- Tris Pharma (Monmouth Junction, NJ)
- …incumbent also assists the Legal department with other operational and administrative projects, as needed, (ie, state licensing, intellectual property (IP) ... management, Sunshine Act reporting, etc.), in support of business and legal operations . ESSENTIAL FUNCTIONS Drafts, reviews, analyzes and tracks a variety of… more
- Tris Pharma (Monmouth Junction, NJ)
- …guidelines; Establishes, oversees implementation, and monitors adherence to administrative policies and procedures; Ensures collaborative and compliant communication ... and other cross-functional teams (ie, Medical Affairs, Sales, Regulatory Affairs, Operations , etc.)Collaborates closely with Analytics team to establish, track and… more
- Tris Pharma (Monmouth Junction, NJ)
- …Facilities Maintenance Mechanic I is responsible for Maintenance and Operations support, including but not limited to: maintenance, troubleshooting, repair, ... Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) standards. Performs routine and complex work related to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence ... 0-10% overnight travel required. Qualifications Bachelor's degree in Math, Science, Business Administration or related field is required, with at least 8 years'… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …promotional programs, and overseeing the management of speaker and HCP program operations and technology systems. This position will also lead the development of ... and as needed engagements with full speaker bureau Contracted HCP operations management: Manages Speaker Engagement Plans, monitors metrics to identify trends,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence ... includes ownership of P&L management and strategic resource allocation, on-going operations /reporting and for strategic projects and changes Overall responsible for… more
- Genmab (Plainsboro, NJ)
- …to harness the power of AI, driving digital transformation across our operations . We are looking for an innovation-centric Technical Solution Architect (R&D), who ... roles such as software development, systems engineering or infrastructure administration .Strong knowledge of Research and Development systems and functions such… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound,...resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure adherence to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within Global Oncology Medical Affairs (GOMA) is seeking a Publications Systems and Operations Intern to work closely with the Director of Publications Operations ... friendly (think accessibility, templates, URLs, automation) to reduce the administrative burden of Publication Leads. Education/Experience: Proficient in standard… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard ... Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Key focus… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Financial Disbursements, that manages the day-to-day Financial Disbursement operations (Accounts Payable Processing, Travel and Expense Reimbursement and ... Corporate Card Administration ), processes and strategies as a shared services operation,...of payments. Specifically, this role will be accountable for operations , suggest and collaborate with Financial Disbursement team members… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a ... of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …generation. This position is responsible for preparing necessary reports, providing administrative and other support as needed and assisting with/supporting new ... initiatives/projects and improving the efficiency and/or effectiveness of internal operations of MCT.Responsibilities- Provide MCT system support and access… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a HVAC Automation & Controls Technician (Contractor) 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 role will require systems… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and reviews US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (eg Protocol Amendments, Form 1572s, ... less complex Module 1 regulatory documents (eg cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions and… more
- Merck & Co. (Rahway, NJ)
- …medical contact within the company.Upon request from Global Clinical Trial Operations (GCTO), support Company-Sponsored Trials to enhance the understanding of ... or trial.Recommend potential study sites to Global Clinical Trial Operations (GCTO)/Clinical Research.Address requests from investigators for information regarding… more
- Merck & Co. (Rahway, NJ)
- …validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in ... manufacturing support, familiarity with manufacturing batch record reviews and/or operations .Experience with mathematical modeling, theoretical scaling calculations, drug substance… more
- Merck & Co. (Rahway, NJ)
- …process, primary packaging, compatibility characterization for processing and administration , and supporting regulatory filings.Collaborate with key stakeholders ... development of sterile products for IV, IM, and/or SC route of administration (liquid and lyophilized); (ii) development of complex drug delivery systems including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions include but are not limited to Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative ... or university)- Bachelor's Degree Computer Science, Life Science, Engineering, Business Administration and / or a related discipline required and- Master's Degree… more
