Regulatory Submission Specialist

2 miesięcy temu

Warsaw, Polska Publicis Le Pont Pełny etat

Job Description

As a Regulatory Submission Specialist, you will be responsible for researching medical documents, finding the correct references for pharmaceutical marketing assets, submitting this content into Veeva Vault platform and maintaining internal processes and project management. The role will be perfect for you if you have strong organizational and coordination skills, and a desire to work in a collaborative team environment. You should be able to work well in a rapidly changing, dynamic environment, and have excellent written and verbal skills.

Researching medical documents to reference digital marketing assets for Medical, Legal and Regulatory (MLR) review.  Liaising with cross-functional team members, specifically project managers to ensure there are clear communication lines and escalation pathways.  Submitting materials into Veeva Vault and submission platforms.  Adding any applicable annotations to submissions.  Ensuring timely submission of materials.  Maintaining familiarity with industry standards to ensure that documents meet or exceed regulatory requirements and guidance.  Monitoring timelines for assigned projects and updating the Program Leads if deliverables are at risk.  Reviewing and forwarding feedback from MLR team to internal Production teams for amendments.  Contributing to the development of process improvement tools and revisions of internal policies and procedures affecting submissions. 

Qualifications

Min. Bachelor’s degree in pharmaceutical or medical sciences.  1-2 years of pharmaceutical marketing or regulatory affairs experience.  Ability to understand and absorb scientific content, follow established timelines, expectations, priorities and objectives. Critical thinking.  Proficiency with various applications including Adobe Acrobat, Microsoft word, Excel, and PowerPoint. Exercises good judgement with defined procedures and policies to determine appropriate action. Strong attention to details and accuracy in work. Proactive team player with strong interpersonal skills. Takes ownership and drives positive, collaborative results.  Excellent written and verbal communication, planning and organizational skills. Ability to work under pressure, solutions oriented. Versatile and comfortable in a multitasking environment.  Knowledge of  Veeva Vault platform is a must.

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