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    Medical Writing Word Processing Coordinator

    Spectraforce Technologies
    1+ years
    Not Disclosed
    Chicago
    10 Nov. 18, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Medical Writing Word Processing Coordinator

    Location: Remote (with potential onsite requirements for Lake County-based candidates)

    Duration: 6-month Contract (with potential for extension)

    Work Schedule: Monday - Friday, 8:00 AM CT - 4:30 PM CT (with 1-hour flexible start and stop time)

    Description:

    The Senior Medical Writing Word Processing Coordinator will support a Clinical Word Processing group, providing specialized services to clients in the pharmaceutical industry. This role focuses on ensuring the accurate formatting and submission-ready status of regulated clinical documents. The position will involve working with various medical writing teams, ensuring consistency in document formatting and adherence to strict industry and regulatory standards. The coordinator will troubleshoot issues in Microsoft Word, work within a regulatory information management system (RIMS), and ensure all documents properly render from Word to PDF.

    Key Responsibilities:

    • Format, proofread, and manage clinical regulatory documents, ensuring they are ready for submission with accuracy and consistency.
    • Support medical writing, clinical, and pharmacovigilance teams in preparing high-quality submission-ready documents.
    • Ensure all documents adhere to defined eSubmission standards for proper rendering in PDF format.
    • Communicate regularly with team members and management regarding timelines, conflicts, and document completion.
    • Import and route documents within RIMS, ensuring correct metadata and document properties.
    • Maintain ongoing knowledge of eSubmission and regulatory document standards and train on any required updates.

    Qualifications:

    • Bachelor’s degree (preferably in English, Communications, or a related field).
    • 5+ years of relevant experience in the pharmaceutical industry (medical writing, regulatory, clinical research, etc.).

    Top 5 Required Skills:

    1. Proficiency in Microsoft Word formatting (TOC building, cross-referencing, table formatting).
    2. Ability to work independently and proactively ask questions when needed.
    3. Strong application of standardized formatting and style guides.
    4. Ability to grasp new technical concepts and apply them effectively.
    5. Excellent time management skills and ability to work under minimal supervision.

    Nice-to-Have Skills:

    • Proficiency in Adobe Pro, ISI toolbox, and experience working with document management systems.
    • Knowledge of the Common Technical Document (CTD) format.

    Work Environment:

    • This role involves completing short-term assignments (1-2 days) and requires the contractor to work efficiently with minimal oversight after the training period. Management and mentors will be available to provide guidance, but the role demands an independent, self-driven approach to work.

    Successful Backgrounds:

    • Candidates with experience in technical roles, particularly in applying strict technical requirements and following detailed checklists, will be successful in this position.

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