The Fountain Group

The Fountain Group
is a national staffing firm and we are currently seeking a
--------Medical Writing Operations Formatter
for a prominent client of ours. This position is in
REMOTE.
Details for the position are as follows:
Medical Writing Operations Formatter
Location:
Remote (U.S.)
Pay Rate:
$33-$35/hour
Contract Duration:
12 Months
Industry:
Pharmaceutical / Biotechnology
Position Overview
We are seeking a detail-oriented
Medical Writing Operations Formatter
to support the preparation, formatting, and publishing of clinical and regulatory documentation within the pharmaceutical industry.
This position works closely with Medical Writers, Clinical Research, Regulatory Affairs, and other cross-functional teams to ensure documents meet established formatting standards, regulatory submission requirements, and project deadlines.
The ideal candidate will have experience with
clinical and regulatory document formatting, Clinical Study Reports (CSRs), CSR Appendices, Microsoft Word, and Regulatory Information Management Systems (RIMS).
Key Responsibilities
<ul>
<li>Format, proofread, review, and prepare clinical and regulatory documents to ensure accuracy, consistency, and submission readiness.</li>
<li>Support the preparation, organization, and completeness of Clinical Study Reports (CSRs) and CSR Appendices.</li>
<li>Import, format, route, track, and publish documents within Regulatory Information Management Systems (RIMS).</li>
<li>Ensure documents comply with established clinical and regulatory templates, formatting standards, and electronic submission (eSubmission) requirements.</li>
<li>Apply appropriate document styles, formatting, properties, and naming conventions to ensure consistency across regulatory submissions.</li>
<li>Ensure Microsoft Word documents are properly formatted and accurately rendered into PDFs for electronic submission.</li>
<li>Maintain knowledge of Common Technical Document (CTD) structure, CSR organization, regulatory publishing requirements, and industry formatting standards.</li>
<li>Collaborate with Medical Writers and document authors to define formatting requirements, deliverables, and project timelines.</li>
<li>Coordinate with cross-functional stakeholders to resolve document formatting issues, publishing challenges, and competing priorities.</li>
<li>Serve as a subject matter expert (SME) for document formatting, regulatory publishing processes, master file systems, and CSR Appendix preparation.</li>
<li>Verify literature citations, conduct literature searches as needed, and ensure document accuracy.</li>
<li>Maintain accurate document tracking, metrics, and status updates to support timely completion of deliverables.</li>
<li>Assist with centralized mailbox management, training documentation, and continuous process improvement initiatives.</li>
<li>Support the development, implementation, and maintenance of medical writing operations procedures and best practices.</li>
</ul>
Qualifications
Education
<ul>
<li>Bachelor's degree required or preferred in a relevant field, including Science, English, Communications, or a related discipline.</li>
</ul>
Experience
<ul>
<li>3-5 years of relevant experience within the pharmaceutical, biotechnology, clinical research, regulatory affairs, medical writing, or related industry.</li>
<li>Experience formatting and processing clinical or regulatory documents for electronic submission.</li>
<li>Familiarity with Clinical Study Reports (CSRs), CSR Appendices, and regulatory documentation requirements.</li>
<li>Experience working with Regulatory Information Management Systems (RIMS) or electronic document management systems.</li>
<li>Knowledge of regulatory submission standards, document publishing processes, and CTD structure.</li>
</ul>
Technical Skills
<ul>
<li>Strong proficiency in Microsoft Word, including advanced formatting, styles, templates, headers/footers, tables, and document layout.</li>
<li>Experience preparing documents for PDF conversion and electronic regulatory submissions.</li>
<li>Familiarity with RIMS, eSubmissions systems, and document management platforms.</li>
<li>Ability to maintain document properties, naming conventions, and version control.</li>
<li>Strong proofreading, quality control, and document review skills.</li>
</ul>
Preferred Qualifications
<ul>
<li>Previous experience supporting Medical Writing Operations or Regulatory Publishing teams.</li>
<li>Hands-on experience preparing or coordinating CSR Appendices.</li>
<li>Familiarity with pharmaceutical regulatory submissions and clinical development documentation.</li>
<li>Experience with regulatory document management platforms such as Veeva Vault RIM or similar systems.</li>
<li>Experience developing or maintaining standard operating procedures (SOPs), document templates, or training materials.</li>
</ul>
Additional Skills
<ul>
<li>Exceptional attention to detail and commitment to document quality.</li>
<li>Strong organizational, time management, and multitasking abilities.</li>
<li>Excellent written and verbal communication skills.</li>
<li>Ability to manage competing deadlines in a fast-paced, deadline-driven environment.</li>
<li>Strong collaboration, problem-solving, and stakeholder management skills.</li>
<li>Ability to work independently and effectively in a remote environment.</li>
</ul>
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Medical Writing Word Processing Coordinator II

Medical Writing Word Processing Coordinator II

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