Job Details
The primary responsibilities of the Medical Writing Clinical Publisher (Clinical Publisher) are to ensure the formatting quality of clinical documents including but not limited to clinical study protocols, clinical study reports, investigator's brochures, and summary modules for regulatory submissions. This position requires a methodical approach to document formatting, attention to detail, advanced Word processing skills (eg, macros, templates) as well as experience with the MS Office suite of products and profound knowledge of the in-house Electronic Document Management System (EDMS).
Clinical Publisher in Global Regulatory Medical Writing (GRMW) Operations provides support to GRMW (and other departments as appropriate) in the production of submission-ready clinical research documentation in support of drug development, product registrations, and product marketing. The Clinical Publisher's primary responsibility focuses on document publishing activities, but includes assignment to initiatives and or other tasks and projects as directed.
The Clinical Publisher is responsible for document formatting checks and ensures that GRMW documentation developed by medical writers adheres to applicable regulatory guidelines and departmental standards.
The Clinical Publisher will be on-the-job trained to leverage the master template and add-in toolbar to ensure consistency within documents prepared by medical writing or external partners. The Clinical Publisher will be able to advise and provide guidance to medical writers regarding formatting issues and document management in the official repository as needed.
The Clinical Publisher will be on-the-job trained on Client internal standard processes and systems involved with electronic document management.
Essential Duties & Responsibilities:
- Performs publishing/formatting checks on clinical documents
- Manages publishing of stand-alone documents and Clinical Study Reports (CSRs)
- Performs completeness checks and archival of supporting documents provided for publishing requests
- Document formatting requiring competence in Microsoft (MS) Word and Adobe Acrobat Professional and Plug-Ins
- Manages all documents level projects, smaller scale publishing projects and submissions with assistance
- Provides business support for Medical Writing systems such as Veeva, PleaseReview, In-house Word templates, SharePoint and others
- Provides template, style guide, PleaseReview and other supportive training and expertise to medical writers
- Has a good understanding of processes and systems involved with publishing of clinical documents
- Performs administrative or other responsibilities
- Participates in meetings for submissions and others as requested
- Participates in the preparation/revision of document templates, development of process, and preparation/revision of Standard Operating Procedures (SOPs) nd guidance documents
Qualifications
Required:
- Bachelor's degree in life sciences (or other related field)
- Excellent English, both written and spoken
- Strong attention to detail, clarity and accuracy
- dvanced Word processing skills (e.g., use of custom MS Word templates and macros)
- Significant editing skills and proficiency in the use of relevant software applications, and using templates and other electronic format
- Technical skills/tools
- Significant knowledge of government regulations pertaining to drug development and Regulatory submissions and understanding of the Company's products and SOPs
- bility to organize and present information, and to communicate GRMW processes and technical and editorial standards
- Excellent organizational/planning and problem-solving skills at the product and program level
Preferred:
- 2 Years of experience related to clinical document publishing or Regulatory submission publishing
- 2 Years of experience in the pharmaceutical industry with depth of knowledge related to the conduct of clinical trials and global Regulatory submissions
- Knowledge of ICH/FDA/EU guidelines (clinical documents and publishing) and regulations
- Experience with Veeva as EDMS