Director, Regulatory Promotional Operations Specialist
2 weeks ago
Publicis Health is seeking a highly skilled and experienced Director, Regulatory Promotional Operations to join our team. As a key member of our regulatory team, you will be responsible for overseeing the daily operations within a therapeutic area, managing a large portfolio of multifaceted brands, and ensuring alignment with client expectations and regulatory requirements.
Key Responsibilities- Oversee the submission process for a large portfolio of multifaceted brands, ensuring alignment with client expectations and regulatory requirements.
- Supervise the creation of high-quality MLR submission packages, ensuring they conform to internal standards, client-specific requirements, and FDA guidelines.
- Oversee a team of direct and indirect reports, including Associates, Senior Associates, and Managers. Responsible for hiring decisions, onboarding, training, career development, and providing leadership to support team growth.
- Collaborate with the VP, Regulatory Promotional Operations to create, update, and disseminate departmental Standard Operating Procedures (SOPs) and documentation on client-specific guidelines.
- Provide estimates for Statement of Work (SOW) development and advise the Project Management team on submission timelines and resource requirements.
- Build and maintain strong, direct relationships with client MLR teams, acting as the primary point of contact. Ensure timely receipt of submissions and alignment with client expectations and specifications.
- Work with cross-functional and client teams to optimize and improve the submission process, offering recommendations on best practices and driving process improvements.
- Diagnose and address submission quality concerns in collaboration with other capability leads to ensure the highest standards of work.
- Participate actively in strategic discussions with clients, handling complex or challenging submission issues, and facilitating resolutions. Provide leadership and guidance to drive the success of the submission process.
- Bachelor's degree in a relevant field and 6-8 years relevant experience preparing complex submission deliverables under tight deadlines.
- Technical competency in Adobe Acrobat Pro DC and Microsoft Office Suite.
- Proficiency in Veeva Vault PromoMats.
- Meticulous attention to detail.
- Superior organizational skills and ability to effectively manage multiple tasks efficiently.
- Exceptional communication skills and experience communicating with clients directly.
- Experience managing diverse direct reports and devotion to growing talent.
- Courageous leadership skills and a commitment to leading by example.
- Strong presentation skills.
- Demonstrated knowledge of FDA regulations for promotional materials, gained through appropriate training or previous experience.
- Experience working with launch brands.
- Working knowledge of Adobe InDesign and PhotoShop.
Publicis Health provides robust and inclusive benefit programs and policies to support the evolving and diverse needs of our talent and enable every person to grow and thrive. Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off.
All your information will be kept confidential according to EEO guidelines.
Compensation Range: $98,500- $165,500 annually. This is the pay range the Company believes it will pay for this position at the time of this posting. Consistent with applicable law, compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position, and the Company reserves the right to modify this pay range at any time.
-
New York, New York, United States Publicis Groupe Full timeJob DescriptionAt Publicis Groupe, we are seeking a highly skilled and experienced Director, Regulatory Promotional Operations to join our team. This role is responsible for overseeing the daily operations within a therapeutic area, managing a large portfolio of multifaceted brands.Key Responsibilities:Manage a diverse team of direct and indirect reports,...
-
Senior Manager Regulatory Promotional Operations
3 weeks ago
New York, New York, United States Publicis Health Full timeJob Title: Senior Manager, Regulatory Promotional OperationsAt Publicis Groupe, we're committed to fostering a culture of inclusivity and diversity. As a Senior Manager, Regulatory Promotional Operations, you'll play a critical role in ensuring the success of our clients' promotional materials through the Medical, Legal, and Regulatory (MLR) review...
-
Senior Manager Regulatory Promotional Operations
3 weeks ago
New York, New York, United States Publicis Health Full timeJob Title: Senior Manager, Regulatory Promotional OperationsCoLab is a fully integrated, cross-discipline team that provides best-in-class services in a fluid and modular way. With our clients at the center, we create brand movement at the speed of people's lives by connecting real-time data with world-class creative, content, and media in service of growth...
-
New York, New York, United States Publicis Health Full timeJob SummaryWe are seeking a highly skilled Senior Manager, Regulatory Promotional Operations to join our team at Publicis Health. As a subject matter expert, you will be responsible for preparing and delivering submission packages for promotional materials to be reviewed through the client Medical, Legal, Regulatory (MLR) process.Key ResponsibilitiesAct as a...
-
Regulatory Compliance Director
2 days ago
New York, New York, United States The Goodkind Group Full timeJob Profile SummaryThe primary objective of the Regulatory and Accreditation Program is to promote safe, high-quality, and effective patient care through maintaining accreditation, certification, and licensure compliance.The Regulatory Director is responsible for developing and leading a comprehensive regulatory survey readiness program in support of the...
-
Regulatory Compliance Director
4 weeks ago
New York, New York, United States Brains Workgroup, Inc. Full timeRegulatory & Compliance Integration DirectorBrains Workgroup, Inc. is seeking a seasoned Regulatory & Compliance Integration Director to join our team in New York City.This is a permanent position with a competitive compensation package, including a base salary of K, excellent benefits, and a target bonus.The ideal candidate will have a strong background in...
-
Regulatory Affairs Director
3 weeks ago
New York, New York, United States NYC Health Hospitals Full timeJob Title: Director of Regulatory AffairsNYC Health + Hospitals/Jacobi is a 457-bed teaching hospital affiliated with the Albert Einstein College of Medicine. The facility has earned numerous Center of Excellence designations, accreditation, and recognition for its renowned Level 1 Trauma Center, Burn Center, Surgical Intensive Care Unit, regional Stroke...
-
Director, Regulatory Compliance
2 weeks ago
New York, New York, United States EmblemHealth Full timeJob SummaryWe are seeking a highly skilled and experienced Director, Grievance to join our team at EmblemHealth. The successful candidate will be responsible for overseeing the Regulatory Complaint functions, ensuring compliance with all regulatory, state and federal guidelines for all product lines. This role requires a strong analytical and technical...
-
Director of Regulatory Compliance
1 week ago
New York, New York, United States Oscar Health Full timeJob Title: Director, Regulatory ComplianceOscar Health is seeking a highly skilled Director, Regulatory Compliance to join our Corporate Compliance team. As a key member of our team, you will be responsible for overseeing the regulatory implementation process and compliance strategic operations processes.About the RoleThe Director, Regulatory Compliance will...
-
Regulatory Affairs Director
2 weeks ago
New York, New York, United States Tandym Group Full timeDirector of Regulatory AffairsTandym Group is seeking an experienced healthcare professional to join their leadership team as Director of Regulatory Affairs.Key Responsibilities:Performance Metrics and Outcomes: Identify areas needing improvement and design continuous measurement of performance metrics and outcomes.Compliance and Training: Create and deliver...
-
Regulatory Affairs Director
21 hours ago
New York, New York, United States Fairway Consulting Group Full timeJob Title: Associate Director/Director, Regulatory AffairsFairway Consulting Group is seeking a highly experienced Associate Director/Director, Regulatory Affairs to join our team. This is a unique opportunity to work with a leading biopharmaceutical company and contribute to the development of innovative global regulatory strategies.Key...
-
Regulatory Compliance Director
3 weeks ago
New York, New York, United States Brains Workgroup, Inc. Full timeRegulatory & Compliance Integration Director OpportunityBrains Workgroup, Inc. is seeking a talented Regulatory & Compliance Integration Director to join our team in New York City.This is a permanent position with a competitive compensation package, including a base salary of K, excellent benefits, and a target bonus.The ideal candidate will have experience...
-
Director of Regulatory Compliance
3 weeks ago
New York, New York, United States UGI Corporation Full timeJob Title: Director of Regulatory ComplianceJoin AmeriGas, the nation's premiere propane company, as we seek a highly skilled Director of Regulatory Compliance to lead our cross-functional team in ensuring compliance with critical regulatory programs.Key Responsibilities:Develop and maintain a regulatory management program to ensure consistent implementation...
-
Senior Director of Regulatory Affairs
3 weeks ago
New York, New York, United States MetroPlusHealth Full timeJob Title: Senior Director of Regulatory AffairsAt MetroPlusHealth, we are committed to empowering New Yorkers by uniting communities through care. We believe that healthcare is a right, not a privilege. If you have compassion and a collaborative spirit, we invite you to join our team.About MetroPlusHealthMetroPlusHealth provides the highest quality...
-
New York, New York, United States Groupe Crédit Agricole Full timeJob Title: Global Markets Regulatory Compliance Advisory DirectorJoin Groupe Crédit Agricole as a Global Markets Regulatory Compliance Advisory Director and take on a challenging role that requires expertise in regulatory compliance and risk management. As a key member of our team, you will be responsible for providing advice on Swap Dealer and Broker...
-
Medicaid Regulatory Compliance Specialist
4 weeks ago
New York, New York, United States MetroPlusHealth Full timeEmpowering New Yorkers through Quality HealthcareMetroPlusHealth is dedicated to delivering exceptional healthcare services to the residents of New York City. As a leading provider of Medicaid managed care, we are committed to empowering New Yorkers by uniting communities through care. Our mission is to provide the highest quality healthcare services,...
-
Regulatory Remediation Specialist
2 weeks ago
New York, New York, United States Sia Partners Full timeJob Title: Regulatory Remediation SpecialistSia Partners is a next-generation management consulting firm that offers a unique blend of AI and design capabilities. We are seeking a talented Regulatory Remediation Specialist to support our Financial Services practice in serving our clients with regulatory remediation initiatives.Responsibilities:Support...
-
Regulatory Promotional Operations Manager
3 weeks ago
New York, New York, United States Publicis Health Full timeJob DescriptionCoLab is a fully integrated, cross-discipline team that provides best-in-class services in a fluid and modular way. With our clients at the center, we create brand movement at the speed of people's lives by connecting real-time data with world-class creative, content, and media in service of growth and Return on investment.We pride ourselves...
-
Regulatory Affairs Director
3 weeks ago
New York, New York, United States Sun Pharmaceutical Industries, Inc. Full timeSenior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs.Key Responsibilities:Develop and execute novel drug regulatory strategyEnsure development programs are compliant with ICH regulatory requirements and all local country...
-
Regulatory Compliance Director
3 weeks ago
New York, New York, United States Optima Partners Holdings LLC Full timeJob Title: Associate Director of ComplianceOptima Partners Holdings LLC is seeking a highly skilled Associate Director of Compliance to join our team. As a key member of our compliance department, you will be responsible for providing senior oversight of client regulatory compliance matters.Key Responsibilities:Lead or support an entire sales cycle,...