Regulatory Affairs/Medical Writing Specialist

Somerville, NJ

Job ID: 127856 Industry: CLINICAL


Regulatory Affairs/Medical Writing specialist  


Project Description:


Responsibilities include, supporting advertising and promotion to meet company needs for claims lists and supporting documentation of claims as part of the CER reports and audit readiness per new EU MDR guidelines. The Ad Promo staff is a member of the Global Strategy and Ad Promo Regulatory Affairs team.   S/he is responsible for harmonizing the advertising and promotion regulatory compliance activities, as well as defining and implementing process improvements to support advertising and promotional plans and ensure adherence to compliance requirements.  
  • Conduct regulatory promotional labeling and marketing compliance reviews to ensure that materials and communications are consistent with product labeling, are adequately supported and comply with applicable laws, regulations and policies for all types of products, as appropriate.
  • Partner with Marketing cross-functional reviewers (e.g. Quality, Regulatory, Medical Affairs, Marketing, Healthcare Compliance, Legal, HE&R, Data Privacy, Communications, etc.) to identify claims and supporting documents. 
  • Actively participate in internal & external audits.

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