Duration: 12 months contract
Job Description:
The Medical Writing Operations Formatter provides document formatting and Clinical Study Report (CSR) Appendix support for clinical and regulatory documents. This role partners closely with Medical Writers and cross-functional stakeholders to ensure documents meet established formatting standards, regulatory requirements, and project timelines. The formatter is responsible for formatting, reviewing, and maintaining high-quality submission-ready documents and supporting CSR Appendix coordination activities within Regulatory Information Management Systems (RIMS).
Key Responsibilities:
- Defines scope of formatting, or Clinical Study Reports (CSR) Appendices activities with the document author.
- Format, import and route documents in the regulatory information management systems (RIMS).
- Ensure document format and styles are consistent with the defined in RIMS and are consistent with the clinical and regulatory templates.
- Ensure document properties and naming conventions are used.
- Maintain strong knowledge of RIMS styes and formatting standards.
- Ensures all documents are published in RIMS and meet required timelines.
- Ensure completeness of information in CSR Appendices.
- Maintain strong knowledge of CSR/CSR appendices organization and content and knowledge of CTD structure.
- Contributes to the development, implementation, and maintenance of medical writing operations business processes.
- Acts as subject matter expert (SME) for the master file system and formatting, report publishing, or Clinical Study Reports (CSR) Appendices to the medical writing stakeholders.
- Effectively communicates deliverables needed to stakeholders.
- Must demonstrate good interpersonal and organizational communication skills, including conflict management skills.
- Assists in the management of the centralized mailbox.
- Tracks and maintains metrics and assists in the preparation and maintenance of training documents.
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 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.
Qualifications:
- Bachelor of Science or Bachelor's degree in English or Communications will be considered.
- 3 to 5 years of relevant pharmaceutical industry experience in a related area such as medical writing, quality, regulatory, clinical research, or product support/Research & Development desired.
1. About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .
2. Equal Employment Opportunity (EEO) Statement:
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
3. AI Statement:
By applying, you acknowledge that AI-assisted tools may be used during hiring.
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