- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH) ... guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and… more
- Catalent (Philadelphia, PA)
- …required Previous Supervisory experience is preferred Good computer skills, knowledge of MS Office and Inventory Management system are a plus Basic knowledge of ... quality, and/or distribution quality, including quality oversight for material management of materials at Catalent-Philadelphia. Assist in the enforcement of… more
- Catalent (San Diego, CA)
- …that products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPs.Participates in Quality programs, ... all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines.Respond and interact with internal and external… more
- Lundbeck (Philadelphia, PA)
- …of account-specific strategies that improves customer engagement and account management throughout the patient journey, focusing on improved customer experience ... or other relevant commercial or analytical experience 4+ years of Account Management , Marketing, or Sales Management experience with sophisticated matrix… more
- Lundbeck (South Bend, IN)
- …relationships based on customer needs and organizational goals, incorporating "total office " account management . Local Market & Therapeutic Area Expertise ... accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ability to effectively communicate and influence Operations associate and convey information to Management . Ability to work independently and successfully, ... Company Information Legend Biotech is a global biotechnology company...and organizational behaviors skills are required. Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.… more
- Merck & Co. (Rahway, NJ)
- …with other subject-matter experts in the DD team (design controls & risk management , manufacturing, molding, and human factors) and other key partner groups to ... (internal and external)Working knowledge of design controls and risk management processes for medical devices and combination productsExpertise in testing,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program objectives and monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Merck & Co. (Rahway, NJ)
- …NONMEM, Bayesian estimation, MBMA, CTS, QSP)Demonstrated ability to apply appropriate FDA , EMA and other/ICH guidelines in the application of predictive model-based ... or other applicable legally protected characteristics. - For more information about personal rights under the US Equal Opportunity...Hybrid Work Model Effective September 5, 2023, employees in office -based positions in the US will be working a… more
- Merck & Co. (Rahway, NJ)
- …scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS). Leads and participates in the review of electronic case report ... to aid in transfer of electronic data files into the Clinical Data Management System (CDMS). Interface with members of study teams, including external CROs/Vendors… more
- BioAgilytix (Durham, NC)
- …and equipmentPerform duties with minimal Quality Engineer Management oversiteAdditional ResponsibilitiesOther duties as neededMinimum Preferred Qualifications ... - Education/ExperienceBachelor's degree in engineering, information technology, computer science, or related disciplineNot less than five (5) years' experience in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... The Position Responsible for upholding and promoting the Novo Nordisk (NN) Quality Management System (QMS) as the framework that enables the company to manage… more
- Catalent (Manassas, VA)
- …and maintaining the Quality System documentation. Communicate any deviations to management . Assist the Quality Assurance team with special projects as required. ... Food Quality Plan (FQP) standards; Responsible for ensuring compliance with FDA and cGMP standards for Quality Control, including continuous training; Responsible… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …State, Federal and local codes which encompass environmental protection, FDA requirements, OSHA, and hazardous waste-related issuesDirect and coordinate activities ... as neededCoordinate with related departments and functions to assure appropriate information flow and understanding of overall process improvement direction, assist… more
- Catalent (San Diego, CA)
- …and Catalent systems applicable to work performed. Apply ICH and FDA guidanceProactively request assistance when needed to prevent deviations and ... investigationsDevelop time management strategies to ensure work is performed within required...ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents. Good manual… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... will be responsible in handling day-to-day activities inclusive of project execution and management , vendor management , data management , life cycle … more
- Eisai, Inc (Nutley, NJ)
- … Office Suite platform, Outlook, salesforce automation and customer management databases, formulary software and applications (ie FTF), digital communication ... will have the primary role of demand generation by conveying complex clinical information to customers and key stakeholders consistent with the FDA -approved… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing facility, preferably in training/system applications, quality systems, or learning management systems. Knowledge of cGMP regulations and FDA /EU ... Company Information Legend Biotech is a global biotechnology company...oversee the Training team members in collaboration with department management in Operations and Quality to support personalized cell… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH) ... guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and… more
- Tris Pharma (Monmouth Junction, NJ)
- …inventory trends; gathers and analyzes data for potential new products including information /feedback from Food and Drug Administration ( FDA ), pricing databases, ... help support individual and team success.The Sales Operations Associate is an office -based position that assists generic sales and marketing efforts by providing… more
