Medical Writing Editor

Medical Writing Bratislava, Petr┼żalka


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.

We're looking for a talented Medical Writing Editor to join our team in Bratislava, Slovakia either office or remote based.

Based on company and personal performance, there is a career path to follow to become a fully fledged Medical Writer should this be desired.

The Medical Writing Editor analyzes data that requires a review of a variety of factors. This position is responsible for providing advanced technical writing and editing support. Reviews various regulatory and clinical research technical documents, including protocols, clinical study reports, informed consent forms, investigator brochures, and other regulatory documents. Copyeditor duties are focused on proofreading documents for text, content, and syntax consistency so as to help facilitate the successful production and completion of such deliverables in a professional and polished manner. Provides communication support between medical writers, internal personnel, and clinical research clients. Provides internal quality control (QC) review of documents as well as document finalization. Performs literature and reference research activities to support medical writers and regulatory professionals. Assists in the training and mentoring of more junior members of the team.

What you'll be doing:

  • Reviews, proofreads, edits, updates, corrects, formats, and makes improvement suggestions for project-related clinical study materials
  • Assists in the writing of informed consent documents and shell CSRs
  • Ensures timelines are promptly met
  • Develops and supports a review cycle process for medical writing templates, as needed
  • Takes the initiative to be proactive and search out tasks before they are given
  • Reviews material for grammar, spelling, punctuation, correct medical terminology, typographical errors, and formatting
  • Checks accuracy of content and ensures style consistency
  • Verifies data against original sources for quality control
  • Verifies correct implementation of client and regulatory changes
  • Liaises with various departments, including Medical Affairs, Biostatistics, and Project Management, to ensure timelines are met and document quality control reviews are completed
  • Creates in-text tables for clinical study reports and inserts hyperlinks/bookmarks as needed
  • Prepares clinical study reports and related regulatory documents for finalization in accordance with eCTD guidance and FDA PDF specifications
  • Performs data/content verification and reference checks information as required
  • Adheres to AMA style guidelines
  • Ensures client specifications are completed successfully and medical writing documents are stored or archived appropriately
  • Assists medical writing team with client-related services as necessary
  • Participates in corporate initiatives and actions that ensure the continued success of the company
  • Maintains familiarity with literature search techniques
  • Maintains working knowledge of applicable industry guidelines and regulations
  • Maintains working knowledge of, reviews, and updates departmental standard operating procedures, associated documents, and working guidelines as required
  • Adheres to required Premier Research training plan
  • Other activities as designated

You'll need this to be considered:

  • Bachelor's degree or its international equivalent from an accredited institution.
  • Scientific/technical background preferred
  • Previous related experience (clinical trials, publishing, writing, or editing)
  • Previous medical editing experience in a regulated environment, preferably in the pharma/biotech/CRO sector
  • Expert in Microsoft Office and Adobe Acrobat
  • Prior experience using technical software
  • Prior experience with training and mentoring staff preferred
  • Working knowledge of ICH and FDA Guidance Documents/EU Directives/ISO14155 regulations and/or drug/device development
  • Strong knowledge of AMA style guidelines
  • Strong analytical skills and knowledge of both medical and industry terminology
  • Must be able to read for clarity, logic, contradictory statements, and missing material
  • Demonstrated mastery of grammar, punctuation and spelling
  • Ability to express ideas logically, clearly and concisely and provide feedback in a tactful way
  • Demonstrated professional expertise with ability to exercise judgment within defined procedures and practices to determine appropriate action
  • Ability to use company policies and procedures to resolve a variety of issues
  • Builds productive internal/external working relationships
  • Excellent typing skills, ability to use and modify templates, and ability to create and manage large and complex electronic files and documents
  • Effectively plans, schedules, and coordinates writing assignments
  • Fluent verbal and written English
  • Collaborative, accountable, and dependable, with a strong commitment to quality
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities
  • Must be able to communicate effectively, work in a remote or virtual work/office environment as applicable, and respect global time differences
  • Strong verbal and written communication skills
  • Excellent organizational and time-management skills; able to prioritize work to meet deadlines
  • Maintains a positive, results-orientated work environment
  • Able to perform tasks with general instructions on routine work

#LI-JD1