- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory submissions to FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal ... actions items, risks, and decisions to the team. With direction from management , manages multiple regulatory submission projects, including the development of… more
- Merck & Co. (Durham, NC)
- …shift positions, 12.5 hour rotation (2-2-3). - - The role of Operations Manager at our Company's Durham drug substance manufacturing facility is a manufacturing ... employee development, routine 1:1 meetings and coaching, recognition, and performance management ). Additionally, they must become proficient in the use of… more
- Merck & Co. (Rahway, NJ)
- …(RaDS) value team in our Company's R&D IT brings together product management , engineering, and data science expertise. We enable data, technology and services ... scientists' ability to discover and develop innovative medicines that change the course of human health. In the RaDS...enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position… more
- Repligen (Waltham, MA)
- … Management (user provisioning, privileged access, segregation of duties) Change Management (system updates and configuration changes)IT Operations ... the design and operating effectiveness of ITGCs across Logical Access, Change Management , System Operations, and IT Governance.Conduct IT application… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the team to be effective.Strong track record in executing effective project management in cross-functional teams within IT, clinical, regulatory , pharmaceutical ... 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… more
- Genmab (NJ)
- …a subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications Creates quality control ... regulations/guidance's Creates any needed documentation and training for standard processes, change control management and tools Responsible for defining… more
- Insmed Incorporated (NJ)
- …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 ... of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.Detailed management and oversight of regional trial activities, as… more
- Insmed Incorporated (San Diego, CA)
- …and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews. ... and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory… more
- Genmab (NJ)
- …developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious ... Then we would love to have you join us!The Senior Oncology Account Manager (OAM) for the Pittsburgh territory builds and maintains strong professional relationships… more
- Insmed Incorporated (NJ)
- … management and remain in a validated state (eg SDLC, IT Change Control) per associated SOPs, regulatory and security requirements. \tEnsure compliance ... and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews.What… more
- Lundbeck (Chicago, IL)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... on customer needs and organizational goals, incorporating "total office" account management where applicable. Local Market & Therapeutic Area Expertise - Gather… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Facility Support Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Facility Support Manager is at an exempt level working within the...space walkthroughs to ensure GMP compliance.Actively participate in all regulatory and internal audits of the facility.Participate in the… more
- Merck & Co. (Rahway, NJ)
- …Skills: Adaptability, Adaptability, Business Processes, Business Process Improvements, Change Management , Clinical Research, Cross-Functional Team Leadership, ... , Project Management Information Systems (PMIS), Project Planning, Publications Management , Regulatory Compliance, Risk Management , Sourcing and… more
- Aequor (Thousand Oaks, CA)
- …role will own the execution of the implementation plan in terms of project management and change control execution. This role will apply project management ... across multiple functional areas Assure timely and fully compliant (RFT) maintenance of Change Control Management system related to Global Distribution Change… more
- Merck & Co. (Durham, NC)
- …Maintenance, Automation, and Quality approvers.- As part of the deviation management role, present and defend investigations during regulatory inspections, ... and Skills: Proficient in PI Processbook, Siemens BAS, and DeltaV Project management , including change control and equipment qualification SAP experience related… more
- Aequor (Thousand Oaks, CA)
- …(SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements. ... engaged quality professional with hands-on ownership of quality records, including CAPA and change control. They will be familiar with Veeva or TrackWise systems and… more
- Merck & Co. (Durham, NC)
- … in leading a team-based culture through continuous improvement activities - Assist Manager with facilitating shift change . - Manages training progress of suite ... production and manufacturing operations. -The Lead Technician is a manager developmental role and will serve on the Operations...to support production activities, including batch record events and management of forms and labels on the shop floor.… more
- Cipla (Fall River, MA)
- …- 5:00PM (may vary based on business needs) Reports To : Manufacturing Manager Salary Range: $62,400 - $75,400 Purpose: The content and statements documented in ... of API equipment and products in compliance with site SOPs and regulatory guidance. Autonomously leads and manages projects to implement continuous improvement… more
- Merck & Co. (Durham, NC)
- …transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an ... are guided by policies, procedures and business plan; receives guidance from manager . Contributes to the performance and results of the department. Identifies and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential? ... a self-starter who is self led and keeps their manager up to date on progress and ensures no...and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and builds… more
