- Merck & Co. (South San Francisco, CA)
- …the assessment of drug candidates. The successful candidate will join a dynamic Data Science team focused on bringing AI/ML approaches to bear to improve the speed ... enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role in developing,… more
- Merck & Co. (Rahway, NJ)
- …leadership and functional capability to keep pace with the changing science and regulatory environment.Establishing and effective implementation and oversight ... precedent setting.- Guides internal teams to implement rigorous, innovative, and science -based approaches to regulatory interactions and requirements.- Uses… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company initiatives. Qualifications:Education and Experience: Bachelor's Degree in Life Science required.M.S./ PhD . preferred in a scientific discipline. MS ... diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a high-performing organization that:Attracts and cultivates essential skills needed for data science and AI, ensuring the team remains at the forefront of industry ... but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven insights… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Medical Science Liaison (South Central) as part of the Medical Affairs team based in ... Role OverviewAs part of the US Medical Affairs team, the Senior Medical Science Liaison (MSL) will be responsible for engaging identified key opinion leaders (KOLs)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Insmed Incorporated (San Diego, CA)
- …industry, come to Insmed to accelerate your career.RecognitionsConsistently Ranked Science 's Top EmployerInsmed is dedicated to creating a collaborative environment ... thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's...(CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Genmab (NJ)
- …compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Merck & Co. (North Wales, PA)
- …Processes, Clinical Trials Analysis, Data Analysis, Data Management, Data Science , Numerical Analysis, Physiology, Regulatory Compliance, Regulatory ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Insmed Incorporated (San Diego, CA)
- …industry, come to Insmed to accelerate your career.RecognitionsConsistently Ranked Science 's Top EmployerInsmed is dedicated to creating a collaborative environment ... where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named… more
- Merck & Co. (North Wales, PA)
- …Drug Development, Ethical Standards, ICH GCP Guidelines, Life Science , Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Formation Bio (New York, NY)
- …performance to executive leadership and external partners About YouRequired Qualifications PhD in Computer Science , Biomedical Engineering, Medical Physics, or ... to integrate imaging AI solutions into trial protocols and workflows Partner with regulatory teams to ensure imaging biomarkers and AI models meet FDA standards for… more
- Merck & Co. (Rahway, NJ)
- …are our Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science , and technology, we collaborate to deliver the next medical ... shape and drive innovation across the Biologics pipeline, strategy, and science .Anticipate and solve scientific and technical challenges across projects and… more
- Merck & Co. (North Wales, PA)
- …Life Science , Medical Writing, Motivation Management, Prioritization, Project Management, Regulatory Compliance, Regulatory Documents, Science {+ 4 ... specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other company Research… more
- Genmab (NJ)
- …and approve any amendments, corrections, and updates of data packagesSupport regulatory submission/filing activitiesRequirements: Master's or PhD in a ... compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best… more
- Aequor (Thousand Oaks, CA)
- …of engineering principles applied to physical systems. The candidate holds either a PhD with no required industry experience, a Master's degree with at least 2 ... experimental data into actionable insights. Candidates with degrees in Computer Science , Electrical Engineering, or Computer Engineering, or those with purely… more
- Formation Bio (New York, NY)
- …development through commercialization. You will oversee internal and external teams, ensure regulatory compliance, and play a key role in scaling our biologics ... capabilities in partnership with technical, quality, and regulatory leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies… more
