Regulatory Submission Specialist

2 tygodni temu

Warszawa, Mazovia, Polska Publicis Le Pont Pełny etat

Job Description

As a Regulatory Submission Specialist, in this role, you will be tasked with delving into medical documents, pinpointing the correct references for pharmaceutical marketing materials, uploading content onto the Veeva Vault platform, and overseeing internal processes and project management. This position is ideal for individuals with top-notch organizational skills, coordination abilities, and a penchant for thriving in a collaborative team setting. You must be adept at handling a fast-paced, ever-evolving environment while possessing exceptional written and verbal communication skills.

  • Researching medical documents to reference digital marketing assets for Medical, Legal, and Regulatory (MLR) review
  • Liaising with cross-functional team members, particularly project managers, to maintain clear communication channels and escalation protocols
  • Uploading materials onto Veeva Vault and other submission platforms
  • Including relevant annotations in submissions
  • Ensuring timely submission of materials
  • Staying abreast of industry standards to guarantee document compliance with regulatory requirements and guidelines
  • Tracking project timelines and informing Program Leads of any potential delays
  • Reviewing and relaying feedback from the MLR team to internal Production teams for necessary revisions
  • Contributing to the refinement of process enhancement tools and updates to internal policies and procedures influencing submissions

Qualifications

  • Minimum of a Bachelor's degree in pharmaceutical or medical sciences
  • 1-2 years of experience in pharmaceutical marketing or regulatory affairs
  • Proficiency in comprehending and assimilating scientific content, adhering to established timelines, expectations, priorities, and objectives. Possessing critical thinking skills
  • Skilled in various applications such as Adobe Acrobat, Microsoft Word, Excel, and PowerPoint
  • Exercising sound judgement within defined procedures and policies to determine appropriate courses of action. Demonstrating keen attention to detail and precision in work
  • Dynamic team player with strong interpersonal skills. Shows initiative, fostering positive and collaborative outcomes
  • Excellent written and verbal communication skills, coupled with effective planning and organizational abilities
  • Capable of working under pressure, adept at problem-solving. Adaptable and proficient in multitasking environments
  • Proficiency in Veeva Vault platform is essential

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