Job Description

HCLTech is looking for a highly talented and self- motivated Promo / Ad Specialist ( Regulatory Affairs ) to join it in advancing the technological world through innovation and creativity.

Job Title: Promo / Ad Specialist ( Regulatory Affairs )

Job ID: 1624509BR

Position Type: Full Time with HCLTech

Location: Irvine, CA ( Onsite )

Role/Responsibilities

• Support review of advertising and promotional material to ensures that it meet all medical, legal, and regulatory (MLR) process requirements.
• Facilitate review meetings online and offline coordination with authors, reviewers/approvers to get content approved to support business needs.
• Act as SME for Neurovascular Ad Promo process, providing guidance to authors and reviewers on regulatory and internal policy requirements.
• Support preparation of US and International promotional labeling material including creation of claims matrix database and claims objects.
• Lead AI/ML adoption in content and claims management to support automation and enhance process efficiency.
• Drive the pending review/approval requests for Ad Promo, work with reviewers to push the approvals in a timely fashion.
• Create reports & metrics to provide visibility to management on cycle times of review/approval
• Process improvement: work with cross-functional team to map the process, identify bottlenecks, provide solutions, and author new process documents
• Monitor changes and compliance with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct
• Provide training support for new authors, asset owners, and reviewers/approvers
• Facilitate review/approval system changes and user support
• Excellent communication & organizing skills
• US and International medical device industry experience in Advertising & Promotional labeling
• Knowledge of FDA, EU, and TGA requirements
• Knowledge of Neurovascular brain therapies
• Experience of working with 510(k) and/or IDE and/or PMA devices
• Product Labeling requirements and standards
• Technical Writing experience
• Systems Knowledge such as content management systems, document management, workflow design
• Business system analysis

Qualifications & Experience

Minimum Requirements

• Bachelor’s degree in science, communication, or healthcare related field
• 5+ years of medical device experience including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling
• Or advanced degree with 3 years’ experience
• Proficiency with Veeva PromoMats, Ad Promo/MLR claims and material review and approval systems

Pay and Benefits

Pay Range Minimum: $34.61 per hour

Pay Range Maximum: $51.53 per hour

HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to [email protected] for investigation.

Compensation and Benefits

A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.

How You’ll Grow

At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

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