- Novo Nordisk Inc. (Boulder, CO)
- …support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at ... About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as… more
- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business. The Program Clinical Supplies Project Manager serves as the primary program-level Global Clinical Supply point of ... development related meetings.- Working independently, the Program Clinical Supplies Project Manager designs strategic and operational plans for all clinical supply… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in ... project management in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/ technical operations in the biopharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... supplies . Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Maintenance/Calibration Manager is a leadership opportunity within the Engineering/Maintenance team supporting a new drug substance manufacturing ... operation.- The individual in this role must provide direction, coaching, and technical expertise to maintenance and instrumentation technicians assigned to start up… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the ... process improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and Inspections, and is the IT… more
- Merck & Co. (Durham, NC)
- …with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract ... aligned with strategic direction defined by the global business model and regulatory agencies.- The role will require working with Operations, Technology, Supply… more
- Genmab (Plainsboro, NJ)
- …role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams (and others) and ... development (POD) teams in the security of processes related to (web) application development, Infrastructure as Code, and other PODs that have a code… more
- Merck & Co. (Rahway, NJ)
- …Research and Development (B-AR&D) is responsible for providing strategic and technical leadership for analytical development of candidates from the discovery ... Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our… more
- Novo Nordisk Inc. (Durham, NC)
- …following activities: People Focus, Equipment Focus & Standards "Gatekeeper". Relationships Manager , Technical Support - OFP Essential Functions Work primarily ... us make what matters. The Position Seeking level II or Sr level Application Engineers with Pas-X experience. This position is responsible for ensuring reliable &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure cohesive and comprehensive service delivery. The lead will provide technical leadership, guiding the team in the adoption of innovative technologies and ... ensuring alignment with global and regional business objectives. Provide technical leadership across all non-regulated system implementation projects, guiding the… more
- Merck & Co. (North Wales, PA)
- …this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a global, cross-functional team.Job ... study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment… more
- Merck & Co. (Durham, NC)
- …by policies, procedures and business plan; receives limited guidance from manager .Provides planning and scheduling guidance to mechanics, technicians and colleagues ... management skillsExperience scheduling maintenance, production or similar activitiesFamiliarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral… more
- Merck & Co. (North Wales, PA)
- …support our Company's Purchase Based Contracting customers and will require robust technical skills and business acumen. The highest level of compliance with ... contract terms and conditions, regulatory requirements, and laws is required, while also striving...of COGNOS and SQLFamiliarity with Microsoft AccessIn accordance with " Manager 's Policy" - Job Posting and Employee Placement, all… more
- Nestle (St. Louis, MO)
- …the power of togetherness-We are Proudly Connected. Purely Driven. **Position Summary** The Technical Application Manager ( Regulatory ) is responsible for ... overseeing and coordinating our product development review program and standards with a team of experienced professionals while aligning with the strategic initiatives that impact the development and formulation of pet food and pet supplement products. This… more
- Amazon (New York, NY)
- Description We are looking for a highly motivated Technical Program Manager to join our regulatory operations team. As part of the team, you will own the ... to effectively track, manage and respond to our global regulatory and compliance obligations at scale. Our team solves...in a clear and concise manner to executives and non- technical leaders. You will execute and drive the program/project… more
- Lilly (IN)
- …entire drug development lifecycle is fundamental to Lilly. The purpose of the Manager , GSC Regulatory role is to work with cross-functional, multidisciplinary ... proven writing experience in pharmaceutical industry + Demonstrated experience in technical / regulatory scientific writing. + Strong communication and… more
- Alaka'ina Foundation Family of Companies (Frederick, MD)
- …Clinical Data Manager / Regulatory Writer; Quality Assurance Officer; Regulatory Scientist; Technical Writer; Program Manager ; Biomedical Science ... Regulatory , Clinical, and Technical Clinical Trial...and Volunteer Assistant; Volunteer Recruiter; Senior Volunteer Recruiter; Program Manager /Clinical Portfolio Manager ; Research Records Manager… more
- Amgen (Washington, DC)
- …and agency interactions + Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen ... time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional ...and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US + Provide content for… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid role ... within CMC Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and… more
