Length of Assignment: 6 months contract to perm
Start Date: As soon as possible
Client: Our client is a multi-billion dollar company and a worldwide leader in the field of pharmaceutical and medical products. They are a research-based company who's purpose is to bring diagnostic and therapeutic innovations to the healthcare community with a commitment to advance patient care and to shape the future of medicine. Their focus lies in the areas of Women's Healthcare, Oncology, Diagnostic Imaging, and Neurology markets.
Position: The Medical Writing Specialist is responsible for tracking, quality control, and timely completion of the document components for complex medical writing projects, including Clinical Study Reports (CSRs), protocols, and other regulatory documents. This individual will not be writing the content of the submissions, but will review, edit and compile the components prior to publishing.
Responsibilities:
Work together with key interface partners (ex: Study Management, statistics, and Programming) to facilitate the completion of clinical study reports and their appendices.
Using project management skills to track, review and ensure timely completion of high quality regulatory documents
Ensure the study file components (ex: Investigator CVs, protocol and amendments, sample case report form) needed for CSRs are checked into the electronic archive on a timely basis and meet all global standards and regulatory requirements
Act as a resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintaining departmental and project-specific style guidelines to reflect new agreements and changes due to SOPs and regulatory guidelines
Assisting scientific medical writers in the review of protocols and case report forms to ensure that methods are clearly presented, data categories are clear, and terminology is consistent
Performing real-time edits to clinical documents during comment review and resolution meetings
Proofreading, reformatting and editing document text, as required, to ensure that all documents for a writing project meet all formatting and publishing requirements prior to final QC, compilation and electronic publishing
Managing the review and approval of documents in the document management system using standard procedures
Required Skills:
BS or AS degree
Strong electronic documentation and word processing skills
Excellent written and oral communication (English)
Excellent interpersonal skills
Familiarity with clinical research, statistics, and regulatory submission requirements
Understanding of regulatory guidelines (ICH, FDA, etc)
Experience in a Medical Writing group would be a plus!
This is a document formatting position, and 90% of it is formatting in
WordMust be an expert in
Word and formatting in
Word, no exceptions - should know all the ins and outs, can format, style, design templates, etc.
Document management system knowledge is important
Adobe experience is important
Med Writing experience would be extremely helpful
Contact:
Jessica Leveille
Manager, Biomedical Delivery Services at Orbis Clinical
Direct line (781) 496-3133
Direct fax (866) 855-5872
Email
[email protected]
100 Unicorn Park Drive
Woburn, MA 01801