- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Job DescriptionOur Regulatory Affairs team bring new medical...committee charters. (Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product Development Team (PDT), Early… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized ... for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...of the enterprise, especially the transition of rising star early assets to late phase development, based on the… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,)...to deliver on GLP/GCLP commitments that are pivotal to early phase submissions.Collaborate with Global QMS to build a… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs ( Early Development) provides strategic ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical...and procedural cross-functional teams. + Assigns reports to represent early - and late-stage project teams and ensures timely and… more
- Merck (Rahway, NJ)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... **Job Description** Our Regulatory Affairs team bring new medical...committee charters. (Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product Development Team (PDT), Early… more
- Merck (Rahway, NJ)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... someone with a growth mindset. **Position Description:** The Senior Director , Global Regulatory Lead, is responsible for... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …hope for all facing illness. As a senior member of Medical Science, the Senior Director , Medical Science - Early Stage will lead the early -stage development ... therapeutic areas involving complex indications including rare disease/orphan conditions. The Senior Director , Medical Science - Early Stage will be responsible… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and in creating and implementing experimental medicine studies. Reporting into the Senior Director of the Medical Science Early -Stage, the Director , MSES ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… more
- Sanofi Group (Bridgewater, NJ)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing + ... was possible. Ready to get started? **Position Overview** The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area will be responsible… more
- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Director may… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to ... on real-world evidence, and creating hope for all facing illness. The Director , Translational Medicine (TM), will be primarily responsible for creating plans for… more
- Pfizer (New York, NY)
- …CMAO, Medical Affairs Strategy, Biostatistics & Data Management, Global Regulatory Affairs , Clinical Pharmacology / Pharmacometrics, Market Access, Business ... **ROLE SUMMARY** **The Platform:** The Chief Medical Affairs Office's Real World Evidence (RWE) Platform is...expert as assigned with study / analytical KOLs, key regulatory agencies (eg, FDA in the US, EMA in… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, ... documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director , Clinical Development will provide… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …be able to work in a cross-functional setting with the following teams: + Regulatory Affairs + Clinical Development + Biostatistics + Clinical Pharmacology + ... depression in adults as monotherapy and as adjunctive therapy. The Associate Director / Director of Medical Writing provides support for the planning, preparation,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to ... As a senior member of Clinical Operations, the Senior Director , Clinical Operations will lead the full development team...for the company, drawing on expertise in clinical and regulatory requirements, both local and international, related to the… more
