The IT Security Analyst II coordinates cybersecurity procedures, monitors security services provided by the MSP, and ensures risks are addressed. They also prepare security reports and presentations for senior management, customers, and internal staff.
The Senior Project Manager provides leadership to plan, prepare, and execute high-quality regulatory projects while interfacing with internal departments, sponsors, and vendors. They integrate consulting activities across CMC, quality, regulatory, clinical, and business areas in coordination with other teams.
Lead and provide operational expertise to teams responsible for study start-up and activation, overseeing efficient delivery across all start-up phases at the country, regional, or global level. Ensure activities comply with company policies and procedures, Good Clinical Practice, ICH guidance, and applicable local regulations.
The Principal Medical Writer independently plans and prepares regulatory documents and medical communications to support product development phases. They are responsible for organizing, analyzing, and presenting scientific and statistical information in compliance with ICH and company guidelines.
The Senior Resource Management Manager oversees enterprise-wide resource allocation, capacity planning, and demand forecasting to align staff with project requirements. This role also establishes governance standards and data-driven reporting to optimize workforce utilization across global service lines.
The Principal Clinical Data Manager oversees data management tasks from study start-up through database lock for complex clinical research projects. They lead teams of CDMs, ensure adherence to SOPs, and provide technical leadership and training across the organization.
The Senior Medical Writer plans and prepares regulatory documents and medical communications to support product development. They are responsible for analyzing and presenting scientific and statistical information in compliance with ICH and regulatory guidelines.
The Principal Medical Writer serves as a project leader and primary author for complex regulatory documents across various service lines. They are responsible for mentoring team members and ensuring high-quality documentation that meets global health authority requirements.
The Principal Medical Writer serves as a project leader and primary author for complex regulatory documentation, specifically focusing on CMC submissions. They are responsible for mentoring team members and ensuring high-quality, compliant document finalization across various client engagements.
The Biostatistician II performs analysis of clinical trial data and provides statistical input for reporting results. They work largely independently with minimal oversight to support the delivery of clinical research projects.
The Senior Business Development Director identifies and develops new business opportunities while managing the sales process through contract closure. They also collaborate with internal departments to establish strategic partnerships and enhance the company's market visibility.
The Proposals & Contracts Specialist II is responsible for developing proposals and contracts for new and existing business in consultation with the Sales Team. They lead the execution of complex proposals and may oversee input from other team members.
The Director of Regulatory Affairs provides strategic and operational consulting for clients, managing interactions with health authorities and the FDA. They are responsible for preparing regulatory documentation such as INDs, NDAs, and BLAs while leading cross-functional teams.
The Principal Medical Writer independently plans and prepares regulatory documents and medical communications to support product development. They are responsible for organizing, analyzing, and presenting scientific and statistical information in compliance with ICH and regulatory guidelines.
The Principal Medical Writer independently plans and prepares regulatory documents and medical communications to support product development. They are responsible for analyzing, interpreting, and presenting scientific and statistical information in compliance with ICH and regulatory standards.
The Senior Medical Writer will lead clinical regulatory writing projects and serve as a key contributor to document authorship across various service lines. They will interface directly with clients and support complex engagements as part of a global delivery team.
The Principal Medical Writer plans and prepares regulatory documents and medical communications to support product development. They are responsible for analyzing and presenting scientific information in accordance with industry guidelines and company standards.
