- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data… more
- Aequor (Newbury Park, CA)
- …processes and deliverables. Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission of ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global ... other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM)… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...related to US/Ex-US regulatory submissions. In addition, this individual will be responsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready? The Position As a member of the Total Rewards CoE, the Global Employee Shares Manager will be responsible for managing and administering the ... company's global employee share plans. This includes ensuring compliance with...with Legal and Finance stakeholders to ensure compliance with regulatory requirements and internal policies Work closely with Mobility… more
- Aequor (Newbury Park, CA)
- …and develop solutions. Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and deliver training ... This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works...materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... for supports of strategic leadership to manage DSI QA Functional activities and Global QA activities. This position performs support tasks Head Global R&D… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That ... 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… more
- Aequor (NJ)
- …/ Strong knowledge of the global drug development process and global regulatory requirements. Proficient and strong analytical skills. Strong communication ... 100 % remote Manager prefers local candidates (will consider non local...and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.… more
- Merck & Co. (Rahway, NJ)
- …Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality ... HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes ... a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business expectations to execute … more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... improvement projects within the department and/or in collaboration with global colleagues. Relationships Reports to the Director, Quality Assurance. Regularly… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour ... operations team for the site.- The Manager will direct a team of hourly personnel who...plant maintenance and spare parts procurement systems.Working knowledge of regulatory requirements in accordance with GMPs.Ability to work in… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... are on time and within budget to support drug development processes and global submissions. This position also partners with internal and external stakeholders to… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide ... of the team (eg documentation, housekeeping, area 5S, etc.)Participate in safety/ regulatory audits (ie tours, topic discussion)FinancialCoach the team to ensure SAP… more
- Lundbeck (New York, NY)
- …be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative ... lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the...as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines).Provide QA Technical support during the development and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... data services they provide to support drug development processes and global submissions.This position provides expertise within Data Management by partnering with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to identify potential safety signals, tracks safety signals in the global electronic signal tracking tool and performs safety analysis/evaluationMay contribute to ... Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes to regulatory authority requests or communication for assigned clinical studies - CTD… more
- Lundbeck (Bronx, NY)
- …be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative ... and psychiatry. Join us on our journey of growth!As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio to Psychiatrist and… more
