Medical Writing Word Processing Coordinator

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).

• 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.

• 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.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities