Regulatory & Start Up Specialist, Fsp

**Job Overview** The **Regulatory & Start Up Specialist 2** will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance...

RSU Specialist for External Commerce (ComEx) Essential Functions • Responsible for importations and exportation activities in Colombia for our FSP model • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. • Perform start up and site activation activities...

Job Overview The Regulatory & Start Up Specialist 2 will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. ...

**Trial and site administration**: - Tracking (e.g. essential documents) and reporting (e.g. Safety Reports) - Ensure collation and distribution of study tools and documents - Update clinical trial databases (CTMS) and trackers - Clinical supply & non-clinical supply management, in collaboration with other country roles - Manage Labeling requirements and...

**Regulatory Affairs Specialist** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **The Opportunity** This position is sited in **Retiro **(Edificio Laminar) in our **Diagnostics Division**:...

390776BR **SSO Study Start-Up Manager**: Argentina **About the role** 100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO The SSO Study Start-Up Manager is...

Job TitleSr. Regulatory Affairs Specialist.Job DescriptionSr. Regulatory Affairs Specialist.Responsible to execute the regulatory strategies of new product introduction and lifecycle product (renewals, modifications, etc.) by coordinating, compiling, and submitting applications to the regulatory agencies in accordance with regulatory compliance and business...

100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO Site relationship management role to ensure sustainable trial start-up at Site. The Study Start-Up CRA is...

Site Readiness and Reg Snr Specialist **Labcorp is proud to be an Equal Opportunity Employer**: As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not...

The Sr. Site Activation Specialist will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Developing professional...

Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO The SSO Finance Specialist is accountable for budget planning, analytics and payment execution in a direct...

**Site Activation Specialist for External Commerce (ComEx) - Homebased** **Essential Functions** - Responsible for importations and exportations - Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. - Perform start up and site activation activities according to...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve as...

**Labcorp is proud to be an Equal Opportunity Employer**: As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race,...

[16:21] Michelle Christophersen As PPD CAS, the following will be the responsabilities: - Prepares, reviews and coordinates, under guidance, local regulatory submissions therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. - Provides, under guidance local regulatory strategy advice (MoH &/or EC)...

Site Activation Specialist for External Commerce (ComEx) - Homebased Essential Functions - Responsible for importations and exportations - Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. - Perform start up and site activation activities according to applicable...

**Job Overview** Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor’s requirements. **Essential Functions** - Develop Coordinate the development of investigator grants and estimates, contracting strategies...

Job Overview Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor’s requirements. Essential Functions - Develop Coordinate the development of investigator grants and estimates, contracting strategies and...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Developing professional individual contributor who works...