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Technical Writer II in Lexington, MA at Integrated Resources, Inc

Date Posted: 3/2/2019

Job Snapshot

Job Description

The Standard Operating Procedures (SOP) Technical Writer is responsible for working with Subject Matter Experts (SMEs) to prepare new or changes to existing Policies, SOPs, and Work Instructions as part of an overall document harmonization and integration project. The SOP Writer is responsible for implementing the document workflow
process as a formal written procedure as well as being responsible for supporting the development and revision of procedures by applying document standards, criteria and adhering to timelines. Emphasis will be to address procedures from Global Medical Affairs, Global Drug Safety, Global Regulatory Affairs, Research, Non-Clinical Development, Quality Assurance and Compliance and Global Clinical Development Operations.

Supports the full procedural document lifecycle for Policies, SOPs, Work Instructions (WIs) and Forms by serving as a SOP Writer
Works with document owner, global process owner and SMEs to implement agreed upon procedural development applying appropriate document standards and criteria, ensuring terminology consistency across
Collects input from stakeholders and consolidates comments, resolving conflicts collaboratively
Translates process maps or other process representations and applies them to SOP procedures wording
Contributes to the development and maintenance of up-to- date SOP Writer procedures so that the process is used and consistently applied by all SOP Writers
Works with functional area SMEs to develop cross-functional process models
Contributes to the maintenance and updates to the SOP harmonization tracking spreadsheets and timelines, as assigned
Performs other duties, as assigned
Displays the ability to manage customer expectations
Demonstrates proactive thinking and actions
Familiar with cross-functional customer service techniques
Ability to multi-task in a fast-moving environment
Maintains tracking spreadsheets and timelines as assigned

B.S in a scientific or allied health field (or equivalent degree)
5 years of Research and Development medical writing or Research and Development SOP writing experience in the Biotech, Pharmaceutical, or Medical Device Industry, or relevant comparable background preferred
5 years of Research and Development experience required
Experience in working in a GXP environment with emphasis on GCP, GLP, GPV, and GMP
Possesses a solid understanding of document standards, criteria and conventions
Experience working in a system for collaborative document development
R&D Process Modeling/Process Mapping understanding and experience, a plus
Technical writing certification a plus