Medical Promotional Review Consultant (Brazilian Portuguese/English)

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. As the world’s largest RCO (Research Consulting Organization), 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 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 and established brand and derivative materials for assigned projects.
• Acting as lead for medical role during promotional 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.

Essential Functions

• Provide detailed review of promotional, disease awareness and medical only materials for scientific and medical accuracy.
• Participate in cross functional team meetings and prioritization of discussions for the assigned promotional review team.
• Communicate information provided during promotional 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 guidance's, 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 Divisions (NAD) or other governing bodies.
• As appropriate, attendance at major FDLI, DIA, and other industry/FDA meetings.
• Other duties as assigned.

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 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 MS Office, Adobe Acrobat.
• Proficiency in Veeva 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

• 5+ years of related experience in the pharmaceutical/biotech industry is required. May consider related experience from healthcare advertising agency.
• Functional experience in pharmaceutical industry medical affairs is required.
• Strong project management experience in pharmaceutical industry is preferred.
• Knowledge of ENVISA health authority regulations

Language Requirements

• Mother tongue fluency in Brazilian Portuguese
• Fluent in English