Senior Specialist, Regulatory Operations - Frederick, MD

The Senior Specialist, Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems applications and tools including supporting sys ...

This position involves preparing regulatory documentation and maintaining filing systems. · ...

Achieving our goals starts with supporting yours. Grow your career, access top-tier health and wellness benefits, build lasting connections with your team and our customers, and travel the world using our extensive route network. · Come join us to create what's next. Let's define ...

Achieving our goals starts with supporting yours. Grow your career access top-tier health and wellness benefits build lasting connections with your team and our customers travel the world using our extensive route network come join us to create whats next lets define tomorrow tog ...

Otsuka's internship program offers students hands-on experience and develops critical skills while contributing to meaningful projects. · ...

+Otsukas internship program offers students hands-on experience developing critical skills while contributing to meaningful projects. · The Clinical Transparency Intern will support Clinical Trial Disclosure activities related to registration and results disclosure of OPDC-sponso ...

Zachary Piper Solutions is seeking a Clinical Research Monitor to support a company focused on advancing FDA‑regulated medical product development. · This position is hybrid at Ft. Detrick, · Frederick,Maryland. · The Clinical Research Monitor will conduct clinical trial monitori ...

Zachary Piper Solutions is seeking a Clinical Research Monitor to join a leading federal health IT solutions provider located in Frederick MD. This is an opportunity for work that makes a real impact on the world around you. · ...

The Director/Senior Director of Clinical Operations will provide strategic leadership and operational oversight for the execution of key, high-priority clinical trial programs within our portfolio. · Lead clinical operations strategy and execution for CAR-T and autoimmune disease ...

The Director/Senior Director of Clinical Operations will provide strategic leadership and operational oversight for the execution of key, high-priority clinical trial programs within our portfolio. · The position is accountable for the successful planning, resourcing, and flawles ...

Piper Companies is looking for a Clinical Research Monitor to join a federal government–supported organization located in Frederick, · Maryland.Develop Clinical Monitoring Plans and oversee single-site and multi‑center clinical studies · Conduct remote review of electronic source ...

We are seeking a motivated and detail-oriented cGMP Cleaner to support operations within a regulated pharmaceutical manufacturing environment.This role plays a critical part in maintaining cleanroom standards, supporting compliance, and ensuring the facility meets all regulatory ...

MASAI Technologies Corporation (MTC) is seeking an experienced and dynamic Business Operations Manager to oversee and optimize operations for Commercial, Federal Contracts, and other Public Sector projects. · Conduct in-depth market analysis in IT and real estate sectors to ident ...

The Alarm Management Technician is responsible for monitoring and responding to alarm systems in pharmaceutical manufacturing environments. · Monitor alarm systems in real time. · Anounce and assess causes of alarms, following established procedures. · Respond to alarms by conduc ...

Operate filler equipment of various product families following regulatory standards. · ...

Operate filler equipment of various product families following regulatory standards. · ...

Tonix Pharmaceuticals is seeking Senior Director of DMPK & Bioanalysis (BA) to provide strategic scientific operational leadership for Bioanalysis (BA), drug metabolism distribution pharmacokinetics (PK), and pharmacodynamics (PD) activities across Tonix's discovery and developme ...

+Plans and coordinates health and safety programs by analyzing, updating and controlling work processes. · +Competitive base salary · Team-based profit-sharing program · 401K for all employees with 3.5% company match · ...

+ Lead the establishment and operational readiness of the Occupational Health Clinic · + Develop clinical protocols, policies, and procedures to ensure regulatory compliance · + Ensure compliance with applicable federal, state, and accreditation standards including OSHA regulatio ...

+Job summary · Piper Companies seeks a Technical Writer to support biopharmaceutical client operations. · +Create and maintain documentation for facilities operations. · Format using Microsoft Word and Excel. · ...