MedFocus Technical Writer I in Massachusetts
Description: A Technical Writer I is needed for a 6-month contract position at major pharma company in New England area.
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.
QUALIFICATIONS Education B.A. or B.S. degree or equivalent required
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
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.
Please send resume to email@example.com
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