- Merck & Co. (North Wales, PA)
- …personalized and effective while staying meaningful and compliant.This-Digital Channel SME will collaborate with Marketing/Promotion and agile Digital Engagement ... including Sales, Sales Leadership, Account Executive Leadership, US Market Operations , IT, Training, Compliance, Legal, and Communications.-Key responsibilities of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and internal audits for PV operational activities for NAO; participate in audits/inspections as Subject Matter Expert ( SME ) and mentor colleagues/direct ... relating to technical complaints, adverse events and other safety information in the US and Canada. Overall responsible for...Will serve to represent the Patient Safety department as subject matter expert in cross-functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …audits.Supports Quality risk assessment teams.Review/approve documents as a Quality on the Floor Subject Matter Expert ( SME ).Remain current in skills ... instructions.Develop positive relationship with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations … more
- Merck & Co. (Upper Gwynedd, PA)
- …findings, responses and Corrective Action and Preventive Action (CAPAs), worldwide.Acts as the subject matter expert and primary point of contact for ... data from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of Clinical Quality Operations (HCQO),… more
- Merck & Co. (Rahway, NJ)
- …extensive collaboration with manufacturing sites and global GMP SMEs.-Job Function:serve as a subject matter expert for good manufacturing practices (GMP) ... and devicessupport remediation activities and pre-approval inspection readiness activitiesprovide expert guidance and assistance to our company's manufacturing sites… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to end. Ensure thorough root cause analysis, impact assessment, and CAPA/EC determination.Serves as Subject Matter Expert ( SME ) in preparation for and ... is seeking an Investigator I or Investigator II as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Investigator will be part of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …EBR designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives ... seeking a MES Engineer as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe MES...with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Medical Director serves as the subject matter expert for our products and related data within a ... Key internal relationships include Field Medical Affairs, Medical Strategy & Operations , Medical Information , Publications, Clinical Directors, HEOR Directors,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as the point of contact for daily distribution of process materials, subject matter expert for operations inventory management and point of contact for ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Inventory Control Specialist as part of the Technical Operations … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and provide coordination to ensure timely and compliant implementation of process improvements.Serves as Subject Matter Expert ( SME ) in preparation for ... myeloma.Legend Biotech is seeking Investigation Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR -T Investigation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical/Medical Information , Regulatory, and Marketing Management of all system users/participants Subject Matter Expert ( SME ) for annual Corporate ... successful completion of promotional initiatives. Relationships Reports to Director, Marketing Operations . Primary interaction is with teams that submit into PRB (eg… more
- Merck & Co. (Durham, NC)
- …responsible for maintainingstandard work.Attend any required project meeting as a subject matter expert for BCG Production Operations and schedule other ... dedicated colleagues while developing and expanding your career.Teknika vaccine manufacturing operations area is seeking a Lead Production Technician. The Teknika… more
- Merck & Co. (Rahway, NJ)
- …final reports and publications summarizing data, and writing/updating lab SOPs.Serve as a subject matter expert in mass spectrometry-based assay development ... and validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data standards and data cleaning needs for DS Programs / Studies.- Serve as the subject matter expert for Study Data Managers during the planning/start-up, ... of External Vendors by engaging with key cross-functional stakeholders (Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing data collection,… more
- Merck & Co. (Rahway, NJ)
- …the team and/or department via presentations to key partner groups or serving as a subject matter expert during GxP audits and inspections. Fostering strong ... partnering with Development Quality, Process Research & Development, Pharmaceutical Operations , and other parts of the AR&D organization in...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Merck & Co. (Rahway, NJ)
- …of mentoring individuals in a peer-to-peer fashion and as a technical mentorRecognized as a subject matter expert in at least one drug delivery and/or ... a robust formulation and manufacturing processRecognized as a technical expert and scientific contributor with proven ability to identify...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process optimization, customer technology transfer activities with project management assistance.Provide SME information on the request for pricing (RFP) ... qualification, packaging and labeling. This position will interface with Operations , Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking Facility Engineer as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible ... of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the… more
- Merck & Co. (Durham, NC)
- …(eg, System Owners, Process Owners, Data Owners, Business Unit, Technical Units and Subject Matter Experts) to assess and remediate legacy systems and ... safety or data integrity. Work closely with stakeholders and SME 's from site operations , quality operations...- Requirements: Must possess a Bachelor's degree in Science, Information Technology, Engineering and at least 5 years of… more
- Merck & Co. (Durham, NC)
- …with cross-functional teams (ie Maintenance, Global Engineering, Quality, and Operations } to ensure a successful technology transfer, filing, and licensure ... validation activities by maintaining systems in a validated state.Provide SME knowledge for manufacturing, utilities and facilities investigations by authoring… more
