Job description

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.

Please Look for direct experience

Formatting Regulartory documents in MS Word

- Regulartory operations
- submission Operations
- document processing
- Submission readiness

Summary:

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:

• Proofreads documents for accuracy and consistency. Coordinates and communicates with other word processing team members for consistency for all documents.
• Ensures completion of work to meet multiple client deadlines.
• 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 styles and formatting are consistent with defined eSubmission standards so that the documents created in MS Word correctly render to PDF.
• Imports and routes documents in the submission system ensuring proper naming conventions and document properties.

Responsibilities:

• Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards.
• Populates document properties and ensures correct naming conventions are used per the eSubmissions System file naming conventions.
• Confirms formats and styles are consistent with those in the clinical regulatory templates, when applicable.
• Accountable for meeting the main objectives of assigned word processing projects within established timelines and with an appropriate quality level.
• Provides ongoing support for Medical Writing, Clinical, and other functional areas; acts as a liaison between eDocs support and Medical Writing as needed.
• 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.
• Responsible for effective communication among team members. Ensures all electronic document deliverables are processed and completed in alignment with timelines.
• Ensures document styles and formatting are consistent with defined eSubmissions standards, so that documents created in MS Word are correctly rendered to PDFs.
• Accountable for providing services and results on time, accurately and consistent with expectations.
• Maintains knowledge of eSubmissions styles and formatting 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.

Open to bringing someone in at the coordinator I or II levels (1+ years, 2+ years) – Pay rates will reflect level I or level II.

Intake Notes

1) 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)

2) 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

3) 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

4) 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.

5) 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.

Job Type: Contract

Salary: $13.71 - $39.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Regulatory Document formatting: 4 years (Preferred)
• regulatory submission documents review: 4 years (Preferred)
• MS word: 4 years (Preferred)
• document processing: 4 years (Preferred)
• submission Operations: 4 years (Preferred)

Work Location: Remote

caravetterealestate.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, caravetterealestate.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, caravetterealestate.com is the ideal place to find your next job.