- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards for continuous improvement and operations excellence. This may include the review of business partner SOPs and participation in QA initiatives.Partner and ... continuous process improvement activities within QA, as necessary.Participate as a Quality Reviewer for Health Authority inspections in the US, in collaboration with… more
- Merck & Co. (Rahway, NJ)
- …This individual will be expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and ... design control and risk management techniques to positively support...risks within our Company and with external suppliersAuthor and review relevant portions of the regulatory submissions (INDs, IMPDs,… more
- Merck & Co. (Rahway, NJ)
- …capture knowledge gained.Drive new technology development projects through participation in equipment design and testing as well as preparation, review , and ... for and support batch processing readiness and execution activities.Prepare, review , and/or approve GMP Documentation as appropriate.Author/Approve Standard Operating… more
- Merck & Co. (Rahway, NJ)
- …knowledge gained. Drive new technology development projects through participation in equipment design and testing as well as preparation, review , and completion ... and support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard Operating… more
- Merck & Co. (Rahway, NJ)
- …and other functional areasExperience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.Must be innovative and ... tools for subcutaneous biologics absorptionDemonstrated leadership skills and organization design (ie building high performing teams, building talent, and shown… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Clinical Development, an organization dedicated to the effective strategy, design , execution, and interpretation of Oncology clinical trials. Serves as a ... a physician's perspectiveMay provide clinical input into the eCRF (Case Report Form) design , participate in the UAT (User Acceptance Testing) and CCG (CRF Completion… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …paced and results-oriented environment. This role will embody principles of Quality by Design (QbD) as it directly relates to risk-based monitoring (RBM) and Central ... study/CRO plans across the portfolio.Ensure study-specific monitoring plans meet the above standards. Review quality oversight plans that CRO CRAs have in place to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study report (CSR): Leads statistical activities for complex studies including study design , protocol development, CRF review , SAP development, analysis files ... diseases and immune disorders. Summary Position leads complex studies in study design , statistical analysis and interpretation of results with some supervision. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Daiichi Sankyo's mission by leading conversations across functional teams (ie Grant Review Committees) around the grant and/or project decisions that meet the ... Internal Strategy and Operations- In alignment with senior colleagues, collect, review , and make decisions in collaboration with relevant Medical Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study report (CSR): Leads statistical activities for complex studies including study design , protocol development, CRF review , SAP development, analysis files ... immune disorders. Responsibilities:- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
- Genmab (Plainsboro, NJ)
- …in the CDT Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques Represent ... Opinion Leaders meetings, network and/or Partner meetings, as applicable Drive design and synopsis development together with relevant stakeholders Ensure transparent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …excited about exploring the unknown? Does the idea of driving value through human-centered design pull you in? Are you ready to experiment with us? The Position The ... service fees, licensing costs, and outsourced FTE. Support budget coordination and tracking, review and audit all final bills, and assist in the preparation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates ... Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check of data; Works… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThis position will be responsible for facilities engineering support, design , and implementation for mechanical systems and equipment, and work order ... programs for engineering driven initiatives. Serves as SME on engineering design projects; sets project requirements, evaluates compliance with project and… more
- Genmab (Plainsboro, NJ)
- …and scientific objectives.Collaborate with other architects and IT&D functions to design and document innovative and optimal solutions for the R&D space.Evaluate ... reusable and scalable technology components with other functional leaders.Track, review , and provide feedback to the development teams.Leverage Agile methodologies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skills, is well organized, and an outstanding collaborator.Responsibilities- Perform service- design responsibilities for projects and major changes, participate in ... leadership, and external vendors/partners to execute responsibilities.- Responsible for review , approvals, categorizing, prioritizing, of change requests.- Analyze Service… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …excited about exploring the unknown? Does the idea of driving value through human-centered design pull you in? Are you ready to experiment with us? The Position To ... Market Shaping, Field Communications, Call Planning & Alignment, Promotional Review Board, Patient Marketing, Managed Markets, Trade, Corporate Communications,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …time or position works for approximately 37.5 hours per week. Responsibilities: - Review clinical study informed consent forms (Master, country and site level) and ... in an ICF FAQs document used by the Biosample Management team to design informed consent forms for future studies-Present the findings to relevant stakeholders to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …monitor, and maintain job scheduling systems (eg Smart QC, BINOC)Automation: Design and implement automated testing scheduling workflows to optimize system ... following but not limited to: assist with lab cleanings, logbook review , request of logbooks, filing training records, assist with lab… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and are accountable for successful business performance. Leveraging insights to design and drive a differentiated customer experience, they are responsible for ... programs Oversees the management of the advertising agency and promotional review board (PRB) process to implement campaign elements, educational, promotional and… more
