HCLTech
Promo / Ad Specialist ( Regulatory Affairs )
HCLTech, Irvine, California, United States, 92713
Promo / Ad Specialist ( Regulatory Affairs )
Job ID:
1624509BR
Position Type:
Full Time with HCLTech
Location:
Irvine, CA (Onsite)
Base Pay Range:
$34.61/hr - $51.53/hr
Responsibilities
Support review of advertising and promotional material to ensure it meets all medical, legal, and regulatory (MLR) process requirements.
Facilitate review meetings online and offline coordination with authors, reviewers/approvers to get content approved for 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 pending review/approval requests for Ad Promo, work with reviewers to push 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 with 510(k), 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
Bachelor’s degree in science, communication, or healthcare related field.
5+ years of medical device experience including knowledge of 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
Benefits include:
medical, dental, vision, pharmacy, life, accidental death & dismemberment, disability insurance; employee assistance program; 401(k) retirement plan; 10 days paid time off per year; 10 paid holidays per year.
Equal Opportunity Employer 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 secure@hcltech.com for investigation.
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1624509BR
Position Type:
Full Time with HCLTech
Location:
Irvine, CA (Onsite)
Base Pay Range:
$34.61/hr - $51.53/hr
Responsibilities
Support review of advertising and promotional material to ensure it meets all medical, legal, and regulatory (MLR) process requirements.
Facilitate review meetings online and offline coordination with authors, reviewers/approvers to get content approved for 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 pending review/approval requests for Ad Promo, work with reviewers to push 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 with 510(k), 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
Bachelor’s degree in science, communication, or healthcare related field.
5+ years of medical device experience including knowledge of 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
Benefits include:
medical, dental, vision, pharmacy, life, accidental death & dismemberment, disability insurance; employee assistance program; 401(k) retirement plan; 10 days paid time off per year; 10 paid holidays per year.
Equal Opportunity Employer 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 secure@hcltech.com for investigation.
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