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Technical Writer III

Company:
Artech Information Systems
Location:
Cambridge, Massachusetts, United States
Posted:
November 12, 2018

Description:

Job Description:

Job Title: Technical Writer III

Job ID: BIOBJP00000540

Location: Cambridge, MA

Duration: 12 Months

Position Summary:

• Create and update policies, standard operating procedures (SOPs), job aids and other types of controlled documents for all functions within R&D.

Essential Job Functions:

• Prepare and review controlled process documents to ensure submitted procedures are compliant and meet the requirements of R&D document control procedures.

• Support Process Owners in the development and streamlining of content, including processing mapping and RACI tables.

• Work with subject matter experts and key functional department personnel to ensure timely development and accurate content of required documentation.

• Recommend revisions or changes in scope, formatting, and content as identified.

• Perform Quality Control reviews on process document content and formatting.

• Maintain and coordinate activities related to the document creation using the EDMS including document initiation, workflow support, revision, and retirement.

• Monitor shared mailboxes for documentation related requests; engage wider team for support in responding to non-documentation requests, as required.

Education:

• B.A. or B.S. degree or equivalent required

Experience:

• Minimum of five (5) years of experience writing controlled documentation in the biotechnology or pharmaceutical industry

• Direct experience in GXP-compliant quality systems is preferred

• Knowledgeable in FDA regulations

• Experienced in Microsoft office applications specifically Word, Excel and Visio

Skills:

• Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes;

• Excellent communication skills including: technical writing, interpersonal and collaborative skills;

• Excellent organization skills with the ability to stay accountable to deliverables and milestones;

• Ability to thrive and multi-task in a steady-paced environment;

• Must have in-depth knowledge and understanding GXP regulations, and controlled document management principles;

• Must work effectively in a team environment and with individuals at all levels within an organization.