MLR Submissions Manager

Work From Anywhere in the U.S. - Remote Friendly Role - Chicago/Midwest Preferred #LinkedInRemote

Level Ex® (a Brainlab company) uses state-of-the-art video game technology and cognitive neuroscience to accelerate the adoption curve of new techniques and products in medicine. Using the psychology of entertainment - our games drive an order of magnitude more engagement than other digital HCP marketing and training approaches… and we are just scratching the surface of what is possible.

Our games revolutionize how medical professionals advance their clinical skills, earn CME, and keep up-to-speed on challenging cases, new drug therapies, medical devices, and clinical best practices. The company's medical video games run on phones, tablets, and web browsers, and are played by over 1 Million healthcare professionals. Our latest cloud-gaming platform allows multiple users to diagnose or treat a virtual patient collaboratively over video-conferencing platforms like Zoom. Top 20 pharmaceutical and medical device companies (including J&J, Amgen, Philips, Baxter, and many others), national medical societies, and government organizations such as NASA leverage Level Ex's acclaimed HCP education and training platform.

We're currently seeking an experienced MLR Submissions Manager, who will report to our Medical Team Manager, to manage and drive MLR submissions for our award-winning pharmaceutical client projects, ensuring their success and compliance.

Responsibilities

• Collaboratively review and approve advertising and promotional materials before submission, working across departments to ensure accuracy and compliance.
• Directly manage and execute the preparation and submission of video games, marketing assets, and supportive documentation for MLR/FDA approval, owning the process from start to finish.
• Cultivate and maintain outstanding client relations, demonstrating exceptional communication skills and a commitment to client satisfaction.
• Coordinate with our life sciences clients and vendors to continue to streamline the submission process, ensuring that all external contributions meet our high standards for quality and compliance.
• Communicate proactively with all stakeholders, providing both technical and strategic input to facilitate successful MLR/FDA approvals.
• Serve as an integral team member, actively contributing to meetings, highlighting priorities, and driving toward deadlines with a focus on ownership and accountability in all MLR submissions.
• Ensure adherence to industry standards for all MLR submissions in alignment with FDA/OPDP regulations, pharmaceutical client specifications, and internal policies.
• Establish and maintain a comprehensive archiving system for all submission documentation and AFD materials, ensuring easy access and compliance.
• Actively contribute to process improvement initiatives by identifying and implementing optimization strategies for the MLR submission workflow.

Qualifications

• Minimum of 2 years of direct experience in MLR submissions, showcasing a deep foundation in proofing and technical documentation within the life science sectors.
• Demonstrated proficiency in Veeva Vault is essential, Veeva Certification is highly desirable and a future requirement if you don't currently have it.
• Experience coordinating with life sciences clients and vendors to ensure timely and compliant contributions to MLR submissions, emphasizing a collaborative and results-oriented approach.
• Track record of fostering excellent client relationships, with the ability to communicate effectively and maintain high satisfaction levels.
• Experience in navigating ambiguity and engaging cross-functional teams to create and implement efficient processes, enhancing teamwork and productivity.
• Exceptional verbal and written communication skills, necessary for clear and effective interactions with clients, team members, and regulatory bodies.
• Proficiency in Adobe Acrobat, G-Suite, and Microsoft Office is required; familiarity with project planning software is preferred.
• Openness to leading and coaching as the role/team grows, coupled with a proactive approach to refining processes, enhancing efficiency, and driving innovation within our MLR submission framework.
• Outstanding attention to detail combined with superior planning and organizational skills, ensuring meticulous management of all aspects of MLR submissions.
• Additional experience with online proofing platforms such as Ziflow or another is preferred.
• Ability to multitask and prioritize work effectively, even under deadlines or when faced with competing timelines, to maintain project momentum.

Salary Range

• The salary range for this position is $80,000 to $100,000 annually, based on experience and qualifications.

Benefits & Perks

• Multiple health insurance plans with 100% company-paid premiums.
• 401(k) with a generous company-paid match.
• 100% remote for all U.S. employees.
• Family-friendly benefits; 4 weeks of PTO, 2 weeks of company holidays, dental, vision, optional pet insurance, and more!
• Remote-friendly events (i.e. board games tabletop simulator, Jackbox Games, DEI events, game jams, virtual happy hours).

Interested?

For the fastest consideration please send us your resume along with an optional cover letter. Meet some of our incredible team here, and learn why you'll enjoy our company and culture – video: Why Join Level Ex.

Diversity Statement

Level Ex is the collective sum of all our individual experiences, backgrounds, and influences and we pride ourselves in growing and learning together. We are an Equal Opportunity Employer committed to building an inclusive and diverse environment where everyone's individuality is respected, and everyone has an Identity. Our commitment to inclusion across race, gender, age, religion, identity, and experience drives us forward every day.

No Agency or Recruiter submissions will be accepted .

Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job.

Socials

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Please be aware of scammers impersonating Level Ex recruiters. All email correspondence regarding jobs with Level Ex will come from a level-ex.com email address. If being contacted by someone with a levelex.works, levelex.careers, or any other email address it is fraudulent - please do not respond.