- Insmed Incorporated (Bridgewater, NJ)
- …archiving of submission and submission related documents in the Company 's electronic document management system ... Company DescriptionInsmed is a global biopharmaceutical company...validation and migration activities relating to new or existing systems in Regulatory AffairsRequired Skills5 years of Regulatory Operations… more
- Merck & Co. (Boise, ID)
- …projects according to instructions and technical manuals using knowledge of electronic , and mechanical systems or components.Develop and oversee assembly ... technician fabricates and wires equipment used in the RFID systems for Fish and Wildlife. Assists in the RMA...duties listed above, all positions are also responsible for:Meeting company standards pertaining to quantity and quality of work… more
- Catalent (Harman, WV)
- …regulations (21 CFR Part 600s) or EU GPs, a plusProficient with electronic systems , including developing and producing reports.Experience with data analytics ... Position Summary The Director, Quality Systems is responsible for the management and oversight...quality metrics for Senior Management review, and other quality system functions, as needed. The Role Provides strategic direction… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …objectives. Ability to identify/remediate gaps in processes. Operational experience with electronic quality systems is required. Proficient with using Microsoft ... Company Information Legend Biotech is a global biotechnology...treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations… more
- Merck & Co. (North Wales, PA)
- …experience with sampling strategies for large databasesExperience working with coding systems such ICD-9, ICD-10, CPT, NDCUnix operating system experience; ... regulatory submission deliverables for Real World Evidence projects across the company 's Biostatistics and Research Decision Sciences (BARDS) group.- The principal… more
- Merck & Co. (Rahway, NJ)
- …system Installing, maintaining, and repairing ventilation and air-conditioning systems and equipment Identifying maintenance risks on equipment Diagnosing ... Assisting with customer inquiries Supports a Target Zero Safety culture Utilizes electronic technologies; electronic work order systems , e-training, and… more
- Merck & Co. (Rahway, NJ)
- …strong attention to detail in completing GMP documentation, proficiency in electronic systems , and participation in continuous improvement projects.- Positions ... to maintain good manufacturing practice (GMP) operations, using paper-based and electronic systems .Maintains detailed knowledge of process equipment and… more
- Merck & Co. (Boise, ID)
- …conducts routine and emergency site visits to maintain or repair our company 's Animal Health Aqua technology systems inclusive of radio-frequency identification ... may include, but are not limited to:Installation and maintenance of our company 's animal health Aqua technology systems .Remote monitoring and diagnosis of… more
- Merck & Co. (Durham, NC)
- …maintenance/calibration work instructions. The Senior Calibration Technician will use computerized systems such as SAP for PM data entry and report generation. ... and when required calibration activities to ensure applicable equipment and systems are maintained in a compliant state.Maintains the integrity of equipment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …compliance. This includes implementation, optimization and management of the labeling Electronic Document Management System (EDMS) and the labeling milestone ... Job Description Join a Legacy of Innovation 110 Years and Counting! Company is committed to diversity and inclusion. We are an equal opportunity employer including… more
- Merck & Co. (North Wales, PA)
- …Engineering or related field with a minimum of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. MS (preferred) in ... or related field with a minimum of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. Required Experience and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Ensuring appropriate electronic storage and management of documents in electronic patent document management systems Managing and supporting data/docket ... related issues in PAIR and other patent document management systems Independently communicating with patent authorities, agents, and third...longer good enough to aspire to be the best company in the world. We need to aspire to… more
- Merck & Co. (Durham, NC)
- …of the project proceed in compliance with cGMP, regulations, and our Company 's Quality Management System .Supporting areas such as Design, Commissioning, ... supply to customers and patients on time, every time, across the globe.Our Company will construct a new manufacturing facility to significantly expand its production… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …skills (MS Office and clinical trial systems ) and adaptability to new systems . Working knowledge of electronic trial master files and clinical trial ... assigned clinical trials, document management and management of clinical trial management systems and archiving systems . Relationships Reports to a Manager (or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of Quality systems . Experience in management of retain samples using electronic systems (eLIMS). Candidates must be able to accommodate shift schedule. ... Company Information Legend Biotech is a global biotechnology...laboratory and ability to identify gaps in processes or systems . Proficient with using Microsoft Office applications (Outlook, Excel,… more
- Merck & Co. (Rahway, NJ)
- …in a country in compliance with ICH/GCP and country regulations, our company 's policies and procedures, quality standards and adverse event reporting requirements ... at study closeout. Oversees FCPA, DPS/OFAC, and maintenance of financial systems . Financial forecasting in conjunction with Sr.COM /other roles.Executes and oversees… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …specific to eDiscovery, and data management. Essential Functions Advance the company 's goals of risk mitigation, cost containment and transparency, and increased ... Oversee implementation of enhanced legal hold and eDiscovery workflow management system and lead efforts to reengineer related business processes and redefine… more
- Merck & Co. (Durham, NC)
- …environmental monitoring during processing and records results in the computerized database system - Provides timely delivery of sample and other materials as ... and Skills:BioWorks Certificate (working in an FDA regulated industry)Experience utilizing System Applications and Products in a manufacturing setting - Use of… more
- Tris Pharma (Monmouth Junction, NJ)
- …and regulatory guidance documents Proficiency with drug safety databases (ie, Argus), electronic data capture (EDC) systems , Medical Dictionary for Regulatory ... Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …proposals/quotes from calibration/equipment suppliers Create purchase order requisitions using internal electronic system including tracking / status of orders. ... all positions 36 Paid days off including vacation, sick days & company holidays Health Insurance, Dental Insurance, Vision Insurance Guaranteed 8% 401K contribution… more
