To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $28 to $33 an hour.

Client Industry: Pharmaceutical

Job Mode: 100% Remote

Contract Duration: 12 Months Contract, with potential extension based on performance and business

Job Summary:

The Medical Writing Word Processing Coordinator supports the formatting, quality review, and publishing of clinical and regulatory documents for regulatory submissions. The role focuses on Clinical Study Reports and CSR appendices, ensuring document accuracy, completeness, and consistency with established regulatory standards. The position collaborates with Medical Writers and cross functional stakeholders to deliver submission ready documents within project timelines. Responsibilities also include document management through regulatory information management systems, process improvement, and operational tracking.

Key Responsibilities:

• Format, proofread, verify, and publish clinical and regulatory documents in accordance with established submission standards.
• Import and route documents through regulatory information management systems and electronic document management platforms.
• Ensure consistent document styles, formatting, templates, properties, and file naming conventions.
• Verify that Word documents render correctly into submission ready PDF files.
• Review Clinical Study Report appendices for completeness, accuracy, and consistency with the required structure.
• Maintain knowledge of Clinical Study Report organization, Common Technical Document structure, and regulatory formatting standards.
• Verify literature citations and conduct literature searches as required.
• Track document deliverables, completion dates, metrics, and submission timelines.
• Coordinate with Medical Writing, Clinical, Regulatory, and document support teams to resolve issues and communicate timeline risks.
• Support centralized mailbox management, training documentation, and continuous process improvement initiatives.

Required Qualifications:

• Bachelor degree in Science, English, Communications, or a related field.
• 3 to 5 years of relevant pharmaceutical industry experience in medical writing, regulatory affairs, clinical research, quality, or research and development support.
• Strong Word formatting, proofreading, and document quality control skills.
• Knowledge of clinical and regulatory document templates, electronic submissions, and regulatory formatting standards.
• Understanding of Clinical Study Reports, CSR appendices, and Common Technical Document structure.
• Strong attention to detail, organizational skills, and cross functional communication abilities.

Preferred Qualifications:

• Experience with regulatory information management systems or electronic submission platforms.
• Experience with document publishing, report formatting, or CSR appendix coordination.
• Knowledge of regulatory submission standards and electronic publishing requirements.
• Experience maintaining standard operating procedures, training materials, and operational metrics.
• Experience with literature reference management and citation verification.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)