Regulatory Affairs Specialist-Ad Promo Job Listing at Kelly Services in Bridgewater, NJ (Job ID US3591318_BH9925506)

Description

Regulatory Specialist – Ad Promo (medical device)
Kelly® Science & Clinical is seeking a Regulaotry Specialist for our client, a leading medical device company based in Bridgewater, NJ. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

REMOTE role
Schedule: Monday through Friday 8am to 5pm (eastern time zone- highly preferred)
Length of assignment: 6 months
Pay: $80-100 an hour
Responsibilities

• Responsible for ensuring all promotional, educational, and training materials used in conjunction with the promotion of products conform to all applicable laws and regulations for US and Canada.
• Provides regulatory review and approval of advertising and promotional materials, new campaigns and launch strategies.
• Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies.
• Monitors FDA and FTC activity (as appropriate) including enforcement actions, guidance documents, etc. to analyze impact on Company products and communicates risk to Promotional Review Committee (PRC).
• Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.
• Monitors competitor advertising to keep abreast of market promotional and advertising strategies.
• Provide regulatory support as needed for FDA warning and untitled letters, FTC letters, and direct competitor-to-competitor challenges
• Continually assesses the advertising and promotion related process to enhance efficiencies, compliance and assist with ongoing regulatory training related to products.
• Works closely with the Regulatory Affairs labeling group in order to assess and determine the impact of proposed labeling changes on product promotion.

QUALIFICATIONS/ TRAINING

• Bachelor's degree preferred or equivalent Minimum of 5 years in Regulatory Affairs or relevant experience in a regulated environment. 5+ years of ad/promo experience relevant to medical devices.
• Strong organizational skills and excellent in managing multiple priorities
• Excellent communication skills (oral and written)
• Computer Literacy – Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat and Veeva • Entrepreneurship and focus on customer needs; Good business acumen and sense of urgency
• Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy & increase probability of regulatory success
• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data
• Knowledge of current and emerging issues and trends
• Strong interpersonal skills with the ability to influence others in a positive and effective manner, without authority
•  Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines

 

• What happens next
  Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry—even if this position doesn't work out, you're still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
  Helping you discover what's next in your career is what we're all about,
  #P1

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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