Kelly Services Technical Writer in Lexington, Massachusetts
Kelly Services is looking for a Technical Writer in Lexington, MA
10 month contract with possible extension
Pay Rate based upon experience
GENERAL POSITION SUMMARY:
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.
GENERAL RESPONSIBILITIES AND REQUIRED SKILL:
• 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
PREFERRED EDUCATION AND EXPERIENCE:
• 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
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.