Consultant II

🕒 Agosto 5

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

💼 Consultor

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 39%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Syner-G BioPharma Group

SiteLinkedInTodas as Vagas

201 - 500 funcionários

🏥 Saúde

💼 Consultoria

🏭 Manufatura

Healthcare • Consulting • Manufacturing

A Syner-G BioPharma Group é a principal fornecedora mundial de soluções em química, manufatura e controle (CMC), relações regulatórias e redação médica para o setor biofarmacêutico. Oferecem serviços abrangentes que guiam os clientes através das complexidades do desenvolvimento farmacêutico, submissões regulatórias e conformidade de qualidade, garantindo resultados de alta qualidade. Com uma equipe multidisciplinar, a Syner-G integra ciência, engenharia e expertise regulatória para apoiar o desenvolvimento de medicamentos desde a fase pré-IND até as fases pós-aprovação, permitindo submissões tempestivas e aderência à segurança do paciente.

Descrição

• Lead regulatory review and approval of US and Canadian promotional, advertising, disease awareness, training, congress, payer, market access, patient support, corporate communication, and digital materials. • Evaluate materials for approved-label consistency, scientific evidence, fair balance, risk communication, comparative claims, audience targeting, and regulatory compliance. • Conduct risk assessments and provide recommendations for compliant stakeholder communications. • Serve as the Regulatory Affairs representative on promotional review committees. • Collaborate with Medical Affairs, Legal, Commercial, Market Access, Corporate Affairs, Pharmacovigilance, and Compliance partners. • Resolve regulatory comments with internal stakeholders and external agencies. • Represent Regulatory Affairs in interactions with alliance partners and global teams. • Provide strategic guidance on FDA and OPDP requirements, prescription drug advertising, promotional labeling, product claims, risk communication, and submission readiness. • Advise on Health Canada advertising requirements, PAAB standards, and Canadian promotional review expectations. • Support promotional strategy for product launches, lifecycle management, label changes, and new indications. • Guide claim development, evidence-generation strategies, competitive positioning, and use of clinical, real-world, and health-economic evidence. • Support PAAB submissions, responses, and approval strategies. • Monitor FDA, OPDP, Health Canada, PAAB, and industry developments. • Communicate regulatory changes and business implications to stakeholders. • Develop and deliver training programs, job aids, and best practices. • Support continuous improvement in review workflows, documentation, governance, escalation pathways, and inspection/audit readiness.

🎯 Requisitos

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline required. • Minimum 3–5 years of experience within the pharmaceutical, biotechnology, biologics, biosimilars, regulatory, or health authority environment. • Significant experience in advertising and promotional regulatory review. • Experience participating in multidisciplinary Medical/Legal/Regulatory review processes. • Demonstrated ability to influence cross-functional teams while maintaining regulatory integrity. • Strong knowledge of FDA promotional requirements and OPDP expectations. • Strong understanding of Health Canada advertising requirements, PAAB Code standards, and the Canadian preclearance process. • Ability to evaluate clinical evidence, product labeling, safety information, comparative claims, real-world evidence, and market access messaging. • Knowledge of fair balance principles, risk communication, claim substantiation, and evidence-based promotional practices. • Strong project management, prioritization, and decision-making capabilities. • Excellent written and verbal communication skills. • Advanced degree preferred. • Preferred: experience with US and Canadian promotional reviews, OPDP advisory submissions, FDA promotional correspondence, PAAB submissions, product launches, label updates, digital campaigns, omnichannel initiatives, electronic promotional review systems, document management platforms, reference management tools, audit-ready documentation, and mentoring junior professionals. • Ability to travel to client sites up to 100% based on project demands and client expectations. • Syner-G is unable to sponsor or take over sponsorship of an employment visa.

🏖️ Benefícios

• Market competitive base salary • Annual incentive plan • Robust benefit offerings • Remote work/flexibility • Ongoing recognition and career development opportunities • Generous flexible paid time off program • Company-paid holidays • Flexible working hours • Fully remote work options for most positions • Ability to work “almost anywhere”

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