Consultant II

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🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

💼 Consultant

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Syner-G BioPharma Group

Site WebLinkedInTous les Emplois

201 - 500 employés

🏥 Santé

💼 Conseil

🏭 Fabrication

Healthcare • Consulting • Manufacturing

Syner-G BioPharma Group est le leader mondial dans la fourniture de solutions en chimie, fabrication et contrôles (CMC), affaires réglementaires, et rédaction médicale pour le secteur biopharmaceutique. Ils offrent des services complets qui guident les clients à travers les complexités du développement pharmaceutique, des soumissions réglementaires, et de la conformité qualité, assurant des résultats de haute qualité. Avec une équipe multidisciplinaire, Syner-G intègre la science, l'ingénierie et l'expertise réglementaire pour soutenir le développement de médicaments depuis les phases pré-IND jusqu'à la post-approbation, permettant des soumissions en temps opportun et une adhésion à la sécurité des patients.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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”