registerhilt.blogg.se - Regulatory medical writing

#REGULATORY MEDICAL WRITING UPDATE#

Utilized lean management tools (Lean Six-sigma and Improvement KATA) to promote efficiency and workload leveling.Managed multiple cross-functional projects to promote process improvements for manufacturing and QC.Successfully implemented a site-wide process improvement and planning tool (QC Stability SharePoint site) which ensured timely completion of project timelines and communicated study information.Facilitated Investigational Excellence (RCA) training for deviation investigators and mentored junior associates on quality system processes to ensure that investigations were conducted in a compliant and consistent manner.

#REGULATORY MEDICAL WRITING UPDATE#

Implemented change controls to enroll new materials, revise stability specifications, and update manufacturing parameters to improve processes.

Created and implemented CAPA plans, which included organizing necessary steps, timelines, and responsible areas, to address the deviation root cause and prevent recurrence.

Led investigations across all QC departments and manufacturing using root cause analysis (RCA) tools to identify the definitive root cause and/or contributing factors and assessed product impact for final batch disposition.

Participated in FDA, HHS, and internal audits by verifying that stability data for clinical trials, process validation, and commercial stability studies were accurately reported.

Authored, reviewed, and approved stability protocols and final stability reports for the seasonal and pandemic stability program.

Seqirus, Novartis Vaccines - Specialist and Analyst III

Coordinates resources for writers and technical editors between the global offices to ensure that project timelines are met.

Mentors junior writers and new employees on company best practices and client-specific documents.

Maintains a client-focused, collaborative work environment that fosters open communication between the client and internal teams.

Manages resources for projects in order to deliver the document within the project timeline and budget.

Provides quality control (QC) review of documents for internal and external consistency, visual appearance, and grammar in order to provide clients with a complete, accurate, and consistent document.Leads client teams through the document review process and conducts comment resolution meetings (CRMs) to address and align reviewers' comments.Cons of a Regulatory Medical Writing Career. Various types of education available: certificates, degrees and standalone courses. Might be able to freelance from a home office. Job opportunities should be good (15 employment growth from 2012-2022). Generally high level of job satisfaction. Ensures documents are compliant with regulatory guidelines, client specifications and templates, internal SOPs and style guides, and other guidance documents. Pros of a Regulatory Medical Writing Career.

Authors documents for submission to regulatory authorities including investigator's brochures (IBs), development safety update reports (DSURs), NDA summary documents (integrated summary of safety), briefing books and scientific advice, protocols, clinical study reports, and patient narratives.

Synchrogenix, A Certara Company - Regulatory Writer II