- Actalent (Jacksonville, FL)
- …documents, including Protocols & Amendments, Clinical Study Reports (CSRs), Investigator Brochures, and Meeting Briefs. + Work collaboratively across functions ... Contribute to both clinical and regulatory writing processes, ensuring accuracy and compliance . Essential Skills + 10+ years of medical writing experience. +… more
- Merck (Tallahassee, FL)
- …of local data generation study concepts and protocols. + Reviews Investigator -Initiated Study proposals from key countries prior to headquarters submission (ex-USA). ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents… more
- Actalent (Orlando, FL)
- …within the Research Institute, overseeing the conduct of industry-sponsored and investigator -initiated clinical trials. This role ensures compliance with trial ... protocols, FDA regulations, and ICH/GCP guidelines. The specialist acts as a clinical study coordinator when necessary and is responsible for training, mentoring, and developing clinical study coordinators and research staff across various US Division… more
- University of Miami (Doral, FL)
- …Ability to communicate effectively in both oral and written form. + Ensuring compliance with local, state and federal health regulations. + Knowledge of and ability ... care with research staff. + Participates in clinical research as an investigator + Obtains complete medical history independent of supervision by the physician.… more
- J&J Family of Companies (Miami, FL)
- …areas of interest. The MSL provides research support for the company and investigator -initiated research. The MSL will function with high integrity and follow credo ... all activities in accordance with current regulatory and health care compliance guidelines. + Ability to travel, primarily throughout assigned geography, with… more
- Takeda Pharmaceuticals (FL)
- …with facilitation of strategically aligned medical collaborative studies and investigator -initiated research processes * Display advanced knowledge of therapeutic ... cross-functional teams * Execution of activities within legal, regulatory, and compliance requirements Travel requirements: * Frequent travel is required; must be… more
- Bayer (Tampa, FL)
- …FDA guidance for distribution of scientific information; + Adherence to SOP and compliance guidelines for all external contacts; + Prepares and presents data to ... projects aligned with medical and brand strategy; including facilitating investigator -initiated research (IIR) and research site identification; + Responsible for… more
- MyFlorida (Tallahassee, FL)
- …relating to the regulation of educator licensure; investigations; case management; compliance and monitoring; data management; development and delivery of technical ... or other disciplinary actions against certified educators. + Assists the investigator with scheduling, notifying, and/or conducting the informal conference. +… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …pharmacology** sections for regulatory filings, including annual reports, investigator 's brochure, IND/NDA/BLA applications and pediatrics development plans in ... compliance with relevant guidelines and standards. + Work with pharmacometricians, support **model-based drug development (MIDD)** strategies, and provide input to… more
- University of Miami (Miami, FL)
- …assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. + Ensures employees are trained on ... Psychiatry and Pediatric Infectious Disease. + Work closely with Project Principal Investigator in adhering to Project regulations and legal changes. This list of… more