Publisher jobs in United States, Pennsylvania, East Bradford Township

A Clinical Publisher in Global Regulatory Medical Writing (GRMW) Operations provides basic 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 formatting documents and ensures that GRMW documentation developed by Medical Writers adheres to applicable regulatory guidelines and departmental standards.

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Publishes clinical documents (protocols, IBs, DSURs, CSRs, summary documents, and others)
• Manages preparation of stand-alone documents and Clinical Study Reports (CSRs)
• 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, 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 GRMW 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 SOPs and guidance documents

Required:

• Bachelor’s degree in life sciences (or other related field)
• Excellent English, both written and spoken
• Strong attention to detail, clarity and accuracy
• Significant editing skills and proficiency in the use of relevant software applications, and using templates and other electronic formats
• Advanced Word processing skills (e.g., use of custom MS Word templates and macros)
• Advanced knowledge of Adobe Acrobat Professional and Plug-Ins

Technical skills

• Significant knowledge of government regulations pertaining to drug development and understanding of the Company’s products and Standard Operating Procedures (SOPs)
• Ability 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 submissions
• Experience with Veeva as EDMS
• Knowledge of ICH/FDA/EU guidelines (clinical documents and publishing) and regulations

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.