Pharma Regulatory Specialist/Compliance Manager

Job ID 2021-2737

Other United States


Description

Position Summary:

At MedscapeLIVE! you will be responsible for overseeing and documenting the compliance process through MLR review and submissions related to our growing promo portfolio book of business. You’ll serve to facilitate the review cycle, including pre-review of materials, collaboration with audience engagement, content delivery, program and account management, reviews and sign-offs according to comprehensive and detailed brand guidelines and very strict deadlines. The applicant should be a highly organized individual with the ability to prioritize and excel in a deadline-driven environment.

 

What You’ll Do:

  • Proficiency in navigating a matrix organization, collaborating with multidisciplinary project teams, meeting client and management expectations, and ensuring programs remain on target and within agreed-upon parameters
  • Responsible for managing Medical Legal Review (MLR) submissions for a variety of Pharma Brand companies, including submitting in MLR Systems (Veeva Vault)
  • Develop and maintain constant knowledge of pharmaceutical company requirements, including but not limited to system and regulatory guidance and annotation guidelines
  • Provide consultation and guidance to Account Managers on all MLR submission formats, with an eye on keeping programs aligned with Medscape Submissions Best Practices
  • Work with internal teams to educate them on client submission requirements in order to execute high-quality MLR submissions
  • Monitor day-to-day project tasks, identifying potential areas for delay and actively work with to identify and troubleshoot issues
  • Escalates day-to-day task-related issues, acceleration, and prioritization requests to the Account Manager, Live Events
  • Champion internal systems (i.e. Workfront) and processes for higher productivity
  • Develop and maintain constant knowledge of Medscape Product offering and process as it relates to submissions and Pharma regulatory requirements
  • Participate in special projects as assigned

Who You Are:

  • Comfortable in a highly deadline-driven environment, and able to pivot quickly between tasks and adapt to rapidly shifting priorities
  • Enjoys leveraging technology to make the job easier
  • Someone who excels at developing and fostering positive team dynamics
  • Someone who thrives in a liaison position to collaborate with content creation, audience engagement, project management, design and account management

 

Qualifications:

  • BA/BS or equivalent years of experience
  • The appropriate candidate will have 4+ years in project management or operations, and experience working in a high-volume, process-oriented environment with a focus on online content development preferred
  • 4+ years relevant experience working in pharmaceutical and/or healthcare marketing preferred, direct experience working within pharmaceutical company requirements a plus
  • Ability to work efficiently under tight deadlines and to handle sensitive and confidential information with discretion
  • Experience using online workflow management tools (i.e Workfront)
  • Must be able to handle multiple projects and consistently meet deadlines, working collaboratively with colleagues in Editorial, Content Management, Project Management and Account Management.
  • Strong problem-solving, written and verbal communication skills, and ability to troubleshoot issues independently before raising a flag to the other teams.
  • Exceptional organizational skills and the ability handle multiple tasks/responsibilities simultaneously
  • Ability to work extended hours to meet clients’ business needs, if needed