- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and workstream implementations for effectiveness.-monitor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... with and understanding of key industry best practices as well as legislative, regulatory and industry artifacts / frameworks, such as, the following: o 21 CRF… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Value process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums ... under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices… 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
- Deloitte (Morristown, NJ)
- Deloitte Risk and Financial Advisory Risk, Data and Regulatory Liquidity - Manager Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, ... Data and Regulatory professionals help organizations identify the regulatory ...smaller engagements or components of large, complex strategy and/or operations transformation engagements + Experience identifying client business issues,… 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… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through ... might include:** + Project Management and leadership in the delivery of regulatory intelligence research services and information + Collaborating on the development… more
- Suburban Propane (Whippany, NJ)
- …through our subsidiary, Suburban Renewables! We have an exciting opportunity for a Regulatory Compliance Manager - Renewable Natural Gas (RNG), who will be ... maintaining, and enforcing company compliance policies and procedures related to RNG operations . In this role, you will also provide guidance on compliance-related… more
- Pfizer (Pearl River, NY)
- …operating guidelines and local regulatory requirements, as applicable. The Study Operations Manager may be responsible to independently take on activities ... **ROLE SUMMARY** The Study Operations Manager will have responsibilities for...+ Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under… more
- Parsons Corporation (Franklin, NJ)
- …looking for. **Job Description:** Parsons is looking for an amazingly talented **Remedial Systems Operations Manager ** to join our team! In this role you will ... and safety measures for operational sites + The experienced operations manager will ensure safe and efficient...operations . + Serve as a company representative on regulatory issues + Gain an excellent understanding of treatment… more
- Bausch Health (Bridgewater, NJ)
- …Agency Partners and Bausch Health Print Production (HH GLOBAL) + Partner with Regulatory Affairs and Regulatory Operations to ensure 2253/OPDP submissions ... our mission of improving people's lives with our health care products. The Manager , Promotional Review Operations is responsible for leading and managing the… more
- Sanofi Group (Bridgewater, NJ)
- …you thought was possible. Ready to get started? This position is for an Outsourcing Manager / BioMarker Operations Manager with expertise in bioanalysis and ... operations in Clinical Outsourcing & BioMarker Operation, Project Operations in TMED (translational medicine and early development). **Main Responsibilities:** +… more
