- Aequor (Swiftwater, MN)
- …The Regulatory CMC Specialist may represent RSO on M&S and MSAT project teams when product or valence-related regulatory site expertise is required. Key ... and project managers for the planning and coordination of regulatory CMC activites relating to projects/products from intiation to approval, which include:… 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. Our Quantitative Sciences team uses big...and delivery of efficient, flexible, and modular analysis and reporting and submission standards that can be used for… more
- Eisai, Inc (Nutley, NJ)
- …and concisely in both verbal and written format.Excellent documentation and reporting skills to meet legislative, regulatory , and corporate ... your profile, we want to hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is...from both the strategic and execution perspectives for Eisai. Reporting directly to the Executive Director, IT Security, Compliance,… more
- Aequor (Thousand Oaks, CA)
- …status reporting and stability of Combination Product Operations (CPO) project activities. Manages one or more cross-functional projects of medium to high ... Project Integrator * Candidate will be working primarily...time. The qualified candidate will support verification, validation, and regulatory submissions of these devices. Work within a cross-functional… more
- Merck & Co. (Durham, NC)
- …concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and ... Job Description GENERAL SUMMARY :Our company is expanding its global Bacillus Calmette Guerin (BCG)_vaccine production by adding an end-to-end manufacturing and… more
- Merck & Co. (North Wales, PA)
- … project teams in creating SDTM deliverables for Analysis and Reporting activities and submission.Collaborating with project teams to prepare the ... geographies.Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.Develop and manage project … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and processes reports for the various business stakeholders in Finance, HR, and RD Project Time- Responds to PTO and Time reporting requests by creating ad ... reporting processes by collaborating with various departments and regulatory agencies, analyzing their business requirements, and designing and developing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …efficiency of legal operations Collaborates and drives spend management, analyses and reporting initiatives in partnership with resources at Global Business ... time. EST time zone hours. The Position Will focus on legal billing, reporting , analytics, and projects, you will be instrumental in managing financial aspects,… 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. This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical… more
- Merck & Co. (Rahway, NJ)
- …cross-functional engagement with various departments throughout the company, including Global Safety Environment, Global Engineering Solutions, GWES, ... will also play a pivotal role in supporting internal and external ESG reporting efforts related to financial quantification of data while ensuring our company's is… more
- Merck & Co. (Rahway, NJ)
- …human health.This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders. The Associate Principal ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Is safety representative in cross functional project teams as needed eg Global Project Team (GPT) Plan, execute and drive all activities related to ... safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global … more
- Merck & Co. (North Wales, PA)
- …:This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation ... programming analyst will be a key collaborator with modelers, statisticians and other project stakeholders and is expected to execute project plans efficiently… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting , and publication. Specifically, the Director may be ... Job DescriptionOur company is a global health care leader with a diversified portfolio...or publication; andParticipation in internal and joint internal/external research project teams relevant to the development of new compounds,… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting , and publication.Specifically, The Senior Director May ... Job DescriptionOur company is a global health care leader with a diversified portfolio...or publication; andParticipation in internal and joint internal/external research project teams relevant to the development of new compounds,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years Knowledge and understanding of GCPs and applicable global regulatory guidelines governing clinical trials preferredUnderstanding and experience ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... the data services they provide to support drug development processes and global submissions. This position provides expertise within Data Management by partnering… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well ... independent and maintains up-to-date knowledge of industry standards and regulatory compliance requirements and independently contributes to the development of… more
- Merck & Co. (South San Francisco, CA)
- …leadershipEnsure high-quality data generation, analysis, and reporting to project teams, governance committees, and regulatory agencies, and manage ... well-being of people around the world. As a leading global pharmaceutical company, we strive to make a difference...or efficacy studiesServe as a core member in matrixed project teams and governance committees to drive in vivo… more
