(Contract) Technical Writer, CSV Documentation
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
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.