Senior Manager, Regulatory Promotional Operations

Job Description

The Senior Manager, Regulatory Promotional Operations, is a subject matter expert specializing in the preparation and delivery of submission packages for promotional materials to be reviewed through the client Medical, Legal, Regulatory (MLR) process.

Acting as a lead for a brand or portfolio of brands, the Senior Manager oversees a team of Associates, Senior Associates, and Managers to ensure a seamless MLR review process from start to finish.

The Senior Manager provides expert guidance on submission timelines and resource requirements, ensuring that all deadlines are met.

They are also responsible for delegating projects effectively across a team of direct and indirect reports.

In this role, the Senior Manager plays a crucial part in establishing and refining procedures for internal teams and advising on specific projects to facilitate a smooth and efficient review process.

Their expertise and leadership are vital for driving the success of the submission process and ensuring compliance with client-specific and regulatory requirements.

DUTIES & RESPONSIBILITIES :

• Act as a brand lead or oversee a portfolio of brands, managing the submission process and ensuring alignment with client expectations and regulatory requirements.
• Independently prepare and / or oversee the creation of high-quality submission packages through taking screenshots, organizing materials to output a compliant submission PDF, and annotating pertinent information.
• Manage multiple direct reports at the Associate, Senior Associate, and Manager levels, including responsibilities for interviewing, hiring, onboarding, training, and career development.
• Coordinate the delegation of work among reporting staff to manage workflow across accounts, ensuring appropriate resources are available to meet client demands.
• Provide oversight of reporting employees' daily work, offering advice on projects, assisting with problem-solving, and managing projects directly as needed.
• Provide estimates for Statement of Work (SOW) development and partner with the Project Management team on submission timelines and resource requirements.
• Maintain a comprehensive and accurate dashboard of all current and upcoming submissions, including the stage of review and submission deadline.
• Follow up directly with client liaisons to ensure submissions are received on time and meet all client expectations and specifications.
• Partner with cross-functional leads and client teams to continuously improve and refine processes and deliver high-quality work.
• Create, update, and disseminate to department / team documentation on client specific guidelines.
• Actively manage team expectations; directly interface with clients as required.

Qualifications

Required

• Bachelor’s degree in a relevant field and 4-6 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.

Preferred

• Agency and / or project management experience.
• Proven experience working within cross-functional teams.
• Clear, concise technical writing ability.
• Working knowledge of Adobe InDesign and Photoshop.

Desirable

Demonstrated knowledge of FDA regulations for promotional materials, gained through appropriate training or previous experience.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Compensation Range : $35.34- $59.38 / hr. 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.

This role may be eligible to participate in our freelancer / temporary employee medical plan through a third-party benefits administration system once certain criteria have been met.

This role may also qualify for participation in our 401(k) plan after eligibility criteria have been met .The Company anticipates the application deadline for this job posting will be 10 / 22 / 2024.