- Merck & Co. (Rahway, NJ)
- …& commercialization Deep expertise in cell culture commercialization and manufacturing operations Strong understanding of regulatory requirements Ability to lead ... objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide the technical leadership and laboratory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process improvements. Build strong relationships with clinical development, clinical sciences , regulatory , biostats, data management, and other key ... a reasonable accommodation. Education:Bachelor's Degree required Experience:10 + years global clinical operations experience including organizational leadership… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs ... VP of Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product… more
- Insmed Incorporated (NJ)
- …understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive… more
- Merck & Co. (Rahway, NJ)
- …drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations )Provide clinical pharmacology support for programs ... Pharmaceutical Sciences , Toxicology, Translational Biomarkers, Translational Medicine Operations , Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory… more
- Merck & Co. (Millsboro, DE)
- …practical experience supporting regulatory inspections, validations and cGMP operations .Required qualifications:Bachelor's degree in a life sciences or ... problem solving.Provide subject matter expertise for product release, aseptic operations , formulation and fill/finish activities.Ensure compliance with corporate and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise ... Legend Biotech is a global biotechnology company dedicated to treating, and one...treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations … more
- Aequor (Fort Worth, TX)
- …2 - 3 years of experience. Custom Fields: Name: Supervisory Org Value: Global Regulatory Affairs Advertising & Promotion(Biatriz Chapa)-60004038 Name: Badge ID ... to promotional practices and guidelines established by the corporation. Bachelor's degree ( Science background will be a plus Excellent command of written and spoken… more
- Insmed Incorporated (NJ)
- …all stages of product development, including Research, Preclinical, Clinical, Regulatory , Operations , Quality Assurance.Innovative thinking and an ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive… more
- BioAgilytix (Durham, NC)
- …policy development, regulatory alignment (GxP/CLIA, GDPR, Part 11), and global data privacy requirements.Build and manage security operations , including ... environment.Adaptable, future-focused leader with resilience and creativity in enabling science and operations securely.Minimum Preferred Technical Skills:Identity… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive...in. Are you?About the Role:You will supports the daily operations of our facilities, ensuring a safe, efficient, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical affairs, or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Insmed Incorporated (NJ)
- … Regulatory , Compliance, Medical Affairs, Market Access, and Commercial Operations team members to align and compliantly execute key tactical ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive… more
- Insmed Incorporated (San Diego, CA)
- …The candidate will collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and external ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...contribute on SOP creation.Who You Are:Bachelor's degree in Life Sciences , Computer Science , Information Technology, or a… more
- Insmed Incorporated (NJ)
- …CAPAs, change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory , Clinical Operations , and Program Management to drive ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive… more
- Insmed Incorporated (NJ)
- …Validation, Quality Management Systems ProcessesWho You Are:Bachelor's degree in Life Sciences , Computer Science , Engineering, or related field preferred.5+ ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... sites, packaging & device development and technology teams, supply chain, operations , quality, analytical, regulatory , and project leaders. The successful… more
- Merck & Co. (Rahway, NJ)
- …Role Summary We are seeking a detail-oriented Procurement Specialist to join our Global Capital Procurement (GCP) team. This role is pivotal in providing operational ... ensuring the smooth functioning of our procurement processes. Reporting to the Global Capital Procurement PMO Lead, the Specialist will collaborate closely with… more
- Insmed Incorporated (San Diego, CA)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive...(CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead… more
- Insmed Incorporated (NJ)
- …Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs, Market Access, Advocacy, and Commercial Operations ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive… more
