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Artech Information System LLC
Seattle, WA

Artech Information System LLC

Senior Manager for Regulatory Affairs

Weston, MA, United States

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Job details

Posting language: English
Posted: May 25, 2017

Original job description

Company Description Artech Information Systems is the #1 Largest Women-Owned IT Staffing Company in the U.S. and an employer of choice for over 7,500 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US. At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources.

Job Description

US Regulatory Advertising and Promotion (US Reg AD/Promo) is responsible for actively contributing to the implementation of regulatory strategy for promotional messaging. The contractor will serve as the regulatory representative on assigned review teams for promotional and non-promotional materials and contribute, as appropriate, to other assigned projects.

Essential functions:

Responsible for accuracy and content of communications with FDA
Extensive knowledge of advertising and promotion regulations and ability to interpret regulations to promotional materials and non-promotional materials
Ability to influence teams
Actively contribute to the development and implementation of regulatory strategy for promotional materials as well as any other assigned projects and programs.
Decision maker in review meetings
Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects and programs. This includes promotional materials, including pre-use submissions for subpart E & H products.
Provide regulatory guidance to cross-functional teams that establish strategy and vision for promotional materials, sales training materials, and other external communications.
Work is performed under general direction. Capable of strategic thinking and risk assessment for area of responsibility. Demonstrate good communication skills (oral/written/listening).

Qualifications

Requires a minimum of 5+ yrs of direct regulatory promotional and non-promotional material review experience.

Additional Information All your information will be kept confidential according to EEO guidelines.

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More about this job

Skills

Regulatory affairs
Interpret law
Sales
Hazard assessment
Communication skills

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