monograph direct including any labeling reviews and updates. + Ensure all manufacturing, packaging,… more
- Amgen (Cambridge, MA)
- …processing and manufacturing of injectable drugs in vials, syringes, cartridges, devices , disposables, and the associated GMP/ Device documentation and regulatory ... Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management** **What you will do** Let's… more
- Roche (Indianapolis, IN)
- …medical affairs, legal, and other business stakeholders. The Regulatory Compliance Director may contribute to global cross-functional or cross-chapter squads, ... every voice matters. **The Position** **The Opportunity** The Regulatory Compliance Director is a people leader role. Primary responsibilities include leading a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the lives of patients with life-threatening illnesses worldwide. We are seeking a Director , Quality Site Lead located in Foster City, CA. **Job Functions:** + ... validation, and release/disposition. + Partner with internal stakeholders such as Global External Manufacturing, Global Supply Chain, Pharmaceutical Development,… more
- Sanofi Group (Morristown, NJ)
- …relationships with FDA are established and maintained. + Provides input into the global organization for labeling strategies of marketed drugs. + Demonstrates ... **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- Hologic (San Diego, CA)
- Director , Hardware and Systems Engineering (R&D) San Diego,...you a visionary R&D leader ready to make a global impact in diagnostics? Do you thrive on driving ... to join our mission! **About the Role:** As our Director , Hardware and Systems Engineering, you will lead our...a proven level of technical expertise, ideally within Medical Device and Diagnostics space, and a successful cross-functional leader… more
- J&J Family of Companies (Raritan, NJ)
- …the way. Learn more at https://www.jnj.com/innovative-medicine **POSITION SUMMARY:** The Director , Study Responsible Physician (SRP) is responsible for development ... clinical/medical issues + Assists Regulatory Affairs in the development of drug/ device regulatory strategies + May act as company spokesperson regarding publication… more
- Takeda Pharmaceuticals (Boston, MA)
- …well as other labeling documents. + Demonstrate knowledge of local and global health authority requirements. + Support GPSE in the maintenance of a highly ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
- ASM Global (Laredo, TX)
- POSITION: Part-Time Maintenance Technician DEPARTMENT: Operations REPORTS TO: Director of Operations Summary ASM Global , the leader in privately managed public ... preventative maintenance on electrical equipment, motors, controllers, and electro/mechanical devices . + Respond to building service calls; assist Maintenance… more
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