Process Documentation Designer

Write, edit, proofread and format safety and regulatory procedural documents. Perform quality control checks for all documents produced for consistency and standards. Assist process documentation designer with development, revision, and maintenance of specific activities. Manage multiple writing projects in a complex and highly regulated environment.

PRIMARY RESPONSIBILITIES

- 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

SKILLS:

TECHNICAL SKILL 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

QUALIFICATIONS (IE, PREFERRED EDUCATION, EXPERIENCE, ATTRIBUTES)

- Minimum of five years of writing or copyediting experience in a regulated environment, eg, 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 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.

TECHNICAL/FUNCTIONAL COMPETENCIES

- 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 Excel, MS Outlook, MS Visio, MS PowerPoint, SnagIt and an aptitude for graphic design and clean visual presentation