Medical Writing Coordinator
Proclinical is currently recruiting for a Medical Writing Coordinator with a leading pharmaceutical company in North Chicago, IL. Successful candidates will be responsible for formatting, proofing, and completion of Clinical Protocols, Clinical Study Reports, Investigator's Brochures, and other related clinical regulatory documents.
- Process, proofread, verify and manage various clinical regulatory documents, ensure they are submission-ready for publishing with an appropriate level of accuracy and consistency.
- Communicate regularly with colleagues and management regarding timelines and conflict to timelines for word processing requests, eSubmissions issues, and document completion dates.
- Provide ongoing support for Medical Writing, Clinical, and, other functional areas; act as a liaison between eDocs support and Medical Writing as needed.
- Responsible for effective communication among team members.
- Ensure 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.
- Ensure document styles and formatting are consistent with defined eSubmissions standards, so that documents created in MS Word are correctly rendered to PDFs.
- Confirm formats and styles are consistent with those in the clinical regulatory templates, when applicable.
- Populate document properties and ensure correct naming conventions are used per the eSubmissions System file naming conventions.
- Accurately and timely maintain document tracking for all documents.
- Ensure literature citations are correct. Perform literature searches. Maintain 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.
- Participate in process improvement activities.
Skills and Requirements:
- Bachelor of Science or Bachelor's degree in English or Communications
- Superior attention to details.
- High level computer skills.
- Excellent working knowledge of software programs in Windows environment (strong MS Word experience).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nadine Rucci at (+1) 215-531-5281 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.