- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and ... those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be responsible for… more
- Merck & Co. (Rahway, NJ)
- …(Non-Sterile) team at the FLEx Center in Rahway is looking for an Associate Specialist - Process Engineer to lead clinical supply manufacturing, scientific ... is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionBiomarker Diagnostics Operations, Associate Principal Scientist, Clinical ResearchWe are currently seeking an Associate Principal Scientist to ... and operational teams to deliver on biomarker and diagnostic objectives, encompassing clinical protocol set-up through assay data generation and filing.-- You will… more
- Novo Nordisk Inc. (Irvine, CA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health- care -provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing… more
- Merck & Co. (Rahway, NJ)
- …in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Associate ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility...include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical… more
- Merck & Co. (Rahway, NJ)
- …validation of Mass Spectrometry based assays that are deployed in support of clinical trials. The candidate for this Associate Principal Scientist position ... Molecular Biomarkers (TMB) is responsible for the development and execution of clinical biomarker assays across all therapeutic areas and all phases of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... innovation and interest in contributing to upstream and/or downstream bioprocessing.As an Associate Scientist in BPD you will work with a highly collaborative team… more
- Merck & Co. (North Wales, PA)
- …the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates...or BS degree with an emphasis in science, health care or related fields.Preferred: Master's, PhD or PharmD degree… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... Experience:- 7 or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience in pharma procurement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Merck & Co. (North Wales, PA)
- …Life Sciences, Engineering, or related field plus 9 years in a clinical trial environment (Analysis & Reporting,- Information Technology, Data Management etc.) in ... Life Sciences, Engineering, or related field plus 6 years in a clinical trial environment (Analysis & Reporting,- Information Technology, Data Management etc.) in… more
- Merck & Co. (Rahway, NJ)
- …and vaccines for the benefit of patients and global human health. The Associate Principal Scientist, Clinical Trial Analysis and Reporting leads the statistical ... programming activities for multiple and/or large/complex late stage drug/vaccine clinical development projects.- Accountability predominantly includes the development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
