Part time Regulatory Marketing Consultant

job summary: • Our client is seeking a part time Marketing Consultant to work approximately 20 hours per week, preferred Tues-Thurs in line with the NC HQ business hours. • The Advertising and Promotion Regulatory Affairs role will provide strategic regulatory expertise, and guidance to internal and external stakeholders related to the review of scientific information, advertising, promotional and other related materials for assigned products to ensure compliance with applicable regulations and guidance documents. The individual will represent regulatory on the PRC (Promotional Review Committee) team for assigned products and must possess a thorough knowledge of regulations for advisement and promotional compliance, governing drugs, device and combination products. The individual should have experience reviewing promotional materials that are subject to both EU MDR and FDA regulations. location: Raleigh, North Carolina job type: Contract salary: $80 - 83 per hour work hours: 8 to 4 education: Bachelors responsibilities: • Review and approve proposed advertising and promotional materials for multiple product lines. • Maintain current awareness of evolving EU MDR and FDA regulations and interpretations, enforcement letters and policy issues affecting the pharmaceutical and medical device industries. • Ensure adherence and compliance to the review and release process. • Provide guidance and risk assessments on proposed claims for products in development and development of ISI (Important Safety Information) and Brief Summaries. • Work closely with R&D project teams and marketing to advise on labeling and launch materials for new products and indications. • Oversee timely and accurate submissions related to promotional materials as needed. This includes supporting audits that may request samples of approved promotional material and documentation of review processes as well as any required submissions to health authorities related to advertising and promotion. • Regularly monitor the regulatory compliance trends in the aesthetic industry, interpret new regulations, guidance documents and enforcement actions. • Regularly monitor and advise on publicly available competitor materials to provide awareness and advice on current market trends and messaging. qualifications: Required: • Bachelor's Degree - a 4-year undergraduate degree in a scientific background (medicine, pharmaceutical sciences, human biology, or chemistry.) • 5+ years' experience in regulatory drug and medical device promotion review • Strong knowledge of EU MDR and FDA regulations and guidance pertaining to drug and device advertising, promotion, and labeling • Proficiency in Microsoft Outlook, Excel, PowerPoint and Word and comfort with large variety of online meeting tools and AV equipment Preferred: • Master's degree or higher in the above field is highly desirable #LI-MT1 skills: Product Marketing, Regulatory Submission Compliance, FDA Submissions, Medical Device Regulation (MDR) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected]. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply tot his job