Medical Writing Clinical Publisher

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

The primary responsibilities of the Medical Writing Clinical Publisher (Clinical Publisher) are to ensure the format and 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, and advanced Word processing skills (eg, macros, templates) as well as experience with the MS Office suite of products.
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.
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 as needed.
The Clinical Publisher will be on-the-job trained on Teva internal standard processes and systems involved with electronic document management.

Essential Duties & Responsibilities:

• Publishes clinical documents (with training and support)
• Document preparation skills and competence in Microsoft (MS) Word and Adobe Acrobat Professional
• Has a good understanding of processes and systems involved with publishing of GRMW clinical documents (with training and support)
• Performs administrative or other responsibilities with support
• Manages publishing of stand-alone documents and Clinical Study Reports (CSRs) with assistance
• Participates in meetings for CSRs and others as requested
• Participates in the preparation/revision of document templates, development of process, and preparation/revision of SOPs and 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
• Ability to work collaboratively or in a cross-functional capacity
• Advanced Word processing skills (e.g., use of custom MS Word templates and macros)
• Technical skills/tools

Preferred:

• 1- to 2 Years of experience related to clinical document publishing or regulatory submission publishing
• Knowledge of ICH/FDA/EU Health Authority guidelines (clinical documents and publishing) and regulations

Function

Sub Function

Reports To

Associate Director, GRMW Clinical Publishing Operations

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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.