Collaborates with PSL Clinical Safety Physician(s) and cross functional team to develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document..
Author and execute Installation and Operational Qualification (IQ OQ) protocols and reports for.. Author IQ OQ protocols for new or used equipment purchased. Review IQ OQ protocols provided by equipment..
Ensures that regulatory files and data systems are maintained and in compliance with related work instructions and regulations.Collaborates with functional groups to plan, author, compile and..
Collaborates with functional groups to plan, author, compile and submit high quality original applications, amendments, supplements and responses to inquiries from FDA.ORGANIZATION STRUCTUREThe..
He She will triage the issue and will either address directly or forward to the appropriate steward for resolution Author Training Materials Work Instructions Job Aids Organize. Participate in..
Author and maintain training materials and conduct new user trainings. Pull reports and collect and maintain metrics from the various tracking and review systems. Creation of dashboards, along..
Carry out technical support, including user access, system changes, end user issues, user acceptance testing. Author and maintain training materials and conduct new user trainings. Pull reports..
An option for remote work for non field duties is available.Successful applicants must demonstrate their ability to author technical reports, conduct background research, and conduct in field..
An option for remote work for non field duties is available. Senior ArchaeologistSuccessful applicants must demonstrate their ability to author technical reports, analyze archaeological..
Ability to support health authority inspections. Knowledge of data trending and tracking, including use.. Minimum 3 years of relevant work experience, preferably in a health authority regulated environment..
Administer change control activities and corrective and preventive actions.b. Review, approve, and execute test protocols, validation deliverables, and plans as needed.c. Author, review, and..
Assists with development of the Expanded Synopsis and may author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments Assists with and may..
Provides administrative and program support to the Project Director, Principal Investigator, faculty, and other professional staff. There is opportunity to co author publications. Research..
and independently.Must have at least one first author publication in a peer reviewed journal. Preferred Qualifications Prior experience with brain slice patch clamp recordings and optical..
Experience editing CSI specifications. Ability to contribute to or author technical reports. Skills to thrive in a hybrid work environment in which you have frequent and effective interaction..
Formulation Process Development will Technical reviewer and author for NDA readiness activities related to parenteral drug productsWorks with internal and external quality control, quality..
Perform laboratory upgrades (software, desktop components, etc.), Create Review Approve system documentation and author execute test scripts as needed. Role Functions (Functions include, but..
Meet customer needs within SLAs and quality commitment KPIs Propose ideas and recommendations. assist with implementing process improvements Author technical documentation and create..
In this role, you will represent toxicology at cross functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author nonclinical..
In this role, you will represent toxicology at cross functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author nonclinical..
This includes preparation of healthy authority biowaiver requests for manufacturing site changes or.. The Pharmacometrics & Biopharmaceutics Lead will be the primary author for module 2.7.1 for regulatory..
Apply Global Regulatory and cGMP requirements.Ability to support health authority inspections.Knowledge.. preferably in a health authority regulated environment.Previous experience working in a..
Sr. scientists engineers will often defend more complex investigation reports in Regulatory Investigator questioning during Health Authority audits.Knowledge of data trending and tracking..
Administer change control activities and corrective and preventive actions. Review, approve, and execute test protocols, validation deliverables, and plans as needed. Author, review, and approve..
LTSE was founded by Eric Ries, an entrepreneur, New York Times bestselling author, and the creator of the Lean Startup methodology. The role. As VP Product, Private Markets, you will partner..