- Merck & Co. (Durham, NC)
- …management concepts and techniques as they relate to laboratory testing start -up, regulatory requirements for method transfer/validation project timelines and ... Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start -up method transfer/validation… more
- Aequor (Thousand Oaks, CA)
- …zone preferred. The candidate would need to have flexibility to shift their hours to start and end their day at a later time, if additional support is needed for ... the Six Sigma methodology, process mapping and project management experience. Regulatory affairs knowledge will be considered. Any Regulatory … more
- Merck & Co. (Rahway, NJ)
- …to support formulation and process development and document technical reports and regulatory filings. The successful candidate will be key in implementing strategy, ... academia. Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific… 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, ... professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing is accountable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically ... some of the requirements of this role. Demonstrated ability to self- start , be solution-oriented, collaborate effectively with diverse stakeholders, and be… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …utilize prior academic experience to optimize resource allocation, ensure regulatory compliance, and uphold rigorous scientific standards. Understanding best ... ensure research projects are executed efficiently and effectively, and within budget. Regulatory Oversight: Uphold the highest standards of quality and compliance… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …design and implementation of manufacturing processes, instrumentation and equipment start -ups from the laboratory through manufacturing scale of facilities, ... independent and maintains up-to-date knowledge of industry standards and regulatory compliance requirements and independently contributes to the development of… more
- Merck & Co. (Durham, NC)
- Job DescriptionThis role is within a capital project start -up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug ... limited to:Project SupportSupports project team as operations expert through start -up, commissioning, qualification through licensure and ramp up of facility.Author,… more
- Tris Pharma (Monmouth Junction, NJ)
- …and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation, and monitors adherence ... marketing and other cross-functional teams (ie, Medical Affairs, Sales, Regulatory Affairs, Operations, etc.)Collaborates closely with Analytics team to establish,… more
- Merck & Co. (Rahway, NJ)
- …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the ... set up and design during study start up (eg, database set up)Lead medical monitoring team...activities on clinical protocols.Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage multiple competing priorities… more
- Eisai, Inc (Dallas, TX)
- …manufacturer capacity)Strong understanding of pharmaceutical manufacturer compliance & regulatory requirementsDemonstrated success in leading to deliver strong ... team within Eisai.Advanced understanding of pharmaceutical manufacturer compliance & regulatory requirementsAbility to operate a motor vehicle legally, safely and… more
- Merck & Co. (Durham, NC)
- …materials, intermediates, and finished products.This role is within a capital project start -up in Durham, North Carolina. The new facility will include end-to-end ... to; Project Support Supports project team as operations expert through start -up, commissioning, qualification through licensure and ramp up of facility. Author,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to be qualified/validated based on corporate/site guidelines, procedures, regulatory guidelines, and industry practicesStrongly interface with Operations Department ... engineer/scientist during his/her absence.Assist management during internal and external regulatory audits (including FDA, EMEA)Establish key stakeholder relationships with… more
- Merck & Co. (Durham, NC)
- …may include but are not limited to;Support operations production through start -up and commissioning and qualification through licensure and ramp up.Working in ... hands-on training.Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements.Demonstrated ability to work both independently and as… more
- Eisai, Inc (Nashville, TN)
- …prescribing for appropriate patientsStrong knowledge and understanding of the process to start and maintain a patient on therapyDevelop deep knowledge of Alzheimer's ... sales/business analytics, etc.)Strong understanding of pharmaceutical manufacturer compliance & regulatory requirementsDemonstrated success in driving growth and profitability, establishing… more
- Eisai, Inc (Nutley, NJ)
- …Trial Assistant will support all phases of clinical study activities (feasibility, start -up, conduct and close-out) under the direction and supervision by study ... Item follow-up Attends CRO and vendor teleconferences as applicable Review regulatory packet for investigational product release Provide user access management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for building operations activity area readiness activities/processes, aiming to support start of a personalized clinical cell therapy site meeting cGMP requirements. ... the optimization and efficient utilization of the operations spa.Assists in regulatory inspections, perform safety and quality audits, and answer relevant questions… more
- ICON Clinical Research (Brentwood, TN)
- …Institutional Review Board (IRB) Submissions + Collect, review, organize and assemble regulatory initial start -up and maintenance submission packages to Central ... CDP Review Team (CDPRT) and Sponsor. **What you need for Study Start Up Associate I - Regulatory Submissions** * A high school diploma or local equivalent *… more
- IQVIA (Durham, NC)
- …manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award ... resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries,… more
- University of Pennsylvania (Philadelphia, PA)
- …the initiation of Phase I-V clinical trials with a focus on required regulatory start -up approvals and associated site initiation documentation. Reporting to the ... CRU OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs Start -Up Specialist-CC to facilitate, with minimal supervision, the regulatory … more
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