- Insmed Incorporated (San Diego, CA)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Program Management , the Associate Director , ... in special department, cross-functional, or team projects. The Associate Director of Program Management will...Project/ Program Management experience with proven management and/or leadership experience in an R&D, Regulatory… more
- Merck & Co. (Durham, NC)
- …VMF Maintenance, Weigh and Dispense, Hilleman Clean Utilities, Site Facilities. Emergency Management program and Facilities Maintenance. Teams with GES, site ... safe work environment with optimized product quality and manufacturing processes and regulatory compliance.Lead the Facilities Maintenance and IFM program for… more
- Novo Nordisk Inc. (Dallas, TX)
- …throughout the US affiliate and globally if needed; responsible for administrative and management support of field-based FMA Program at Novo Nordisk Inc (NNI). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...all laws, regulations and policies. Responsible for administrative and management support of field-based FMA Program at… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Safety & Environment - Animal Health Seeking a dynamic, self-directed, Environmental Health & Safety ... (EHS)-professional with manufacturing experience and strong management and leadership skills. As part of Global Safety and the Environment (GSE), the successful… more
- Insmed Incorporated (San Diego, CA)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead ... & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.… more
- Merck & Co. (North Wales, PA)
- Job DescriptionWe are currently recruiting for an Associate Director US Oncology Consumer Marketing to work on our future launch strategy for the subcutaneous ... current and future business opportunities. The position will report to a Director , US Consumer Marketing.-The Associate Director role requires outstanding… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and inspection preparedness for the respective PV inspections in alignment with regulatory and company strategy.Act as the management representative for all ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the...impacting products from a quality perspective. Provide updates to management on MTP strategy for PV QA area and… more
- Tris Pharma (Monmouth Junction, NJ)
- …the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. The Executive/Senior Medical Director ... to Pain programs and assists, as appropriate, in other therapeutic area program development (ie, substance use disorders, ADHD, etc.); Designs and implements… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...and shaping scientific strategy both at the platform and program level.Project management and/or scientific over-sight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This Clinical Science (CS) Group ... Lead will be responsible for overseeing multiple program -level CS Asset Leads who are managing a team...with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and other RD functions… more
- Merck & Co. (Millsboro, DE)
- … inspections (USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for animal welfare, management of… more
- Merck & Co. (Rahway, NJ)
- …social complexities and integrate to project plans.-Experience in Relationship Management , Operations, Technology Transfers, Regulatory , Procurement, Capital ... Job DescriptionJob Description Director , Project ManagementManufacturing Strategy, Business Development and Alliances Overview :Manufacturing Strategy, Business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in ... creation of developmental and regulatory strategy; Drafts protocol profiles and sections of key...trial, clinical trial plan and contingency planning, Analyzes, updates management on potential risks to study deliverables, provides input… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program safety reporting (eg, Periodic ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and enhancing globalization at DS QA-GMP affiliates. Proactively supports Global QA CMO Management and Global QA Audit Program teams.Responsible to ensure that ... and collaboration with Global External Supplier QA teams.Collaborate with Global Quality Management System (QMS) teams on regulatory -related CAPAs that impact… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Global Commercial Program Head as part of the Technical Operations team based in Somerset, New ... is a key member in the global MSAT organization. This individual will be a program lead / owner for a best-in-class high volume marketed CAR-T product as part of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management , CMC and Regulatory Affairs teams. ... with the VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management , CMC and Regulatory Affairs teams… more
