- Insmed Incorporated (San Diego, CA)
- …of science, we're in. Are you?About the Role:We're looking for an Associate Director, Clinical Scientist for the Gene Therapy Clinical Development team to help ... possible for patients with serious diseases. Reporting to the Executive Director, Clinical Development, you will support and work predominately with the Clinical… more
- Insmed Incorporated (NJ)
- …in. Are you?About the Role:The Clinical Trial Manager will be responsible for the management and oversight of phase I-IV clinical trials, with a key focus on ... monitoring oversight of site-level activities related to ongoing and planned trials, management of third-party vendors for clinical services, management … 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
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Associate Director, Clinical Research Scientist will support and work predominately with the Medical Monitor ... and cross functional teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as well… more
- Insmed Incorporated (NJ)
- … Clinical Supply Chain with responsibilities including supplier governance management , understanding market trends, supporting sourcing management process and ... member of the Global Supply Chain & Logistics - Supplier Relationship Management team supporting the Technical Operations organization. The role will partner closely… more
- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role will manage ... while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding that mission.… more
- Insmed Incorporated (NJ)
- …Medical Writer is a REMOTE position, responsible for the development and management of medical writing deliverables, including but are not limited to protocols ... and protocol amendments, Investigator's Brochures (IBs) and IB updates, clinical study reports (CSRs), Clinical Summary Modules for Regulatory Submissions, and… more
- Insmed Incorporated (NJ)
- …change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive ... root cause analysis, investigations, change control, and Quality risk management .Direct experience with clinical manufacturing, analytical method… 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)
- …of Programming strategies and efficient execution of analyses for assigned clinical projects. Collaborates with cross-functional team members within Biometrics, ... Clinical Operations, Regulatory, and Clinical Development, as...in a fast-paced environment Ability to problem-solve Strong project management skills Excellent verbal and written communication skills; able… more
- Insmed Incorporated (NJ)
- …early clinical development through product launch and life cycle management .Ensure HEOR strategies and tactics are cross-functionally aligned and meet the ... across the company including market access, marketing, medical affairs, and clinical development to understand and support Insmed's business needs. This is… more
- Insmed Incorporated (Minneapolis, MN)
- …strong related experience.Other 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. Bring together, synthesize and deliver HCP derived… 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
- Insmed Incorporated (NJ)
- …Are you?About the Role:Reporting to the Director of Technical Operations, Project Management this position will be responsible for leading life-cycle management ... Quality Assurance, and Regulatory, with input from Commercial, Research, and Clinical .Prepare and manage detailed project plans and drive them to successful… 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)
- …and experience . 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
- 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
- Insmed Incorporated (NJ)
- …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.What You'll… more
- Insmed Incorporated (NJ)
- …scientists to investigate therapeutics for treating neutrophil-mediated diseases across several pre- clinical projects. This will involve assisting with tasks such as ... others in fields of personal expertise.Must have strong organization, time management , and keen attention to detail.Strong verbal and written communication skills,… more
- Insmed Incorporated (NJ)
- …The individual will conduct packaging development projects from initiation through clinical and commercial manufacture (launch & beyond). Projects will consist of ... cartons (solid fiberboard)Plastic bottles/Glass vialsFlexible PackagingLabelingPatient KitsThermoformed PackagingExcellent project management skillsHigh interpersonal skills clearly showing strong communication and… more
