Document Control Specialist(formatting)

Job Description:

• The Medical Writing Word Processing Coordinator is responsible for formatting, proofing, and completion of Clinical Protocols, Clinical Study Reports, Investigator's Brochures, and other related clinical regulatory documents.
• Provides document formatting support to Medical Writing, Clinical, and, other functional areas, 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 eSubmissions standards so that the documents created in MS Word correctly render to PDFs.

Responsibilities/Qualifications:

• 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 eDocs 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.
• Accurately and timely maintains document tracking for all documents. Ensures literature citations are correct. Performs literature searches. 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.
• Bachelor of Science or Bachelor's degree in English or Communications will be considered. 2-5 years relevant pharmaceutical industry experience in a related area such as medical writing, quality, regulatory, clinical research, or product support/Research & Development desired.
• Medical Writing Word Processing Coordinator, is responsible for proficiently utilizing document authoring systems, templates, and tools to format MS Word documents and create submission-ready PDFs in accordance with Health Authority guidelines, and company policies and procedures in support of an electronic filing to a Health Authority. Receives project assignments from manager and has responsibility for independently managing projects. Reviews progress on projects with manager on a regular basis and provides direction on follow-up activities.

Responsibilities:

• Responsible for document formatting of Word documents using authoring templates and authoring systems/tools. Updates documents based on direction from Senior RA Doc Processing staff and manager
• Creates submission-ready Regulatory documents not auto-rendered in EDMS (e.g. for PDF source files, ensuring correct version of PDF, contains bookmark(s), inherit zoom, etc.)

• Performs document management tasks (e.g. importing/exporting documents into EDMS , entering metadata, routing for review/approval, etc.).
• Adapts to changes resulting from changing timelines, priority shifts, software updates, and changes in business processes.
• Prioritizes multiple tasks/projects with strong organizational skills and maintains effective interaction with RA professionals.
• Receives project assignments from manager but has responsibility for managing projects and timelines independently. Elevates issues to manager as appropriate in a timely manner.
• Tracks and reports departmental metrics for document specialist tasks. Identifies, suggests, and may assist in the implementation of process improvements.
• Acts as the recognized expert on the use of EDMS within RA.
• Trains/mentors new hires for compliance with Client SOPs, forms, checklists, and applicable regulatory requirements.

Qualifications:

• Required Education: High School diploma or equivalent and four years of related experience
• Preferred Education: Bachelor's degree
• Required Experience: Three years of pharmaceutical or industry related experience. Expert user of Word,
• Adobe, document management system, authoring tools
• Minimum 2 years' experience in managing or essential documents or equivalent
• Preferred Experience: Word processing knowledge and experience with Microsoft Office products (Word,
• Excel and PowerPoint)

Job Types: Full-time, Contract

Salary: $22.66 per hour

Benefits:

• 401(k)
• Dental insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• formatting/proofreading documents: 3 years (Preferred)
• Microsoft Office: 1 year (Preferred)

Work Location: One location