MLR Manager

US-NC-Asheville
Category
Sale - Support
Everyday Health, Inc.
Type
Regular Full-Time

Overview

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 ProofHQ
  • 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
  • Maintains a comprehensive reference library for all products
  • Discretion: exercises good judgment with when to apply standards and when to leave alone

Subject Matter Expert within the Regulatory environment

Qualifications

  • 4 Year College Degree and/or equivalent experience
  • 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

 

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.

 

**Everyday Health is an Equal Opportunity Employer**

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