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Requirement Process Documentation Designer
Ref No.: 14-01053
Location: Peepak, New Jersey
Start Date: 09/29/2014
Responsibilities:
Assist the procedural documentation designers/authors and Director Process Documentation to write, edit, proofread and format procedural documents for Pharmaceutical's safety and regulatory division
Responsibilities also include performing quality control checks for all documents produced for consistency and standards
Assisting process documentation designer with development, revision, and maintenance of specific activities, such as mapping process flows, form design, and document management in the electronic repository
Manage multiple writing projects in a complex and highly regulated environment
With input from subject matter experts, write and revise standard operating procedures (SOPs), work instructions, supporting documents, change requests and communications for safety and regulatory systems and processes
Provide support on mapping process flows, form design and document management in the electronic repository
Copyedit, proofread, and format documents for clarity and visual appeal while adhering strictly to both widely accepted (AMA, Chicago Manual) and internal style and editorial guidelines
Complete quality checks by following internal processes and established standards within timelines.
Interact with colleagues at multiple sites globally using Web collaboration software
Compare content across sections and other documents to ensure consistency of content, language and style
Reconcile and incorporate comments from multiple reviewers
Manage and maintain a database of hyperlinks and their usage
Upload documents to the corporate document management system, ensure accuracy of metadata, route documents for electronic approval and supervise document life cycles
Manage and maintain a database of active document revision projects, including their basic purpose, status and timelines

Requirements:

Excellent oral and written communication skills
Firm grasp of English grammar, usage, and style
Excellent interpersonal skills and an ability to diplomatically resolve differences between stakeholders from different business functions
Strong orientation to detail and ability to function and communicate issues to subject matter experts and direct manager
Familiarity with content management and collaboration tools such as SharePoint and Documentum
Minimum of five years of writing or copyediting experience in a regulated environment, e.g., medical or healthcare
Bachelor's degree in English, journalism (or related humanities field) and/or the life sciences
Desirable: Understanding of the drug development process and of the nature and goals of pharmacovigilance

Core and Technical Competencies:
Ability to work independently and prioritize multiple projects
Keen eye for detail and a track record of delivering high quality work with a minimum of errors
Demonstrated ability to adapt to changing situations and work well under pressure
Fluency in Microsoft Office applications, especially advanced MS Word functions such as styles, tracked changes, comparing and merging documents, section breaks, hyperlinks, tables of contents
Familiarity and comfort with databases such as MS Access, and an ability to learn new systems and processes quickly
Desirable: Familiarity with HTML and fundamentals of Web publishing
Desirable: Familiarity with MS Visio, MS PowerPoint, SnagIt and an aptitude for graphic design and clean visual presentation