- 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
- 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. (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
- Merck & Co. (Rahway, NJ)
- …experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience ... Management.Education Min. Requirement: BS/BA or an equivalent certification/experience in science , engineering, IT or related discipline with functional working… more
- 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. (Upper Gwynedd, PA)
- …Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance ... assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for assigned… 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 ... other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory… 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 ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team 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
- Merck & Co. (Millsboro, DE)
- …Operations, Manufacturing Quality Control, Media Preparation, Process Improvements, Regulatory Compliance, Safety Practices, Science , Standard Operating ... Procedure (SOP) Writing, Sterilizing Equipment, Test and Evaluation (T&E) {+ 3 more}-Preferred Skills:Job Posting End Date:07/31/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a… 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
- Cynet Systems (Piscataway, NJ)
- …. Pet Food industry experience or a technical background in: Regulatory Science , Quality Assurance. Product Development, Laboratory Sciences, veterinary/animal ... Veeva Technical Input utilizing Veeva software to create those regulatory sections of packaging and placing them on correct...them on correct panels for the copy sheet creation. Regulatory Formula Creation utilizing Excel to create a … 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
- Eli Lilly and Company (Indianapolis, IN)
- …Affairs - CMC commercial solid oral products will use CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop ... CMC science and manufacturing processes. Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes and updating global… more
- Michael Page (Skokie, IL)
- …Food Experience dealing with importing and exporting regulation Bachelor's degree in Regulatory Affairs, Food Science , Pharmaceutical Sciences, Chemistry, or a ... and functional foods, dedicated to advancing health and wellness through science , innovation, and integrity. Renowned for their steadfast commitment to quality,… 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 ... and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.… 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
