Senior Medical Promotional Review Consultant - RN, Clinical Experience

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Senior Medical Promotional Review Consultant is responsible for:

• Providing compliant, medically accurate and scientifically sound solutions - while providing marketing with competitive solutions for consumer, healthcare provider and managed care promotional and non-promotional materials.
• Review of independent scientific/ medical/clinical materials for Product launch, Growth brand, Established brand and Derivative materials for assigned projects.
• Acting as lead for Medical role during Promotion Review Committee (PRC) meetings and overseeing the medical advertising promotional review process.
• Providing guidance on the Medical /scientific support for PRC and if need be, elevating the risk to their manager/line manager within the client.
• Provide detailed review of promotional, disease awareness and medical only materials for scientific and medical accuracy.
• Participate in cross functional team meetings and prioritization discussions for the assigned promotion review team.
• Communicate information provided during promotion review meetings to the broader Medical team when appropriate and elevating risk items to management.
• Partner with job owners and other stakeholders in the execution and creation of tactics related to label changes for assigned brands.
• Stay up to date with relevant clinical data, publications, and treatment guidelines published by medical associations.
• Monitor US regulatory promotional environment by staying up to date on FDA regulations and guidances, reviewing untitled and warning letters issued to pharmaceutical companies published 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 meetings.

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 provide strategic direction and innovative, forward thinking medical guidance and analyze and interpret efficacy and safety data.
• Working knowledge of FDA and Pharmaceutical regulatory and compliance guidelines on advertising and promotion.
• Deep understanding of scientific data from clinical trials, review articles, medical textbooks, etc. and how this data supports claims made consistent with the FDA approved label. Understanding of pharmaceutical advertising/creative review and approval process. Proficiency in computer applications and configuration, including Microsoft Office, Adobe Acrobat. Proficiency in Veeva Vault PromoMats or other electronic review platforms.

Educational & Experience Requirements:

• RN with Clinical Experience
• 7-10 years of promotional review experience that includes devices.
• Functional experience in pharmaceutical industry medical affairs is required.
• Strong project 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 unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma 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.

• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*

Apply tot his job Apply To this Job