MLR Manager - Everyday Health

Creative Services Asheville, North Carolina


Description

Position at Everyday Health

The MLR Manager is a key client-facing role responsible for shepherding branded communications through rigorous internal development and Q&A culminating in client submission and review processes.

RESPONSIBILITIES:

Serves as the key MLR Manager for select accounts and is responsible for day-to-day guidance and implementation of projects through the approval and triage process. This position will ensure quality and consistency at the development and review stages of projects.

  • Reviews creative revisions to copy and final art to ensure materials meet OPDP requirements thereby exceeding client expectations
  • Establishes and oversees compliance with brand and positioning for correctness, consistency and completeness in association with content/claims and fair balance
  • Prepares, annotates, monitors and submits regulatory filings and documents using advanced knowledge of client regulatory standards and submission requirements
  • Evaluates adequate presence and size of fair balance in relationship to claims being made
  • Accountable for submission readiness that includes substantiated claims, referencing and annotations
  • Verifies accuracy and acceptance of references to conform to AMA Style Guide
  • Maintains a knowledge base regarding FDA Regulations
  • Writes, updates, and distributes to product team members-specific brand guidelines, incorporating client medical/legal/regulatory requirements and feedback
  • Understands clients regulatory submission process and timelines
  • Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes, and coordinate regulatory compliance activities at a global level
  • Reads creative briefs and understands the purpose/intent
  • Reads appropriate subject matter to further understand disease state to assist in content management
  • Participates and leads the facilitation with key stakeholders and provides support for solutions, alignment and consensus
  • Provides promotional guidance and expertise to drive quality, consistency, and speed of projects
  • Works with Traffic Coordinator to provide timelines to team via Ziflow annotations system
  • Checks graphs, charts and tables to ensure data is displayed clearly, correctly and mathematical calculations are accurate
  • Proactively address issues, gaps, options for an optimal and timely submission and approval
  • Discretion: exercises good judgment with when to apply standards and when to leave alone
  • Subject Matter Expert within the Regulatory environment

QUALIFICATIONS/REQUIREMENTS:

  • 4 Year College Degree
  • Project Management Skills/Training
  • Extremely detailed oriented
  • Ability to juggle multiple priorities and deadlines
  • Self-Directed
  • Articulate and confident in both written and verbal communications
  • Ability to work under tight deadlines with positive attitude
  • Tech savvy; able to navigate submission systems

The most important skills required are concerned with self-motivation, team-work, prioritization and the management of diverse tasks.  This person must have the ability to work under pressure, utilize effective time management and organization client-focus and a willingness to take ownership of projects.

The most important attributes required include pro-activity, enthusiasm, commitment, an orientation towards achieving results/fulfilling objectives, and having the drive to succeed.

COMPANY PROFILE

We are a leading provider of digital health and wellness solutions. We attract a large and engaged audience of consumers and healthcare professionals to our premier health and wellness properties. We enable healthcare professionals to stay informed and make better decisions for their patients, and marketers, health payors and providers to communicate and engage with consumers and healthcare professionals to drive better health outcomes. Our content and solutions are delivered through multiple channels, including desktop, mobile web, and mobile phone and tablet applications, as well as video and social media. We are committed to empowering and inspiring people to live their healthiest lives every day.

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