Apply to Medical Writer, Associate Professor, Managing Editor and more. Lead clinical trial protocol development process with CPO/Region representative (Medical Advisor, statistician, regulatory. 15 Entry Level Creative jobs available in Port Saint Lucie, FL on Indeed.Maintain broad awareness of developments in relevant therapeutic areas to ensure scientific and clinical relevance of written materials in specific project activities.Comply with established company policies and procedures, and industry and regulatory guidelines.Demonstrated ability to work both independently and in team environments with minimal supervision.Interact with internal and external authors (as needed) and key stakeholders to develop high‑quality documents.Interpret statistical and clinical data with appropriate guidance/direction from teams and management.Write, review, and edit clinical regulatory documents such as clinical study protocols, clinical study reports (CSRs), Investigator’s Brochures, and other documents as required for submissions.Documenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, ) by filling out and collecting signatures on group training forms as required.Stays current on medical writing best practices and regulatory guidelines.Develops, edits and reviews regulatory documents within agreed timelines that have high quality scientific content, organization, clarity, accuracy, format and consistency.Represents Medical Writing and Clinical Biometrics on cross-functional teams.Manages all aspects of the medical writing processes for document development including, quality check, scheduling/timeline management, driving document preparation, coordinating document reviews and revisions, maintaining version control, and coordinating final reviews and approval.Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers.Understands, assimilates, and productively interprets sources of information, with appropriate guidance/direction from product teams and/or authors. Knowledgeable of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions.
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