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.
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