Technical Writer (Entry level drug Safety position)

Technical Writer (Entry level drug Safety position)

Contract

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting / financial flexibility by offering contingent labor as a variable cost.

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

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%)

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

QUALIFICATIONS

Minimum 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.

V. Equipment usage and abilities needed :

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

#J-18808-Ljbffr