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Senior Regulatory Affairs Submissions Specialist

Senior Regulatory Affairs Submissions Specialist Our client, a Medtech company based in Galway, now seeks an experienced Regulatory Affairs Submissions Specialist to work in a fast-paced dynamic global team on a permanent basis. This leadership role offers opportunity for global technical regulatory affairs work (e.g., new product development projects, sustaining projects, MDR compliance programs), in conjunction with team leadership and people development. The successful candidate will lead planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations for US, EU and International approvals f...

Job Type:

Permanent

Location:

N/A

Salary:

N/A

Job Ref:

124250

Biostatistician Expert, Biotech

Biostatistician Expert, Biotech Our client is a Biotech company with an exciting pipeline of drug compounds in development, now have approval for a newly created role of Biostatistician as part of the Clinical Sciences team, working closely with Regulatory Affairs, Medical Affairs, Clinical Operations, CMC, and other functions. As the Biostatistical expert you will be accountable for providing statistical input to project development plans, trial designs, clinical trial protocols and reports, briefing packages to authorities and to engage in dialogue with regulatory authorities. This role will provide oversight of outsourced development programs, including oversight of clinical ...

Job Type:

Permanent

Location:

Europe

Salary:

N/A

Job Ref:

124220

Medical Advisor, Global role in CNS

Medical Advisor, Global role in CNS Our client is a Biotech company with an exciting pipeline of drug compounds in development, now have approval for a newly created role of Medical Advisor with a strategic mindset to be a crucial part of the Medical Affairs organisation while supporting all other functions in a small and agile team. The successful hire will together with the Head of Medical Affairs and the cross-functional team develop and execute a global medical strategy and related tactics, appropriately aligned with overall product and R&D strategy. This hire will drive the development of a Scientific Communications Platform and the execution of scientific communication and...

Job Type:

Permanent

Location:

Ireland

Salary:

N/A

Job Ref:

124218

Biostatistics, Senior Manager

Biostatistics, Senior Manager Our client, a cutting edge scientifically driven Biotech company with commercial product and strong development pipeline, now seeks a Biostatistics Senior Manager for their Biostatistics function operating within Clinical Development, in their Dublin office. Flexible hybrid work environment. The Biostatistics Senior Manager will provide statistical leadership and technical expertise in support of clinical development and some post-marketing activities for a therapy area supporting new office / start-up environment. In collaboration with the head of Biometrics and other project statisticians, this hire will build partnership with stakeholders within ...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

124180

Infrastructure Implementations Engineer

Infrastructure Implementations Engineer Our client is an IT Support Services company primarily focused on servicing medium-sized businesses across a wide variety of industries in the Dublin area. They provide infrastructure and security solutions which range from on-premises to hybrid to full cloud solutions, depending on the customer requirements. Our client is currently looking to employ a Level 3 Infrastructure Implementations Engineer to grow our team to service our growing client list. At present we operate a hybrid working model, which means that the role consists of office-based, field-based, and home-based working. Role & Responsibilities: The candidate will be required ...

Job Type:

Permanent

Location:

N/A

Salary:

N/A

Job Ref:

124171