Medical Writing Word Processing Coordinator
 Spectraforce Technologies | |
 United States, Illinois, North Chicago | |
 Nov 15, 2024 | |
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Job Title: Medical Writing Word Processing Coordinator
Location: Remote Duration: 6 months (potential extension) We are open to fully remote candidates; candidates local to Lake County may be required to be onsite a certain number of days a week. It will be an initial 6 month contract with potential to extend. What hours and days will this person be working: Monday - Friday 8am CT-4:30pm CT (start and stop time is flexible 1 hour in either direction) Description: The Clinical Word Processing group provides specialized word processing services to clients across various functional areas in the company. The Senior Word Processing Coordinator is responsible for formatting regulated clinical documents to ensure they comply with company standards and strict industry requirements, importing documents into the Regulatory Information Management system (RIMS) [i.e., electronic document management system], ensuring documents have the correct RIMS metadata and properties assigned, and verifying that documents correctly render from Word to PDF in the system. Other responsibilities include providing RIMS business support, troubleshooting issues in Word, and bookmarking/hyperlinking PDFs in Adobe Pro. Must have: * Advanced Microsoft Word knowledge (e.g., TOC building, cross referencing, table formatting, and troubleshooting skills) Desired: * Knowledge of Adobe Pro, including bookmarking and hyperlinking * MS Word certification * Experience working in a document management system * Experience working with documentation in a regulated industry (e.g., pharmaceutical, legal, government) Description: The Senior Word Processing Coordinator II is responsible for formatting, proofing, and completion of clinical protocols, clinical study reports, investigator brochures, summaries, and other related clinical documents. Provides regulatory document formatting support to the Medical Writing, Clinical, and Pharmacovigilance Teams, ensuring successful preparation of high-quality submission-ready documents. Ensures completion of work to meet multiple client deadlines. Ensures styles and formatting are consistent with defined eSubmission standards so that the documents created in MS Word correctly render to PDF. Proofreads documents for accuracy and consistency. Coordinates and communicates with other word processing team members for consistency for all documents. Imports and routes documents in the submission system ensuring proper naming conventions and document properties. Responsibilities: Processes, proofreads, verifies and manages various clinical regulatory documents, ensuring they are submission-ready for publishing with an appropriate level of accuracy and consistency. Communicates regularly with colleagues and management regarding timelines and conflict to timelines for word processing requests, eSubmissions issues, and document completion dates. Provides ongoing support for Medical Writing, Clinical, and other functional areas; acts as a liaison between RIMS support and Medical Writing as needed. Responsible for effective communication among team members. Ensures all electronic document deliverables are processed and completed in alignment with timelines. Accountable for meeting the main objectives of assigned word processing projects within established timelines and with an appropriate quality level. Ensures document styles and formatting are consistent with defined eSubmissions standards, so that documents created in MS Word are correctly rendered to PDFs. Confirms formats and styles are consistent with those in the clinical regulatory templates, when applicable. Accountable for providing services and results on time, accurately and consistent with expectations. Populates document properties and ensures correct naming conventions are used per the eSubmissions System file naming conventions. Maintains knowledge of eSubmissions styles and formatting standards. Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards. Participates in process improvement activities. Qualifications: Bachelor of Science or Bachelor's degree in English or Communications will be considered. 5+ years relevant pharmaceutical industry experience in a related area such as medical writing, quality, regulatory, clinical research, or product support/Research & Development desired. What are the top 5 skills/requirements this person is required have? a. Required Skill 1: Computer literacy; proficient formatting skills in Microsoft Word b. Required Skill 2: independent learner; must be comfortable proactively asking questions c. Required Skill 3: proven ability in the strict application of standardized requirements (style guides, checklists, job aids, etc) d. Required Skill 4: proven ability to understand new technical concepts and extrapolate to new situations e. Required Skill 5: strong independent time management skills What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Proficiency in Adobe and ISI toolbox, experience working in a document management system; knowledge of Common Technical Document (CTD) format Other notable details about the environment from the hiring manager about this role. Job comprises continuous short term assignments (1-2 days) conducted in Word or Adobe, contractor is expected to complete assignments efficiently with minimal oversight (after initial training period). management/mentor aways available to provide guidance but due to the independent nature of the work, contractor must be comfortable with proactively asking questions. Computer literacy is essential. What positions/background experience do you feel are successful in this role Experience in the strict application of technical rules/requirements and/or following checklists. Technical roles. | |