- Merck & Co. (Rahway, NJ)
- …R&D, the Crystallization Lab Lead also plays a key role in talent management of junior engineers while driving departmental initiatives.-A high level of innovation, ... with confidence as they discuss technical problems, support pilot plant operations , and interface with cross-functional colleagues/customers in drug substance, drug… more
- Merck & Co. (Rahway, NJ)
- …as they discuss technical problems, support pilot plant operations , and interface with cross-functional colleagues/customers.Education Minimum Requirement: -The ... 11 years of relevant work experience in process development, or a PhD in Chemical/Biochemical Engineering (or comparable) from an accredited college/university with… more
- Genmab (Plainsboro, NJ)
- …internal and external stakeholders, including GCDS Operations , GCDS Systems, Development Operations , Portfolio & Project Management , and CMC. You are skilled ... in handling integration management , process and continuous improvement management , digital or data technology, operations , supply chain, manufacturing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as… more
- Merck & Co. (Rahway, NJ)
- …Oncology Regional Medical Scientific Director, RMSD, is a credentialed (ie, MD, PhD , or PharmD) therapeutic and disease expert who engages in scientific exchange ... medical contact within the company.Upon request from Global Clinical Trial Operations (GCTO), support Company-Sponsored Trials to enhance the understanding of… more
- Merck & Co. (St. Louis, MO)
- …DescriptionRole SummaryThe Regional Medical Scientific Director (RMSD) is a credentialed (ie, PhD , PharmD, DNP, MD) therapeutic and disease expert who engages in ... Studies Program (OTSP)-research studies.-Upon request from Global Clinical Trial Operations (GCTO):-Identify barriers to patient enrollment and retention efforts to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL ... and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data… more
- Genmab (Plainsboro, NJ)
- …Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) Operations Team in Princeton or Copenhagen within commute distance from our office ... Bachelors with 3-5 years experience. Master's degree with +2 years experiences, or PhD 's degree with +1 year of experience, or equivalent of experience.Experience in… more
- Insmed Incorporated (San Diego, CA)
- …and external scientific community, as needed.Assist with coordination and day-to-day management of site operations .Position Requirements: PhD in biochemistry, ... execution of program development from technical development, through manufacturing operations and culminating in the successful preparation of regulatory… more
- Insmed Incorporated (San Diego, CA)
- … PhD in addition to the above10+ years of management experience in ophthalmology clinical development.Pediatric experience preferred.Gene Therapy experience ... clinical development team, partnering closely with heads of clinical operations , toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and… more
- Merck & Co. (Rahway, NJ)
- …be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also have a proven track record ... and critical thinking to advance Biologics and Biopharmaceutics strategyProject management skillsAttention to technical detailBuilds collaborations across internal departments… more
- Merck & Co. (Rahway, NJ)
- …resource needs and contribute to resource allocation internally and through management of business operations and outsourcing budgetsProvide functional ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Insmed Incorporated (San Diego, CA)
- …CRS will provide clinical and scientific support to clinical development and operations , regulatory, medical affairs, drug safety, and quality assurance teams, as ... with team members in the review and development of Data Management activities including data cleaning, eCRFs, edit checks, report development, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as… more
- Merck & Co. (North Wales, PA)
- …cross-functional teams, including US Medical Affairs, Outcomes Research, Commercial, Clinical Operations , Policy and Market Access. They engage with their network of ... per established processManages regional programs (patient support, educational or risk management ) to support appropriate and safe utilization of our company's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Merck & Co. (Rahway, NJ)
- …be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also have a proven track record ... critical thinking to advance biopharmaceutics strategy across the portfolioProject management skillsAttention to technical detailBuilds collaborations across internal departments… more
- Insmed Incorporated (Chicago, IL)
- …InsmedSupport research and development programs as requested by R&D, Clinical Operations , and Medical Affairs Departments. This may include trial site ... and initiativesJob Requirements:An advanced degree in the life sciences field (Pharm D, PhD , MD, and NP/PA) or relevant field medical experienceA minimum of 5 years… more
- Merck & Co. (Rahway, NJ)
- …global Regulatory Affairs subteams, your input will be essential to our operations .You will propose strategies and labeling language during development or in ... Profile Qualifications: A Bachelor's degree in a scientific discipline.Proficient project management skills with the ability to handle multiple tasks and prioritize… more
- Merck & Co. (North Wales, PA)
- …Oncology Regional Medical Scientific Director (Associate RMSD) is a credentialed (ie, PhD , PharmD, DNP, MD) therapeutic and disease expert who engages in ... to achieve study milestonesUpon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies potential investigators to participate… more
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