Req ID:

R010768

Locations:

Mississauga, ON, CA; Cambridge, Cambridgeshire, UK; London, UK; Carlsbad, CA; Palo Alto, CA; Philadelphia, PA -- [Remote/Home-Based]

Category:

Research & Development

Brief Description: The Associate Director, Medical Writing, is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables within one or more program. S/he will work directly with cross functional teams to author regulatory documents (eg, protocols, clinical study reports, briefing books, submission documents, investigator brochures). For programs …

Req ID:

R010805

Locations:

London, UK; Philadelphia, PA -- [Remote/Home-Based]

Category:

Research & Development

The Director, Clinical Trial Feasibility & Site Intelligence is responsible for developing and overseeing strategic feasibility and site intelligence processes to inform clinical trial planning and provide clinical trial sites across the Jazz clinical trial portfolio. The role is responsible for process and resources that leverage cross functional expertise, analytics …

Req ID:

R010806

Locations:

London, UK; Philadelphia, PA -- [Remote/Home-Based]

Category:

Research & Development

Brief Description: The Director, Clinical Trial Start-Up is responsible for the strategic leadership and operational oversight of the Study Start-Up (SSU) process and staff. This role directs SSU planning, the development and optimization of end-to-end SSU processes and oversees the performance and development of SSU staff across multiple clinical programs. …

Req ID:

R010824

Locations:

Boston, MA; Trenton, NJ; Albany, NY; Philadelphia, PA -- [Remote/Home-Based]

Category:

Research & Development

Summary The Manager, Regulatory Affairs Global CMC will be responsible for CMC regulatory support of commercial/development projects worldwide. Essential Functions Ensure continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessments. Coordinate with other team members to manage regulatory assessments for changes …

Req ID:

R010202

Location:

Palo Alto, CA -- [Remote/Home-Based]

Category:

Research & Development

Brief Description: As a member of the REMS Strategy and Operations department, the Senior Manager, REMS Data Programmer will provide support for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs and other patient and product risk management initiatives. This role reports to the Associate Director, REMS Analytics and Reporting …

Req ID:

R010843

Location:

Philadelphia, PA -- [Remote/Home-Based]

Category:

Research & Development

As a member of the REMS Strategy and Operations department, the Senior Manager REMS Project Management will provide support for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs. This role will support the Director level of the department in multiple department initiatives in the US. This role provides management …