- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're 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 Phase 1-2a,...and performance standards are met by vendors and assigned program staff.Manages global monitoring oversight of site-level activities related… more
- Formation Bio (New York, NY)
- …Lead for clinical assets and associated studies. Step in as the Clinical Project Manager when needs arise. Operational Strategy and Leadership Develop and ... for programs and clinical studies. Collaborate with cross-functional teams ( Clinical Development, Regulatory, Program Management, etc.) to shape and refine… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The RoleThe Senior Manager , Clinical Programming is responsible for the establishment, governance, and integrity of ... Tabulation Model (SDTM) standards that support the scientific need of a study/ program while ensuring quality, consistency and compliance to CDISC standards and other… more
- Insmed Incorporated (NJ)
- …patients with serious diseases. In this role, you'll be reporting to the Sr. Manager , Clinical Supply Chain & Logistics.The Insmed Summer Internship Program ... About the Role:We're looking for a Summer Intern - Clinical Supply Chain & Logistics on the Logistics to...are invested in your growth. The Insmed Summer Internship Program gives students an opportunity to gain hands-on experience… more
- Daiichi Sankyo, Inc. (Denver, CO)
- …centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory ... Manager represents the assigned product, and its approved indications,...hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence… more
- Daiichi Sankyo, Inc. (Philadelphia, PA)
- …areas centered around rare diseases and immune disorders. Summary:The District Manager (DM) represents Daiichi-Sankyo to assigned customers. The DM hires, leads, ... hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking MES Project Manager as part of the Manufacturing Excellence team based in Raritan, NJ.Role ... OverviewThe MES Project Manager will be part of Manufacturing Science and Technology...also be responsible for establishing and reporting on key project/ program metrics in support of on time and on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... We are seeking a highly organized and detail-oriented Business Process Oversight Manager to oversee all aspects of Good Practice (GxP) documentation management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... as appropriate for the area of GxP audits assigned.Responsibilities:Execute the audit program for internal systems as applicable for the area of GxP audits… more
- Insmed Incorporated (NJ)
- …systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical /Manufacturing systems.Project lead experience preferred.Strong experience in Clinical ... and FDA/EU regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental… more
- Aequor (Thousand Oaks, CA)
- Fully Remote - Any TZ Ideal Candidate: Regulated industry experience. Clinical trials experience strongly preferred Nice to have: strong MS Project, MS Word, Visio, ... MS PowerPoint and MS Excel skills ; understanding of systems for sharing and collaboration ; excellent communication skills to work with cross- program resources more
- Insmed Incorporated (San Diego, CA)
- …and resolution guidance. Train, coach, and mentor GxP system owners. Provide CSV program trainings, lunch and learns and guidance to new stakeholders as well as ... responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical /Manufacturing systems.2+ years' in a managerial role with people/project… more
- Novo Nordisk Inc. (Boston, MA)
- …functionally with multiple functions and groups throughout the US organization, Clinical Development, Research & Early Development, other affiliates, and the Global ... a leader in the rare endocrine marketplace. The Rare Endocrine Therapy Manager (RETM) must assume responsibility for achieving sales objectives by implementing… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. The Manager Product training is responsible for the following:- Developing and implementing training programs ... creating, developing, and administering in whole or in part, a training program which includes sales techniques and presentations, product and product applications… more
- Insmed Incorporated (NJ)
- …organization. The role will partner closely with Commercial and Clinical Supply Chain with responsibilities including supplier governance management, understanding ... sourcing projects in areas such as drug substance, drug product, clinical services, and packaging services within a contract manufacturing structureAbility to… more
- Insmed Incorporated (NJ)
- …Quality Assurance, and Regulatory, with input from Commercial, Research, and Clinical .Prepare and manage detailed project plans and drive them to successful ... throughout all stages of product development, including Research, Preclinical, Clinical , Regulatory, Operations, Quality Assurance.Innovative thinking and an entrepreneurial… more
- Novo Nordisk Inc. (Irvine, CA)
- …Sales Representative also assists their target physicians with their local clinical and educational initiatives by coordinating company resources (eg, counterparts, ... the Specialty Field Sales Representative reports to the District Business Manager of the specific sales territory. The Specialty Field Sales Representative… more
- Novo Nordisk Inc. (Holiday, FL)
- …co-promotion partners. Internally, the CMCS I reports to the Portfolio District Business Manager of the specific sales territory. The CMCS I also interacts and ... gain access and drive business impact by collaborating around the clinical management of patients and offering NNI-approved solutions Demonstrates professionalism… more
- Novo Nordisk Inc. (Boston, MA)
- …Internally, the Ecosystem Portfolio Specialist I reports to the Ecosystem Business Manager . The Ecosystem Portfolio Specialist I also must work collaboratively work ... sales volume Utilize discretionary budget for maximum impact on sales Clinical Understanding Deep understanding of cardiometabolic disease state and patient… more
- Insmed Incorporated (NJ)
- …the Role:The Senior Director, Head of US HCP Marketing for our TPIP program in Pulmonary Arterial Hypertension (PAH) will be responsible for shaping and executing ... allied healthcare providers.Partner with Medical Affairs to ensure scientific and clinical insights inform HCP strategies.Identify key insights and translate to… more
