Medical Writing Clinical Publisher

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The primary responsibilities of the Clinical Publisher (Clinical Publisher) are to ensure the accuracy and compliance 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 prior experience in clinical document publishing or regulatory submission publishing, advanced technical proficiency with Microsoft Word and Adobe Acrobat, and a strong understanding of global regulatory submission standards (ICH, FDA, EMA).

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 documents in support of drug development, product registrations, and product marketing. The Clinical Publisher's responsibility includes assignment to initiatives and or other tasks and projects as directed. These may include:

• Formatting checks of documents and ensures that GRMW documentation developed by Medical Writers adheres to applicable regulatory guidelines and departmental standards.
• Leveraging 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 as needed.
• Training on Teva internal standard processes and systems involved with electronic document management.

 

Work format: This position offers flexibility for remote work. However, a hybrid arrangement in our Parsippany, NJ or West Chester, PA offices is preferred to facilitate cross-functional collaboration.

How you’ll spend your day

• Publishes clinical and regulatory documents (protocols, IBs, DSURs, CSRs, summary documents, and others) in compliance with regulatory guidelines and internal SOPs
• Ensures submission readiness of all clinical documentation through thorough technical QC (document navigation, hyperlinking, bookmarks, headers/footers, metadata, PDF compliance, etc.)Checks document formatting to ensure consistency, accuracy, and adherence to corporate style guides and regulatory publishing standards.
• Manages publishing 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 cross-functional submission planning meetings and collaborates closely with Regulatory Operations and Medical Writing teams to ensure alignment and efficiency Contributes to process optimization, including template maintenance, development of process, and preparation/revision of SOPs and guidance documents

Your experience and qualifications

• Bachelor’s degree in life sciences (or other related field)
• Minimum of 2 years of experience in clinical document publishing or regulatory operations publishing within the pharmaceutical or biotech industry.
• Working knowledge of ICH, FDA, and EMA requirements related to clinical documentation, global submission processes (e.g., IND, NDA, MAA) and eCTD submissions.
• Excellent English, both written and spoken
• Excellent attention to detail, organization, and communication skills.
• Advanced proficiency in Microsoft Word (macros, templates, and complex formatting) and Adobe Acrobat Professional (including publishing plug-ins and validation tools).
• Excellent organizational/planning and problem-solving skills at the product and program level