- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders to execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance ... around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP...have proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical … more
- Insmed Incorporated (NJ)
- …and teamsProven ability to work within a multi-functional team (legal, regulatory , clinical /medical, quality, research, etc.)Able to multi-task and prioritize ... future of science, we're in. Are you?About the Role:The Senior Manager , Global Medical Information will be primarily responsible for creating/updating/reviewing… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Manager , Programming will provide statistical programming and analytic support clinical ... studies. As a team member of the Programming function, the Manager , Programming will be working interactively with functional colleagues from Biostatistics, … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a Strategic Initiatives & Capacity Expansion Project Manager as part of the Technical Operations team based in Raritan, NJ. ... for strategic initiatives and capacity expansion activities at the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effective project management in cross-functional drug development teams or clinical , regulatory , pharmaceutical sciences/technical operations in the ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , Site PMO as part of the Technical Operations team based in… more
- Insmed Incorporated (NJ)
- …with project goals including Manufacturing, Analytical Development, Quality Assurance, and Regulatory , with input from Commercial, Research, and Clinical .Prepare ... throughout all stages of product development, including Research, Preclinical, Clinical , Regulatory , Operations, Quality Assurance.Innovative thinking and an… more
- Insmed Incorporated (NJ)
- …abilities within the team. In addition, this individual may also take on a leading program manager role for major programs. As a leader, the Executive Director ... and lead activities associated with moving Insmed's late-stage pipeline through clinical development, regulatory submissions and commercial launch. This position… 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 ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (NJ)
- …team members to align and compliantly execute key tactical activitiesCollaborate with Regulatory , Supply Chain, and Clinical colleagues to ensure compliant and ... 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… more
- SolutionHealth (Nashua, NH)
- …a role model and resource, they guide the team and collaborate with the Clinical Nurse Manager to ensure adequate staffing and resources.What You'll Do:Lead ... quality improvement councils.Activate the chain of command for administrative, clinical , and risk concerns.Deliver patient-centered care using evidence-based practices.Utilize… more
- Insmed Incorporated (NJ)
- …from concept to implementation, ensuring that our packaging meets all regulatory requirements, protects product integrity, and enhances user experience. The ... individual will conduct packaging development projects from initiation through clinical and commercial manufacture (launch & beyond). Projects will consist of… more
- Insmed Incorporated (NJ)
- …the Role:The Senior Director, Head of US HCP Marketing for our brensocatib program in HS (hidradenitis suppurativa) will be responsible for shaping and executing the ... HS.Partner with Medical Affairs and Commercial Effectiveness to ensure key clinical and research insights inform HCP strategies.Lead development and implementation… more
- Skaggs Community Hospital Association (Branson, MO)
- …and management experience in the inpatient setting (ie charge nurse, assistant nurse manager ) AND three (3) years of clinical experience Skills * Excellent ... quality efficient care. Provides oversight and management of operational, regulatory , and business processes across nursing services. Excellent communication skills,… more
- Alameda Health System (Alameda, CA)
- …in medical records in compliance with department policy, state and federal regulatory agencies 2. Educates patient, family, other caregivers in management of home ... communicates with referring physicians, support staff, PT Assistants, PTs, department manager as appropriate. 5. Communicates with family, case managers, health… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Program Manager I is responsible for the execution and management of programs that contribute to departmental or cross-departmental objectives. This role ... coordinating timelines, and ensuring effective communication among team members. The Program Manager will work closely with stakeholders to facilitate… more
- Mount Sinai Health System (New York, NY)
- …transitions the protocol to be implemented by investigator(s), program manager (s), clinical research coordinator(s), regulatory coordinator(s), and ... combination of education and applicable experience (preferred: research or regulatory ) + 3 years of experience in clinical...to obtain an IND#. 7. Collaborates with the Financial Manager on the development of the study budget (as… more
- Saratoga Hospital (Saratoga Springs, NY)
- Clinical Regulatory Readiness Manager Location: Saratoga Hospital, 211 Church Street, Saratoga Springs, NY 12866 Employment Type: Full Time Shift/Schedule: ... Regulatory Readiness Manager to ensure regulatory compliance. The Clinical Regulatory ...Credential Stream privilege software. Other functions as determined as regulatory program , NYS immunization reportable for non-employed… more
- J&J Family of Companies (Danvers, MA)
- …Learn more at https://www.jnj.com/medtech **We are searching for the best talent for** a Manager , Medical Writing, Clinical & Regulatory Affairs. This is a ... remote role available in the continental USA. **Purpose:** The Manager , Medical Writing, Clinical & Regulatory...is eligible to participate in the Company's long-term incentive program . Subject to the terms of their respective policies… more
- J&J Family of Companies (Raritan, NJ)
- …at https://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager , Regulatory Program Manager - Oncology. ... Titusville, NJ; Horsham, PA; or Spring House, PA. The Manager , Regulatory Program Manager... Affairs as well as Project Management, Medical Writing, Clinical and other key functions to ensure confidence, quality,… more
