- Insmed Incorporated (NJ)
- … management , GCP, etc.Develops operational strategies for implementation of clinical studies regionally/globally in conjunction with project teams and other cross ... rare disease and/or orphan indications is preferred.Knowledgeable in all aspects of clinical operations, project management , the drug development process, and … more
- Insmed Incorporated (San Diego, CA)
- …(SOPs).What You'll Do: Participate in cross functional teams to develop and implement clinical studies within clinical program (s). Collaborate with internal ... in. Are you?About the Role:We're looking for a Director, Clinical Scientist for the Gene Therapy Clinical ...safety, and quality assurance teams, as well as overall program support ensuring adherence to all standard operating procedures… more
- Insmed Incorporated (NJ)
- …industry. Additionally, you have: Experience across multiple phases of clinical research (Phase 1-3).Significant management experience in ophthalmology ... you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand what's possible for patients with serious… more
- Insmed Incorporated (NJ)
- …the Sr. Manager, Clinical Supply Chain & Logistics.The Insmed Summer Internship Program is designed to give you more than just a glimpse into the pharmaceutical ... startup processes such as demand forecasting, regulatory submissions, and vendor/contract management .Coordinate with the Clinical Supply Chain Team to create… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning and ... developing and executing strategic plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for … more
- Merck & Co. (Rahway, NJ)
- …the network. Incorporate relevant digital tools to automate and improve project/ program management efficiency where relevant.Cross-Functional Team Leadership: in ... DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical...with sub-team and use- case leads to track use- case metrics and rollup into program KPIs.… more
- Insmed Incorporated (NJ)
- …are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program . This role will ... cloud security, and identity management .Skilled in budget planning, vendor management , and strategic program delivery .Proven track record of driving… more
- Insmed Incorporated (NJ)
- …Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for safety ... products. Additionally, you'll have:5+ years of demonstrated experience with medical case reviews, aggregate reporting, safety surveillance, signal management ,… more
- Insmed Incorporated (NJ)
- …Relationship Management , you'll partner closely with Commercial and Clinical Supply Chain with responsibilities including supplier governance management , ... in. Are you?About the Role:We're looking for a Senior Manager, Supplier Relationship Management on the Global Supply Chain & Logistics - Supplier Relationship … more
- Insmed Incorporated (NJ)
- … studies. You will be working interactively with functional colleagues from Biostatistics, Clinical Operations, Data Management and Project Management , as ... Do: In this role, you'll be responsible for:Provide programming support to clinical studies and submissionsCreation of CDISC compliant SDTM and ADaM datasets using… more
- Insmed Incorporated (St. Louis, MO)
- …and infectious diseaseOther Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management /trial experience and 2 years clinical ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Collect, synthesize and deliver HCP derived scientific… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... and serves as the leading expert in quality, compliance, and quality management systems (QMS). Provide direction & coordinate the Quality organization activities to… more
- Insmed Incorporated (NJ)
- …Sets tasks, prioritization, and resources within assigned compound(s) Provides program -level programming leadership and support to clinical development ... of Programming strategies and efficient execution of analyses for assigned clinical projects. Collaborates with cross-functional team members within Biometrics, … more
- Insmed Incorporated (NJ)
- …for assigned projects including project timeline planning and documentation workflow management for global regulatory documents (including but not limited to ... and act as a point of contact for cross-functional teams (eg, Clinical , Nonclinical, CMC) to ensure effective coordination and execution of regulatory deliverables… more
- Insmed Incorporated (NJ)
- …Executive Director, Regulatory Operations, you'll be responsible for the publishing, management , and submission of regulatory documents in accordance with global ... The role has a strong focus on eCTD publishing and document management within Veeva Submissions Vault, ensuring accuracy, compliance, and timely delivery of… more
- Insmed Incorporated (NJ)
- …guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (eg SDLC, IT Change Control) ... and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews.What You'll… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …license agreements, and amendments. The role will be utilizing Procurement's Contract Lifecycle Management (CLM) platform on a daily basis and will be at the ... role will execute specific Procurement processes such as MSA expiration management , Coupa-TPR look-up, etc. Relationships Reports to the Senior Director, Procurement… more
- Insmed Incorporated (San Diego, CA)
- …and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory and ... and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews. \tOnsite at… more
- Merck & Co. (Durham, NC)
- …audiometry and spirometry, monitoring compliance, and assessing outcomes of testing. Case management of work-related injuries in collaboration with Nurse ... required.-ACLS certification preferred. #MSJR Required Skills: Collaborative Communications, EHS Program Management , Electronic Medical Records (EMR), Health… more
- Insmed Incorporated (NJ)
- …You'll Do: Lead development and execution of global regulatory strategies for clinical , pre- clinical , and lifecycle management activities for assigned ... the planning and coordination of global regulatory submissions, including clinical trial applications for multinational trials, core briefing packages, and… more
