(Contract) Technical Writer, CSV Documentation

Norwood, MA
March 07 2019
Life Sciences, Biology
Organization Type
(Contract) Technical Writer, CSV Documentation

The Role:

Reporting to the Senior Manager of GxP Quality Computer Systems. The Technical Writer/Analyst Role will support the content development and revisions of various procedural and validation documentation for GxP Digital System Lifecycle activities. The anticipated time frame for this role will be 6 months.

Here's What You'll Do:
  • Author, design and manage computerized system validation (CSV) documentation (Plans and Summary Reports, Risk Assessments, Design Configuration/Specification, User and Functional Requirements, IQ/OQ, PQ, Trace Matrix, etc.).
  • Transforms business and functional requirements and technical information into effective and traceable testing.
  • Supports the implementation of processes and/or tools to maintain compliance.
  • Evaluates, develops and revises Digital Process and Validation SOPs, Forms, and Documentation to meet business and regulatory requirements.
  • Assists in editing documents for accuracy and ensures all comments and recommended revisions are addressed.
  • Manages documentation, tracks dates and versions of documents to ensures that documents are updated according to project and SOP requirements.
  • Verifies all documents for a given project are completed and processed.
  • Ensures current documentation status is maintained/updated within project trackers.
  • Manages or assists SMEs with Change Controls.
  • Provides GxP Digital team with technical writing assistance

Here's What You'll Bring to the Table:
  • Bachelor's Degree in a scientific background or another relevant academic discipline.
  • At least 3-5 years of demonstrated experience designing, implementing, and supporting compliance systems in FDA regulated industry.
  • Knowledge of cGxP, 21 CFR Part 11, Annex 11, GAMP 5 is highly desirable.
  • Experience with SDLC methodologies in a cGxP regulated environment.
  • Excellent documentation and communications skills.
  • Strong interpersonal skills with ability to work collaboratively within a team of stakeholders.
  • Self-directed with effective analytical and problem-solving skills.
  • Capable of operating within a fast-moving business environment.
  • Familiarity and experience with electronic document management systems and automated software testing system a plus

Why join Moderna Therapeutics

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.


Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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