- 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 ... activities associated with generating electronic submissions in support of IND /NDA applications.Responsible for the archival of submission and submission related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead… 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 ... following: o 21 CRF 11: Electronic Records, Electronic Signatures o 21 CFR 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs -… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …process transfer and technical support of ongoing biopharmaceutical manufacturing operations . We have Scientist levels I-III available dependent on level ... role is eligible for relocation assistance. Relationships Reports to: Quality Control Manager Number of subordinates with direct/indirect referral: none, this is an… more
- SkyHop Global (Houston, TX)
- …attendants during their layover periods in a multitude of cities. The Transportation Operations Manager is responsible for managing the services and personnel ... Station Leader - IND Houston, IN (http://maps.google.com/maps?q=2346+South+Lynhurst+Drive+Indianapolis+IN+USA+46241) Description SkyHop Globalis one of the premier… more
- Arkansas Government Job (Little Rock, AR)
- ACOM DWS PROGRAM OPERATIONS MANAGER Date: May 1, 2024 Req...+ Perform other related duties as assigned by AAS Manager or the ind iv idual responsible for ... Automated Adjudication System Unit Position Summary The ACOM DWS Program Operations Manager is responsible for managing and supervising all aspects of the… more
- Forward Air (Folcroft, PA)
- Position: Operations Manager Job Description: Forward Air is seeking a capable and career-oriented Operations Manager to lead our fast-paced ... disciplinary recommendations when necessary. This position reports directly to the Terminal Manager . Core Responsibilities & Duties: + Ensure all work is performed… more
- Actalent (Montclair, NJ)
- We have openings for a Project Manager , Clinical Operations with the largest, most comprehensive and integrated health care network in New Jersey, offering a ... protocols, informed consent forms, monitoring and validation plans. + Oversees submission of IND Application to FDA as needed. + Designs case report forms and… more
- System One (Florham Park, NJ)
- Title: Manager /Senior Manager US Regulatory Affairs - Global Development Projects Location: Remote Type: Contract Rate: 52-70 (DOE) Start Date: ASAP Leading ... Pharmaceutical Company located in NJ is hiring a Manager /Senior Manager US Regulatory Affairs - Global...strategies for multiple clinical development projects at all stages (Pre- IND through NDA submission and approval). + Support and… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Project Manager A/B Job Profile Title Manager Research Project A Job Description ... and industry initiated, different disease states and varying complexities. Project Manager work includes overall management of research projects, supervision of… more
- CDM Smith (Philadelphia, PA)
- …alternate paths based upon performance and metrics. **Job Title:** Industrial Project Manager - Civil Geotech **Group:** IND **Employment Type:** Regular ... **37397BR** **Requisition ID:** 37397BR **Business Unit:** IND **Job Description:** CDM Smith has an exciting...CDM Smith has an exciting opportunity for a Project Manager focused on geotechnical investigations for electrical transmission work… more
- University of Pennsylvania (Philadelphia, PA)
- …development. * Identify/implement new technology/systems required to enhance clinical research operations . The Senior Clinical Trial Project Manager will ... and resources, and much more. Posted Job Title Senior Clinical Trial Project Manager (Center for Cellular Immunotherapy) Job Profile Title Clinical Research Project … more
- Charles River Laboratories (Durham, NC)
- General Manager Req ID #: 222651 Location: Durham, NC, US, 27703 For 75 years, Charles River employees have worked together to assist in the discovery, development ... Manage** r is responsible for directing the site to ensure integrated site operations and participate with senior Safety Assessment (SA) management and other Site… more
- WuXi AppTec (Austin, TX)
- **Overview** The Project Manager II will manage and coordinate clinical and/or data project services for sponsors to assure project/program milestones are met ... **Essential Job Functions:** + Provides operational support for Clinical Operations + Oversee all aspects of clinical, data, and/or...+ Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations + Other duties as… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …researching if the study is federally funded and has an Investigational New Drug Application ( IND ). + Verifies the IND status in the study protocol, eIRB, or FDA ... problem solving, negotiation, and continuous quality improvement methods in daily operations . + Works collaboratively and professionally with OCR staff, the Emory… more
- Amazon (IN)
- …metrics for workforce management. * Communicate and interact effectively with operations and specialist functions to provide internal customers with information/data ... candidates to work out of one of the following locations: Bangalore, KA, IND | Hyderabad, TS, IND | Virtual Location - KA | Virtual Location - MH | Virtual… more
- Beth Israel Lahey Health (Boston, MA)
- …(essential) + Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations ... and deviations to study protocols. Oversee reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support… more
- Beth Israel Lahey Health (Boston, MA)
- …and monitoring of investigators who hold Investigational New Drug ( IND ) applications, and Investigational Device Exemptions (IDE). Responsible for overseeing ... submissions to the Institutional Review Board (IRB) for consistency related to IND /IDE requirements. Monitor investigators' adherence to FDA requirements for IND… more
- University of Pennsylvania (Philadelphia, PA)
- …programs and resources, and much more. Posted Job Title Myeloma Research Program Manager (Cancer Center) Job Profile Title Manager Research Project B Job ... Teams that support disease/discipline specific cancer programs within the ACC. This Program Manager will have oversight of the ACC CRU- Myeloma Research Team. The… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Sr Manager External Manufacturing position. This position strategically leads business relationships and/or facilitates day-to-day ... operations with Contract Manufacturing Organizations (CMOs) and Partners through...(IOPS) product supply chains. The role of the Sr Manager External Manufacturing is to act as the Relationship… more
