Industry: Healthcare - Allied Health - Social Worker/Counselor
Type: Full Time
$52,985.00 - 80,970.00
Implements selected activities (such as document workflows, tracking, and electronic QC) associated with electronic document-related activities for regulatory documents. Communicates deliverables, electronic document process, and durations associated with these activities to the Medical Writing Manager, Clinical Project Management, and other functional areas such as Publishing, etc., as required.
Ensures all electronic document deliverables are processed and compiled in alignment with timelines. Manages workflows for review/approval in eSubmission system.
Coordinates, tracks completion, and manages acceptance of casebooks and appendix documents. Manages eDoc tracking spreadsheet.
Prepares documents for submission to RIC, Data Management, and Regulatory Affairs. Manages process and performs electronic QC of casebooks and appendices.
Confirms completeness of information in appendix documents (e.g. CSR).
Acts as interface to resolve issues associated with casebooks and appendices through ongoing communication with the clinical team. Maintains strong knowledge of casebook and appendices organization and content.
Compiles and organizes literature references for regulatory documents. Performs literature searches.
Acts as eDocs Peer Advisor/Subject Matter Expert for assigned clinical teams. Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards. Responsible for effective communication among team members. Holds team members accountable to agreed-upon deliverables and dates.
Coaches and mentors more junior Medical Writing Coordinators. Participates in process improvement activities.
Serves as an expert on the electronic document system in support of the clinical team. Serves as subject matter expert on cross-functional teams supporting the implementation of new regulatory initiatives impacting the compilation of CSRs (i.e. eCTD) .
Bachelor of Arts or Bachelor of Science or Associates Degree preferred; equivalent experience considered.
2-3+ years in clinical research or related field.
Strong knowledge of organization and content of clinical documents.
Strong knowledge and experience with CTD content templates.
Excellent written and oral communication skills.
Superior attention to detail.
High level computer skills. Proficient in electronic document management system. Excellent working knowledge of software programs in Windows environment.
Experience in working with collaborative, cross-functional teams .