- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection process in collaboration with the study team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... with some supervision. This position also guides contract research organization ( CRO ) programmers and statisticians in preparing analysis files and performing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... project needs. The position works closely with contract research organization ( CRO ) programmers and statisticians and collaborates with internal programmers in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead… more
- Aequor (Thousand Oaks, CA)
- …(clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting) Preferred ... clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company Clinical trial management experience Operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... experts and external KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes effective communication between … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... implementation of sourcing strategies for a specific set of R&D categories ( CRO , Medical Writing, BDM, etc..). Builds strategic plans for specific categories under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... in which Medical Monitoring activities are conducted by the Contract Research Organization ( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... the Clinical Study Teams, Central & Specialty Laboratories, and CROsOversee CRO partner sample management activities per study level including sample tracking,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... Monitoring activities are conducted by the Contract Research Organization ( CRO ) Medical Monitor (MM):- Provides oversight to the ...CRO ) Medical Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO , Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years' experience required5+ years of diagnostic/assay development experience within a pharmaceutical company, CRO or a diagnostic company required.Demonstrated ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...studies to support development of Dx devices under design control process. They will lead identification and selection of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... with stakeholders to ensure a compliant ready state of operation.Ensure that CRO / Vendor quality events/ incidences are adequately reviewed and CAPAs followed up… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... departments within the Company. Also communicates with outside consultants (ie CRO 's) as needed. Qualifications: Successful candidates will be able to meet… more
- Eisai, Inc (Nutley, NJ)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... processes, eTMF user support and training. Engagement with Eisai functional and CRO stakeholders to ensure eTMF users are effectively utilizing the system as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... clinical section of regulatory documents; Oversees management and performance of CRO ; Participates in creation of developmental and regulatory strategy; Drafts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... clinical section of regulatory documents; Oversees management and performance of CRO ; Participates in creation of developmental and regulatory strategy; Drafts… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …preferred.Requires a fundamental understanding of the drug development process and pharmaceutical / biotechnology marketplace, of the preclinical CRO industry, ... and previous demonstrated experience with SalesForce or a similar Client Relationship Management tool.Must have superior professional-level written and verbal communication skills; a high degree of professionalism, excellent judgment, problem-solving and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... goals of the external collaborations. Establish and maintain effective communication between CRO / vendors / ARO. With the Companion Diagnostics Lead, develop a… more
- BioAgilytix (San Diego, CA)
- …experience in GLP/GCLP/GMP quality assurance (QA) Experience working in biotech, pharmaceutical , CRO /CMO or similar organizationSkills: Internal and/or external ... GxP auditing experience Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner Excellent verbal and written communication skills Ability to deal effectively with a diversity of individuals at… more
