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Technical Writer

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Position Summary: Responsible for creating and writing technical and controlled documents including standard work instructions, standard operating procedures, forms, how-to guides, work aids, references, manuals, or other forms of instruction. Prepare and review of batch records, validation protocols, validation studies, process flows, deviations and CAPAs documentation according to defined standards. Key Responsibilities: • Explain scientific and technical ideas in clear and concise language.
• Meet with and or interview Operations staff to establish technical specifications for operational activities and tasks.
• Study process flows, specifications, mockups.
• Create user documentation for a variety of material, including Work Instructions, SOPs, flow charts and other work aids.
• Ensure technical verbiage is easy to understand by the lay person.
• Gather information on relevant subjects in libraries and on the web.
• Prepare charts, graphs, or forms to go along with written drafts.
• Ensure fields, processes and work flow in the correct sequence.
• Write clear and concise policies and procedures based on recommendations and standards.
• Create tables of contents and cite sources.
• Submit copies to managers for feedback.
• Adjust documents as necessary and proofread for grammar and spelling.

Minimum Requirements/Qualifications:
• Must be able to work both independently and as part of a team, meet deadlines, and perform and prioritize multiple concurrent tasks.
• Requires use of discretionary initiative and judgment when handling confidential information.
• Candidate must be able to handle fast-paced environment while maintaining close attention to deadlines, detail, and quality of workmanship.
• Highly proficient with MS Office, to include strong competency with Microsoft Word, and Excel. Proficiency with Microsoft Project and/or Visio desirable.
• Familiarity with reporting, collaboration, and content management tools (e.g., SharePoint, Adobe Acrobat, Master Control).
• Proficient in developing and presenting, both verbally and in writing, technical information and presentations to non-technical audiences.
• Ability to interpret technical documentation standards. Working Conditions - Office, laboratory and warehouse. Must be capable of working at a computer for up to eight hours a day. Non-Negotiable Hiring Criteria -
• Minimum of 3 years of scientific writing experience
• Strong oral and written communication skills.
• Requires excellent written and verbal English, excellent organizational and time-management skills, excellent interpersonal skills, and competence with Internet searches.

Education:
Bachelors and three or more years of technical writing experience, preferably in a healthcare, research, or academic environment. Preference will be given to candidates with advanced degrees in the sciences and/or journalism training. Ideally, the candidate will also have experience working with digital media and documents in a cGMP environment.

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