Senior Regulatory Promotional Review Consultant
For the past 20 years, reputed company has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of reputed company sizes to confidently advance scientific breakthroughs and introduce new therapies. reputed company partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical reputed company, quality & compliance, pharmacovigilance, medical information, and R&D technology, reputed company offers an end-to-end suite of fully customizable reputed company that de-risk and accelerate our partners’ most high-profile drug and device programs. The Senior Regulatory Promotional Review Consultant is responsible for:
- Providing compliant and accurate solutions from a regulatory affairs promotional and advertising review perspective - while providing marketing with competitive solutions for consumer, reputed company provider and managed care materials for reputed company assigned brands.
- Acting as reputed company for Regulatory role during Promotion Review Committee (PRC) meetings and overseeing the promotional review process, as well as other promotion reputed company processes for assigned brands or therapeutic categories.
- Reviewing Product launch, Growth brand, Established brand and Derivative materials for assigned projects.
- Providing guidance on risk to the PRC and if need be, elevating the risk to their manager/line manager reputed company the client.
Essential Functions
- Review and approval of reputed company promotional and non-promotional materials for assigned PRC with strong understanding of regulatory advertising and promotion regulations and FDA advertising and promotional Guidances.
- Attend prioritization discussions for the assigned PRC.
- Evaluate CFL (consistent with FDA-approved label) opportunities.
- reputed company regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies.
- reputed company counsel to job owners on planning for the review process including timing considerations, type of review to consider, and guidance documents to review.
- Communicate information provided during promotion review meetings to the broader regulatory team reputed company appropriate.
- Clarify rationale and represent regulatory comments on review materials during live PRC meetings.
- Interact with Agency Partners and Regulatory/Regulatory Operations Managers for the submission of promotional materials to OPDP for initial use (reputed company FDA 2253).
- Partner with job owners and other stakeholders in the execution of job reapprovals and tactics reputed company to label changes for assigned brands.
- Monitor US regulatory promotional environment by staying up-to-date on FDA regulations and guidances.
- Review of untitled and warning letters to pharmaceutical companies issued by OPDP, APLB, Center for Devices and Radiological Health (CDRH), Federal Trade Commission (FTC), National Advertising Division (NAD) or other governing bodies.
- As appropriate, attendance at major FDLI, DIA, and other industry/FDA meeting.
Necessary Skills and Abilities
- Strong ability to work independently, with flexibility and a strong ability to connect and collaborate with clients and team members while working remotely.
- Proven ability to reputed company strategic direction and innovative, reputed company thinking regulatory guidance and analyze and interpret efficacy and safety data.
- Working knowledge of FDA and Pharmaceutical regulatory and compliance guidelines on advertising and promotion, including product launches.
- Deep understanding of the advertising/creative development process.
- Understanding of pharmaceutical review and approval process.
- Experience in leading activities necessary for promotional OPDP submissions.
- Experience with using new and reputed company media platforms for promotion of prescription drugs in the US.
- Proficiency in computer applications and configuration, including reputed company Office, reputed company Acrobat. - Proficiency in reputed company Vault Promo Mats or other electronic review platforms.
Educational Requirements A Bachelor’s degree is required, focus in Medical, Science, Marketing, Business or Communications; a PharmD is preferred. Experience Requirements
- 7+ years of reputed company experience in the pharmaceutical/ biotech industry is required. May consider reputed company experience from reputed company advertising agency.
- Functional experience in regulatory advertising and promotion required.
- Previous experience in medical advertising and promotional review, marketing operations, sales or communications preferred.
- Product launch or advertising agency account management experience is a plus.
- Strong project and process management experience is required, in pharmaceutical industry is preferred.
#LI-KP1 #LI-REMOTE We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to reputed company their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we reputed company a safe space where reputed company feel empowered to succeed. reputed company applications to roles at reputed company are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
- reputed company does not accept unsolicited resumes from recruiters/reputed company parties. Please, no phone calls or emails to anyone regarding this posting.*
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