Senior Specialist Quality and Publishing (m/f/x)

    CSL Behring
    King of prussia, PA
    Full-time, Part-time

    Job Description

    With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

    CSL is the parent company of CSL Behring and Seqirus. CSL Behringis a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

    We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

    Responsibilities

    Qualifications

    For our R&D department we are currently looking for a:

    Senior Specialist Quality and Publishing (m/f/x) - R-107278

    The Senior Quality and Publishing Specialist is a member of the Quality and Publishing team within the Medical Writing group. Under general supervision of the Quality and Publishing Manager, Senior Quality and Publishing Specialist works collaboratively with medical writers and is responsible for performing quality control (QC) review and publishing of clinical regulatory documents created by in-house or by medical writing vendors to produce high-quality documents. Senior Quality and Publishing Specialist ensures that documents adhere to internal and global quality standards and are in accordance with electronic publishing standards.

    What you can expect:
    • Perform QC review of Clinical Development deliverables created in-house or by medical writing vendors, including but not limited to protocols, investigator's brochures, clinical study reports, CTD summaries, and regulatory responses
      • Work collaboratively with medical writers and representatives from other functional areas to ensure that all source information / data are appropriately reported in terms of accuracy and completeness - and in accordance with project timelines
      • Verify data against source documents
      • Assess document to ensure internal consistency, consistency between related documents, formatting, hyperlink functionality, spelling, grammar, syntax, lexicon are in accordance with agreed upon internal and external quality standards
      • Assist with vendor management and performance assessment relating to QC process
    • Perform compilation, integration, rendering, and publishing submission documents
      • Ensure that documents provided to Regulatory are submission-ready and comply with internal and external (global) electronic publishing standards
      • Perform technical QC review (electronic functionality, adherence to internal and external publishing standards)
      • Act as a central resource for staff across all sites on document format and publishing-related issues
      • Provide formatting and publishing support to medical writers and other functional groups
    • Contribute to development, maintenance, and implementation of medical writing best practices in relation to document standards, templates and publishing
    • Assist in document timelines / resource planning within the clinical teams
    • Support senior staff with prospective resourcing and budgeting
    Additional experience requirements:
    • Advanced knowledge of document formatting, editing, and publishing techniques and tools. Expert working knowledge of Adobe Acrobat and Microsoft Word is essential; knowledge of ISI Toolbox is an advantage
    • Familiarity with QC review principles and processes, and the AMA Manual of Style
    • Experience in the preparation of documents for submission using Regulatory / Electronic Document Management Systems e.g. Documentum
    • Familiarity with the requirements for publishing clinical study reports
    • Demonstrate ability to multi-task in a fast pace environment under strict timelines
    What you bring:
    • Bachelor degree, or equivalent in Science-related discipline
    • 4-5 years' experience of working within the CRO/Pharma/Biotech industry
    • Excellent level of English language proficiency
    • Expert MS Office skills
    #Behring

    Capabilities

    Worker Type:

    Employee

    Worker Sub Type:

    Regular

    Posting ID: 556643914Posted: 2020-05-21