- Merck & Co. (South San Francisco, CA)
- …Laboratories in South San Francisco is seeking an Associate Principal Scientist with strong expertise in translational cell models, mechanistic pharmacology, and ... analysis, and reporting to project teams, governance bodies, and regulatory agencies.Drive scientific innovation and champion new enabling technologies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical team in preparation of submission documents; authors regulatory documents where necessary with supervision. Health Authority Interactions: ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...this position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for… more
- Merck & Co. (Lower Gwynedd, PA)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well ... expanding your career.We are seeking a highly motivated Associate Principal Scientist to join the Department of Pharmacokinetics, Dynamics, Metabolism, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
- Merck & Co. (Rahway, NJ)
- …the clinical/scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on ... clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in...COVID-19 vaccinations for positions, such as in Global Employee Health , where the Company determines in its discretion that… more
- Merck & Co. (Rahway, NJ)
- …in support of clinical trials. The candidate for this Associate Principal Scientist position should have strong technical expertise in Liquid Chromatography and Mass ... validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical trials.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... adjudication committee setupStudy outputs: Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to… more
- Merck & Co. (Rahway, NJ)
- …and Development (ARD)-at our company's Research Laboratories is seeking a senior scientist to work onsite with extensive experience in validation & qualification of ... work closely with other analytical groups in ARD , Global Quality and Regulatory Affairs-CMC to ensure that validated methods are appropriately transferred from our… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and ... animal health products. Today, we are building a new kind...developing and expanding your career.The Senior Director (Sr. Principal Scientist ) has primary responsibility for the planning and directing… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we ... dedicated colleagues while developing and expanding your career.-- Director (Principal Scientist ) has primary responsibility for the planning and directing of… more
- Merck & Co. (Rahway, NJ)
- …our company's Research Laboratories Division is seeking applicants for a Principal Scientist position available at our company's research facility. The Principal ... Scientist is a senior scientific role tasked with working...program deadlines.Authoring and reviewing internal technical reports, sections of regulatory filings (eg, IND, BLA) and external scientific publications.Experience… more
- Merck & Co. (Rahway, NJ)
- …that enable us to create breakthrough science changing the way we approach animal health challenges.-The Senior Scientist within our company's Animal Health ... Job DescriptionOur Animal Health Research Laboratories team work tirelessly to invent...of development.- -The successful candidate will be a self-motivated scientist with an outstanding scientific track-record and passion for… more
- Merck & Co. (Rahway, NJ)
- …Our team is looking for a strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Have deep fundamental knowledge around large molecule… more
- Merck & Co. (Rahway, NJ)
- Job Description Senior Scientist , Process Cell Sciences (PCS) at Rahway, NJ The Biologics Process Research & Development organization within our company's Research ... energetic individual to join our Process Cell Sciences (PCS) group as Senior Scientist .-In this role, the successful candidate will work closely with team members of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Scientist , Microbiology (Lab Lead) - Analytical Research & Development (Onsite) Small Molecule Analytical Research and ... Development (SMARD) is seeking a highly motivated Senior Scientist -Microbiologist to join the growing Microbiology Center of Excellence (COE).- This position is… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionAt our company, we are committed to improving the health and well-being of people around the world. As a leading global pharmaceutical company, we ... company's Research Laboratories in South San Francisco is seeking a Principal Scientist of In vivo Pharmacology with strong experience in cardiovascular and… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the benefit of patients and global human health . Education and Minimum Requirement: PhD or equivalent degree in statistics/biostatistics or related discipline with a… more
- Merck & Co. (Rahway, NJ)
- …Development, Cell Based Sciences team in Rahway, NJ is seeking a motivated scientist with technical expertise in Biologics Potency assays in drug Development. More ... data in context of broader process and product development.-Working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing … more
- Merck & Co. (Rahway, NJ)
- …clinical assays.Author and review detailed statistical reports suitable for submission to health regulatory authorities, including the US FDA and international ... detailed statistical reports, as well as respond to inquiries from health regulatory authorities.Education Minimum Requirement:Ph.D. or equivalent degree in… more
- Merck & Co. (Lower Gwynedd, PA)
- …DescriptionJob Description:We are seeking a highly motivated and experienced Principal Scientist with established expertise in cell-mediated immunology to join the ... lead group in complex multiparameter data analysis, interpretation and summary.Author regulatory filings and respond to regulatory authority questions pertaining… more
