- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional ... or existing systems in Regulatory AffairsRequired Skills5 years of Regulatory Operations experienceExtensive knowledge and experience with Microsoft Office,… more
- GEE Group Inc (Columbus, OH)
- …highest standards of safety, health, and environmental responsibility across all their operations . As part of their continuous improvement efforts, we are seeking a ... dynamic and experienced EHS Assistant Manager with a focus on environmental compliance and safety to join this amazing team. Position Overview: As an EHS Assistant … more
- Penske Truck Leasing Co., LP (Lockbourne, OH)
- …We are seeking a candidate to provide leadership at one of our warehousing operations . The Operations Manager II provides leadership to staff to ... 2nd & 3rd shifts. Salary: $78k-$85K. In this role, Operations Manager II will be bonus eligible...processes, and behaviors * Ensure compliance with all applicable regulatory agencies and company policies and procedures * Coach… more
- Creative Financial Staffing (Columbus, OH)
- …with grace. Financial Expertise: In-depth knowledge of accounting principles and regulatory compliance. Requirements For The Accounting Manager : Strong ... Ignite Your Career as an Accounting Manager in Columbus, Ohio! Are you a seasoned...behind our financial stability, overseeing all aspects of accounting operations . Your strategic mindset and leadership skills will be… more
- Creative Financial Staffing (Columbus, OH)
- Accounting ManagerColumbus, OHSeeking a dynamic Accounting Manager , ready to spearhead financial operations . In this role, you'll lead a talented team, ensuring ... roles. Strong knowledge of GAAP and financial reporting standards, ensuring regulatory compliance. Exceptional leadership and team management skills, with a knack… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (eg Protocol Amendments, ... areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence function, responsible for driving...as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Human Papilloma Virus ( HPV) Operations Manager , Training Center Durham's DS4 Operations Training Center Manager ... Responsibilities may include but are not limited to: Partnering with the Operations management team to create and execute learning strategies that support design,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the products reach the people who need them most. The Position As the Manager , Content Operations , you will support Novo Nordisk's strong commitment to its ... operational viability of the product, and anticipating future business needs. The Manager will be responsible for providing content feasibility insights to support… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory ... characterization for drug substance, drug product and reference standards. The Manager must possess a good understanding of pharmaceutical development processes from… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE) This role is primarily accountable for the end-to-end performance ... standards and adverse event reporting-requirements internally and externally.The Clinical Research Manager (CRM) could be responsible for a particular study for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred- 1 or More Years Strong appreciation of the impact of regulatory bodies on pharmaceutical operations . preferred- Experience auditing software vendors ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This position reports to the Director - Accelerated Efficiencies and Optimization, Strategic Operations . The Project Manager regularly works with members of CMR ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan ... A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with current disclosure requirements and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... effort will have a focus related to industry available cell therapy unit operations to be incorporated with an automation platform that integrates with MES systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience ... the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data… 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
- Merck & Co. (North Wales, PA)
- …study specific partners and/or vendors.Core SkillsSolid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... in face-to-face meetings, then your employment may pose an undue burden to business operations , in which case you may not be offered employment, or your employment… more
- Merck & Co. (Durham, NC)
- …and embraces an inclusive team culture including significant interaction with Operations , Quality, Automation, Technology, and other groups as required. Primary ... of inclusion, feedback and empowerment.Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.Ability to read… 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 ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
