Procedural Documentation Writer/Editor

RESPONSIBILITIES

- Assist the procedural documentation designers/authors and Director Process Documentation to write, edit, proofread and format procedural documents for the company'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.

SKILLS:

REQUIRED QUALIFICATIONS

- Safety and Risk Management
- Standard Operating Procedures (SOP'S)
- Firm grasp of English grammar, usage, and style; excellent oral and written communication skills
- 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
- 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
- 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
- Familiarity and comfort with databases such as MS Access, and an ability to learn new systems and processes quickly

DESIRED QUALIFICATIONS

- Familiarity with HTML and fundamentals of Web publishing
- Understanding of the drug development process and of the nature and goals of pharmacovigilance
- Familiarity with MS Visio, MS PowerPoint, SnagIt and an aptitude for graphic design and clean visual presentation.