- BioAgilytix (Durham, NC)
- …and/or Data Analytic group for Data Transfer Agreement setup and file transfer. Track Long Term Stability TimepointsEnsure great customer satisfactionDrive process ... uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsPhysical Demands:Ability to work in an upright and /or stationary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scheduling / orchestration tools (Tidal Enterprise Schedule or equivalent), enterprise Managed File Transfer tool (Cleo Harmony or equivalent). Must be able to ... and learning management system.Administration of enterprise job scheduler, Manage File Transfer, Business Intelligence, dashboards, and database environments. Manage… more
- Eisai, Inc (Nutley, NJ)
- …and action items Performs eTMF assist with set-up requests and Assists with filing and archiving project documentation in the eTMF within the defined timelines ... Performs eTMF internal reviews, reconciliation and study file archival Performs detailed eTMF CRO quality check reviews with follow-up for missing documentation… more
- BioAgilytix (Durham, NC)
- …standard office equipment such as computers, phones, photocopiers, and filing cabinetsOccasional weekend, holiday, and evening work requiredPhysical DemandsAbility ... to work in an upright and /or stationary position for up to eight (8) hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipmentOccasional mobility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel Ability to travel up to 20%. In-house ... office position that may require occasional travel (global). Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation,… more
- Merck & Co. (Rahway, NJ)
- …large molecule products.Responsible for process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... successful PPQs and BLAs for the company's pipeline.Manage large multifaceted projects as the leader of a cross-functional team.-Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.Monitors performance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents (SOPs/SOIs), including external data templates, such as External File Transfer Specifications (EFTs), External Data Structure Specifications (eDTS) to ... inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements.… more
- BioAgilytix (Durham, NC)
- …uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsPhysical DemandsAbility to work in an upright and/or stationary position ... for up to eight (8) hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipmentFrequent mobility neededFrequent crouching, stooping, with frequent… more
- BioAgilytix (San Diego, CA)
- …uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsPhysical DemandsAbility to work in an upright and/or stationary position ... for up to eight (8) hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipmentFrequent mobility neededFrequent crouching, stooping, with frequent… more
- Merck & Co. (Rahway, NJ)
- …program is accelerated; has an external business partner; there are multiple indications, the filing is global and/or it is a new disease target with no official ... regulatory guidance.Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labelingIndependently interacts with worldwide regulatory agencies and/or subsidiaries… more
- Merck & Co. (Rahway, NJ)
- …processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to-achieve launch ... on time and uninterrupted long-term supply.Represents CMC and effectively communicates across the governance bodies, stakeholders, and team to drive outcomes/decisions through influence, advocacy, & negotiation with an enterprise mindset.- As the CMC… more
- Merck & Co. (North Wales, PA)
- …or experience developing/leading the regulatory strategy for a product filing /launchUnderstanding of the product development and labeling processExcellent verbal and ... written communication skillsAttention to detail and ability to manage multiple priorities simultaneously.Strong interpersonal skills with ability to demonstrate strategic and analytical thinkingDemonstrated ability to negotiate and influence others… more
- BioAgilytix (Durham, NC)
- …uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsPhysical DemandsAbility to work in an upright and/or stationary position ... for up to eight (8) hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipmentFrequent mobility neededFrequent crouching, stooping, with frequent… more
- Merck & Co. (Rahway, NJ)
- …should have a strong track record in product development/ regulatory filing / drug delivery/ complex formulation and process development/ characterization reflected ... through industry experience and external publications/ patent.- Preferred Experience and Skills: Deep understanding of one or more of the following: surface science, colloid science, particle engineering and/or high concentration formulationsPrior experience… more
- BioAgilytix (Boston, MA)
- …uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsPhysical Demands:Ability to work in an upright and/or stationary position ... for up to eight (8) hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipmentFrequent mobility neededFrequent crouching, stooping, with frequent… more
- Tris Pharma (Monmouth Junction, NJ)
- …with state licensing and compliance requirements, including preparing and filing necessary documentation Manages company's IP portfolio, including trademark and ... copyright filings and renewals Prepares and submits Sunshine Act reports in a timely and accurate manner Manages legal team expense process, vendor invoices and billing relationships and assists with legal team budgeting Assists with managing disputes,… more
- Merck & Co. (Durham, NC)
- …Global Engineering, Quality, and Operations} to ensure a successful technology transfer, filing , and licensure for a new HPV vaccine drug substance manufacturing ... facility.Additionally, this role will contribute to the performance and results of a department, provide validation guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Off-shift and weekend coverage will be… more
- Merck & Co. (Upper Gwynedd, PA)
- …comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation ... activity.Develops, updates, and maintains GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO).Contributes to the development and/ or revision of our Company policies, SOPs and training materials.Develops the strategy for… more
- Everglades Equipment Group (Orlando, FL)
- …of the Aftermarket Manager o Maintains Service Department and Parts Department filing and records o Updates customer profiles using equipment, hours, or other ... information from the customer work orders o Assist in answering service phone calls o Maintains accessories and supplies and prepares replacement orders o May prepare Service Technician efficiency reports and other reports as needed o May process warranty… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(Master, country and site level) and capture key information in an existing excel file template regarding the permitted uses of biosamples and data (training to be ... provided on key information to capture)-Summarize the key findings from each clinical study in powerpoint slides and in an ICF FAQs document used by the Biosample Management team to design informed consent forms for future studies-Present the findings to… more
