Medical Writing Editor

Premier Research Group Limited
02 Dec 2017
08 Dec 2017
Contract Type
Full Time
Premier Research helps highly innovative biotech and specialty pharmaceutical companies transform life-changing ideas into reality.

We're looking for a talented Medical Writing Editor to join our team! This role can be offered in any of our EU locations where we have an office presence. Dependent on experience level, we may consider home based candidates.

The successful job holder will be responsible for technical writing and editing support, reviewing various regulatory and clinical research technical documents. Additionally, you will have copy editor duties focused on proofreading documents for text, content, and syntax consistency and will help to provide internal QC review of documents as well as document finalization. Literature and reference research activities to support medical writers and regulatory professionals will also be a responsibility of this role.

The Medical Writing Editor:

- Ensures timelines are met promptly
- Is responsible for providing editing, formatting, and general assistance to members of the medical writing team
- Drives the compilation of documents into a final product
- Takes the initiative to be proactive and search out tasks before they are given

- Liaises with various departments, including medical writing, regulatory, pharmacokinetics, etc
- Works within these various departments to facilitate timelines are met and document quality control reviews are completed
- Provides general editing assistance (eg, grammar, punctuation, spelling, formatting) and quality control checks for clinical study reports (shell and draft), appendices, and tables and figures (Section 14)
- 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.
- Audits study files for SOP compliance
- Ensures client specifications are completed successfully and medical writing documents are stored or archived appropriately
- Mentors colleagues for compliance with FDA and Premier guidance
- Provides a variety of technical skills, especially in programs such as Microsoft Office and Adobe Acrobat
- Maintains and develops document templates
- Maintains working knowledge of departmental standard operating procedures and FDA/ICH guidelines
- Reviews and updates the standard operating procedures, associated documents, and working guidelines as required
- Maintains familiarity with literature search techniques
- Other activities as designated

- Undergraduate degree (BA/BS) or its international equivalent from an accredited institution (Scientific/technical background preferred)
- Ideally some related experience (clinical trials, publishing, writing or editing)
- Expert in Microsoft Office and Adobe Acrobat
- Requires excellent typing skills, ability to use and modify templates, and ability to create and manage large electronic files and documents
- Requires analytical skills and a working knowledge of medical terminology
- Effectively plans, schedules and coordinates writing assignments
- Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations and/or drug/device development
- Knowledge of web based communication tools and various technical programs
- Knowledge of AMA style guidelines