Job Summary: The ideal candidate should have a background writing documents for the pharmaceutical industry and should be an excellent communicator. The writer will work with the quality consultants and subject matter experts to ensure documents are correct and complete and will have experience managing documents through a regulated document repository system. The writer will perform quality checks and edits as requested, meeting company-defined deadlines. The ideal candidate should be flexible and able to adapt to support other documentation tasks from time to time as the need arises.
Desired Skills/Experience Writing and Grammar Skills

• Possesses excellent grammar skills and is comfortable editing documents for grammar. Is familiar with the American Medical Association Manual of Style.
• Comfortably and clearly communicates by writing, speaking, and listening in American English
• Interprets and writes technical documents to communicate complex information
• Performs quality checks to ensure documents are compliant with document conventions and templates
• Collaborates with other coworkers and clients to produce satisfactory material
• Creates documents using business process maps
• Writes "how-to" instructions to create aids to help coworkers perform job functions
• Creates checklists, templates and document conventions or other guidance documents
• Manages time well, keeping with strict deadlines. Capable of editing multiple documents concurrently and being flexible to drop in work and timelines on time.

Technical and Software Skills

• Possesses expert Microsoft Word skills to aid in solving difficult troubleshooting with issues such as section breaks, tables, styles, table of contents, hyperlinks, compare function, tracked changes
• Is highly proficient at generating spreadsheets in Excel; can use, write, and/or edit complex Excel formulas
• Uses and occasionally edits macros in Word, Excel, and PowerPoint
• Creates complicated flow charts and other diagrams in Visio
• Creates presentations in PowerPoint
• Uses Outlook or another email system to communicate, schedule meetings, populate calendars, and organize information
• Troubleshoots and solves computer-related problems.

Interpersonal and Communications Skills

• Schedules and runs meetings as needed with the client or teammates
• Informs supervisor and team members of project status. Supports other team members. Participates in team/client meetings.
• Works with tight deadlines, working within the budgeted hours, communicating any changes to the manager, and escalating important issues
• Nurtures and grows a positive relationship with the client. Is receptive to feedback.

Industry Knowledge

• Has general knowledge of working in a regulated environment
• Familiar with the regulators and regulations that govern the pharmaceutical industry such as good manufacturing practices (GMP), good clinical practice (GCP), World Health Organization (WHO), chemistry, manufacturing, and controls (CMC), European Medicines Agency (EMA), Food and Drug Administration (FDA) and other common technical documents (CTD).

• Minimum 3-5 years of experience in Technical Writer role
• Should have working experience in SOP writings
• Strong Knowledge on English Grammar and content writing
• Working experience on MS VISIO or any related tools
• Strong Writing, editing and organizational skills