Technical Writer – Drug Safety

Job Description

The Technical Writer will assist with Quality Assurance (QA) documentation related to post-market safety surveillance, investigation decisions, correction action/preventative action (CAPA), root cause investigations (RCI), and QA procedures. The documentation will consist of technical reports, meeting minutes, monthly/quarterly/annual surveillance reports, and creation/updating of procedures. 

• The Technical Writer will work with Quality Assurance, Medical Affairs, Engineering and other departments as necessary to complete documentation requirements. 

Skills Required: 

• Strong knowledge of Microsoft Office products. Good communication skills. Ability to write clearly and succinctly regarding scientific topics. Ability to manage multiple reports while working with multi-function teams. Ability to understand, compile and describe technical data. 

• Adheres to environmental policy, procedures, and supports department environmental objectives. 

ESSENTIAL FUNCTIONS / RESPONSIBILITIES 

II. List 4-10 of the major end results the position is to accomplish and show approximate percentage of time devoted to each. Describe in terms of broad responsibilities rather than specific tasks. 

• Documents monthly, quarterly, and annual reports for post-market safety surveillance activities (30%) 

• Proactively manages the completion of multiple investigation decision reports with risk management team, safety management team and product quality managers (60%) 

• 3Perform other related duties assigned by management for Quality Assurance activities (10%) 

Qualifications

QUALIFICATIONS 

III. Minimum education required for competent performance: 

• Bachelor’s degree 

• Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance: 

• 2 years performing technical writing as part of prior job duties (i.e. published papers, reports, etc.). 

• Excellent understanding and application of principles, concepts and practices of Risk Management, Statistical Methods, Root Cause Analysis/Failure investigation. 

IV. Volume or unit measure of job duties: (List the volume of those duties which are repetitive in nature. For example, 75 customer phone calls per day, 20 boxes packed per day, etc.) 

NA 

V. Equipment usage and abilities needed: 

• Personal Computer, Printer, Telephone, Facsimile, Copier, Calculator, Microsoft Office Products, Other software as required

Additional Information

For more information, please contact

Best Regards,

Sneha Shrivastava

Technical Recruiter (Clinical/Scientific)

 Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 

Office: 973.967.3348 | Fax: 973.998.2599

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