- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year...processes at NN Boulder, specifically in the role of Quality Assurance (QA) subject matter expert (SME).This position is… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.The ... ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.Reviews… more
- Daiichi Sankyo, Inc. (Houston, TX)
- …areas centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager reports to the District Manager and is responsible for ... relationships with the customer and become a resource. Communicate with the District Manager on a regular basis and discuss issues and opportunities. Represent the… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide ... support customer demand (including hiring as needed, employee development, routine 1 : 1 meetings and coaching, recognition, and performance management).… more
- Lundbeck (Chicago, IL)
- …and psychiatry. Join us on our journey of growth! As an Area Sales Manager (ASM) you will be responsible for leading, developing, and managing a diverse, high ... People Achieves business objectives and sales results by observing Account Manager interactions with target customers, extended treatment team members, ancillary… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year...ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for… more
- Aequor (NJ)
- 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial ... required to support global clinical research and development studies during phases 1 -4. The individual must partner closely with clinical, regulatory, quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to become an expert in complex outsourcing models supporting Clinical RD and PH. 1 to PH. IV outsourced services (eg, CRO, Biomarker, CDx, Clinical Supplies, central ... strategy by spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process and procedures.… more
- Aequor (New York, NY)
- …experience of 1 -3 years in case management, utilization review and/or quality assurance Experience in episodic care, wellness care and counseling of adults ... Contractor Position (First 6 months- 5 days onsite, then 4 days/week onsite and 1 day remote) 8:30 AM to 4:30 PM (Monday - Friday) New York Headquarters… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the team has the necessary tools, infrastructure, and support to deliver high- quality AI solutions. Provide mentorship and guidance to individuals and teams on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review ... policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC Lessons… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager , Quality ... of GMP-related experience in a pharmaceutical or biotechnology company with one ( 1 ) year direct Quality Assurance experience Knowledge, Skills, and Abilities:… more
- Insmed Incorporated (Bridgewater, NJ)
- …research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... Colorado facility and works closely with our teams in Lexington, Massachusetts. Ranked the No. 1 Place to Live for the second consecutive year by US News & World… more
- BioAgilytix (Boston, MA)
- …according to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance review of ... technical reviews of documents prior to review by the project manager (eg, Bioanalytical Project Manager (BPM), Principal Investigator)independently creating… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate ... of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, USP, and… more
- EY (New York, NY)
- …VA, MA.The opportunity The FSO Consulting Finance team is looking for a Manager with a strong delivery track record across cost allocations and profitability ... and who will further add to the continued success of our team. As a Manager within our FSO Consulting Finance team, you will specialize in working closely with… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... production goals, while adhering to applicable cGMPs & SOPs. Relationships Shift Manager . Essential Functions Setup, operate, monitor & control equipment, systems &… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements. Support manufacturing investigations, create/revise operational ... forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, provide input on… more
