Clinical Publisher

The primary responsibilities of this position are to ensure the highest quality of clinical documents including but not limited to clinical study protocols (CSPs), clinical study reports (CSRs), investigator’s brochures (IBs), and summary modules for regulatory submissions. This position requires a methodical approach to document review, attention to detail, an understanding of industry guidelines for regulatory submissions, and advanced word processing skills (eg, macros, templates) as well as experience with the MS Office suite of products.

Responsibilities:

• Responsible for ensuring clinical documents developed within the Medical Writing group meet the quality standards established for regulatory submissions including the integrity of the content relative to the source information/data, consistency of messaging, and compliance with submission-ready standards and processes within the defined timelines.
• Manage report level publishing activities for clinical documents across therapeutic areas. Ensures the lifecycle management of the clinical documents is maintained appropriately within the electronic document management system.
• Evaluate trends emerging from the quality control findings and recommends process improvements, training, or other measures. Ability to perform the role of an editor as needed. In addition, may be responsible for budget and resource allocation pertaining to outsourced editing and publishing activities.
• Act as a central resource on all medical writing and regulatory publishing issues to ensure consistency within documents prepared by medical writing or external partners.
• Serve as expert regarding the master template and add-in toolbar that defines proper formatting for all document templates; advise and provide high-level guidance to the Template Working Group regarding formatting issues as needed.
• Responsible for formatting and proof-reading documents to conform with domestic and/or international regulatory submission and internal document standards
• Independently formats in-text tables and graphs to meet standards for electronic regulatory submissions. Documents include, but are not limited to, clinical study reports (CSRs), clinical study protocols or amendments, investigator brochures (IBs), development safety update reports (DSURs) and other safety/pharmacovigilance documents, and various sections of New Drug Application (NDA) and Investigational New Drug (IND) submissions.
• Formats Microsoft Word documents using defined styles, corporate/and partner-company templates, and document style guide
• Performs quality checks to ensure accuracy of near-final documentation and confirm functionality of final output (Acrobat bookmarks, internal hyperlinks, etc.)
• Provide input into appropriate standards, process and technology projects for major submission activities as well as co-leads submission activities.
• Worked with project teams to maximize the use and value of document templates and developed document formatting standards.
• Resolved publishing issues to ensure on-time and quality submissions.
• Involved in Bookmarking and Hyperlinking of scanned legacy documents.
• Experience in both Electronic and Paper submissions as well as Publishing Reports.
• Published (Bookmark and Hyperlink) Clinical Protocols and Study Reports, work with other peers to QC Bookmarks and Hyperlinks prior to finalization.
• Responsible for checking various logs and ensure documents are produced in accordance with department procedures and in accordance with companies’ SOPs.
• Worked with functional areas to identify legacy documents to be migrated into an electronic document management system.
• Performed review of clinical submission documents to ensure compliance with FDA and ICH guidelines and internal standards.

Qualifications:

• Bachelor’s degree required
• A minimum of 5-6 years of Clinical or Regulatory Publishing experience in the biotechnology or pharmaceutical industry required
• Familiarity with style rules from the American Medical Association (AMA) Manual of Style required
• Understanding of regulatory submission requirements and ICH guidelines (including E3 and E6) necessary
• Familiarity with drug development necessary, including the various trial phases and processes used within a clinical development environment from protocol design through regulatory submission
• Ability to organize and synthesize large amounts of information required
• Excellent communication skills (verbal and written) required
• Strong attention to detail, clarity, and accuracy necessary
• Ability to work collaboratively or in a cross-functional capacity required
• Advanced word processing skills preferred (e.g., use of custom MS Word templates and macros)

Technical Skills/Tools:

• Management System:Insight Manager 5.1 & currently working on 6.1 upgrade
• Regulatory Publishing:Insight Publisher ,eCTDXpress ,Octagon Viewpoint, ISIToolbox 6.0, eCTDViewer
• DMS:Documentum, FirstDocs, Opentext Livelink, Veeva Vault
• Authoring Tools:MS Word, ISIWriter, Starting Point Templates
• Other Tools:Microsoft Office, Visio, MS Project, PleaseReview

Offer:

• A competitive salary package with benefits
• A work environment in a human-sized, dynamic, rapidly growing biotech company