- Merck & Co. (Rahway, NJ)
- …Upstream and Downstream Process Development & Engineering. The latter two together form our Biologics' Process Development (BPD) group. This job posting covers ... opportunities for the BPD group. -We are actively looking for highly motivated people with a passion for innovation and interest in contributing to upstream and/or downstream bioprocessing.Responsibilities include but are not limited to: Innovation Develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a physician's perspective- May provide clinical input into the eCRF (Case Report Form ) design, participate in the UAT (User Acceptance Testing) and CCG (CRF ... Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan (IDRP)- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a variety of instructions furnished in written, oral, diagram or schedule form .Follow instructionsSolve practical problems and deal with a variety of concrete ... variables in situations where only limited standardization exists.Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.Knowledge and ability to operate manufacturing, manufacturing-support and lab… more
- Merck & Co. (North Wales, PA)
- …domestic and internationalWrite or answer routine correspondence as directed, ie, form letters with mail mergeMaintain daily calendars, ie, meeting scheduling ... (internal and external meetings), teleconferencing, video conferencing, accepting on behalf of managementEnsure accuracy (ie, proofreading, grammar)Maintain databases, general and department or Division specific applicationsRegularly perform independent basic… more
- Merck & Co. (Rahway, NJ)
- …situations and processes and effectively integrate and synthesize data to form a complete cohesive picture.Proven self-starter with high standards of excellence ... and an innovative mindset.Exceptionally well-developed interpersonal skills and ability to negotiate and influence stakeholders and business strategy effectively.Ability to navigate cross-divisional programs, coordinate projects and processes across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to solve complex study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results ... Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Operations (RO), and other key stakeholders (eg Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA ... annual reports, BTD request etc.).Develop less complex Module 1 regulatory documents (eg cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions.Support FDA meeting preparation including preparation of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ability to lead and work within a cross functional team; ability to form effective working relationships within and external to the medical department Has an ... in-depth understanding of current Pharma landscape and applicable regulations As innovations in the pharmaindustry emerge, is able to identify and implement these practices at Novo Nordisk Extensive knowledge of digital platforms and technological advances in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a variety of instructions furnished in written, oral, diagram or schedule form .Follow instructionsSolve practical problems and deal with a variety of concrete ... variables in situations where only limited standardization exists.Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.Knowledge and ability to operate manufacturing, manufacturing-support and lab… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents, flow charts and Sample Management PlansParticipate in Case Report Form (CRF) development to ensure laboratory sample information is collected for ... sample tracking and reconciliation purposes.Support resolution of informed consent and IRB/EC questions related to biosamples in collaboration with relevant stakeholdersSupport development and update of global DS policies, guidance documents, Standard… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …solve complex study problems. Responsibilities Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results ... Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from 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 Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and… more
- Merck & Co. (North Wales, PA)
- …writing, able to convert complex ideas and information into simple readable form .Strong project management skills; Manage at a program level; influences approach/s ... and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.Demonstrated success in the assurance of deliverable quality and process compliance.Familiarity with statistics and clinical data management… more
- Shimadzu Scientific Instruments (Tampa, FL)
- …search firms to any employee at Shimadzu via email, the Internet or in any form and/or method without a valid written search agreement in place for this position ... (and agency was requested to work the requisition) will be deemed the sole property of Shimadzu. No fee will be paid in the event the candidate is hired by Shimadzu as a result of the referral or through other means. EEO Statement: Shimadzu Scientific… more
- Shimadzu Scientific Instruments (Long Island City, NY)
- …search firms to any employee at Shimadzu via email, the Internet or in any form and/or method without a valid written search agreement in place for this position ... (and agency was requested to work the requisition) will be deemed the sole property of Shimadzu. No fee will be paid in the event the candidate is hired by Shimadzu as a result of the referral or through other means. more
- Merck & Co. (Rahway, NJ)
- …setting, or other setting Broad experience in global benefits area Ability to form effective working relationships at all levels of an organization Ability to ... exercise judgment to drive decisions on routine and non-routine matters within area of practice Ability to further business objectives and appropriately balance divisional/function/corporate business objectives and legal risks on global benefits issues… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and the required submission of final promotional materials to FDA on Form 2253.Learn the importance of regulatory intelligence to help inform the prescription ... drug advertising and promotion landscape.Physical Requirements10%-15% overnight travel required.QualificationsReceived a Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy within the last three years.Strong academic track record… more
- Merck & Co. (Rahway, NJ)
- …Upstream and Downstream Process Development & Engineering. The latter two together form our Biologics' Process Development (BPD) group. This job posting covers ... opportunities for the BPD group.- We are actively looking for highly motivated people with a passion for innovation and interest in contributing to upstream and/or downstream bioprocessing.As an Associate Scientist in BPD you will work with a highly… more
- BioAgilytix (Boston, MA)
- …a variety of instructions furnished in written, oral, diagram, or schedule form Acute attention to detail and excellent organizational, and communication skills, ... highly computer literate.Working EnvironmentPrimarily laboratory environmentExposure to biological fluids with potential exposure to infectious organismsRare exposure to skin and lung irritants, toxic materials, and hazardous wastePersonal protective equipment… more
- Housing Authority of the City of Alameda (Alameda, CA)
- …repair projects. To be considered for this career opportunity, submit an application form (located on the AHA website) and the required supporting documents. This ... position closes on 5:00 PM on Friday, October 4, 2024. Applications will be reviewed as they are received. more
