- 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …within the Inflammation TA. You will work closely with the Inflammation Fibrosis Regulatory Affairs (RA) Franchise Lead, Regional Regulatory Liaisons and ... be accountable for the development and execution of global regulatory strategies for early and late-stage assets...regulatory strategy. + Provide strategic guidance as the Regulatory Affairs Inflammation subject matter expert on… 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
- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …with leadership within Biostatistics and Data Management, Clinical Sciences, Regulatory Affairs , Development Operations and Development Program Management, ... The Executive Director , Biostatistics (CDU-Biostatistics Head, Internal Medicine) leads the...the development programs within the CDU, from pre-IPA through regulatory approval and post-marketing, and builds and empowers teams… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …PK analysis plans, study reports, and Clinical Pharmacology sections of regulatory submissions. The Senior Director , Clinical Pharmacology also analyzes, ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… 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
- 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
- Merck (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… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Platform: The Chief Medical Affairs Office's Real World Evidence (RWE) Platform is responsible for establishing global scientific leadership and ... markets into one team to drive efficiency through internalized work. The Sr. Director , Internal Medicine Migraine RWE Scientific Lead plays a critical role in the… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation ... visible expert leader, he/she will engage the clinical, Medical Affairs and commercial organization and drive the product evidence...an effective use of HEOR and RWE methods. The Director will provide HEOR and RWE strategic direction to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements. + Supports Regulatory Affairs in providing quality content and review of documents ... 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… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …leaders, advisory boards, patient advocacy groups), internal stakeholders (eg, Research, Early Clinical Development, Medical Affairs , Marketing, HE&OR), and ... The Senior Medical Director , Clinical Sciences, Hematology provides clinical leadership and is responsible for all clinical deliverables within the assigned section… more