Medical Writing Coordinator Position Description
- The Medical Writing Coordinator is responsible for providing regulatory document support to the medical writing teams, ensuring successful preparation of high quality submission-ready documents. Provides expertise in the management and coordination of casebooks and other CSR Appendix 16 documents ensuring timely completion, completeness, and formatting accuracy. Assists in the compilation of literature references and ensures delivery into the electronic submission system. May participates in process improvement activities.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Develops strong knowledge of casebook and CSR appendices organization and content.
- Coordinates, tracks completion, and manages acceptance of casebooks and CSR appendix documents. Manages eDOC tracking spreadsheet.
- Prepares documents for submission to RIC, Data Management, and Regulatory Affairs. Manages process, confirms completeness, and performs electronic review/QC of
- casebooks and CSR appendices. Manages workflows for review/approval in eSubmission system.
- 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, RIC, etc., as required.
- Acts as interface to resolve issues associated with casebooks and CSR appendices through ongoing communication with the clinical team.
- Compiles and organizes literature references for regulatory documents. Performs literature searches.
- Ensures all electronic document deliverables are processed and compiled in alignment with timelines.
- Participates in process improvement activities.
- Bachelor of Arts or Bachelor of Science or Associates Degree preferred; equivalent experience considered.
- Minimum Experience:
- 1-3+ yrs in clinical research or related field.
- Knowledge of organization and content of clinical documents.
- Knowledge and experience with Common Technical Document requirements/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.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.