Submissions Publisher
We are seeking a detail-oriented and experienced Submissions Publisher to join our Regulatory Science team on a temporary basis. The ideal candidate will have extensive experience with Veeva RIM; RIM RLCP and Submissions Publishing, document management, and a strong understanding of FDA regulatory requirements.
What you’ll do:
- Document Management: Manage and maintain regulatory submission documents using Veeva RIM Vault, ensuring accuracy, consistency, and compliance with company standards.
- Submission Preparation: Compile, format, and publish regulatory submissions in accordance with FDA guidelines using Veeva RIM Submissions Publishing.
- Collaboration: Work closely with cross-functional teams, including Regulatory Science, Quality Assurance, Research and Development , Scientific and Regulatory Affairs, and Manufacturing to gather necessary documents and ensure timely submissions.
- Quality Control: Perform quality checks on submission documents to ensure completeness and compliance with regulatory standards.
- Regulatory Knowledge: Stay updated on FDA regulations and guidelines, and apply this knowledge to the preparation and submission of regulatory documents.
- Issue Resolution: Identify and resolve issues related to document management and submission processes.
Qualifications:
- Experience: Minimum of 3-5 years of experience in regulatory submissions publishing, with specific experience using Veeva RIM Vault (RLCP publishing / Submissions Publishing). Pharmaceutical FDA eCTD Submissions Publishing via other publishing platforms can also be considered.
- Document Management: Proficiency in document management systems, particularly Veeva RIM Vault.
- Regulatory Knowledge: Understanding of FDA regulatory requirements and guidelines.
- Attention to Detail: Strong attention to detail and organizational skills.
- Communication: Excellent written and verbal communication skills.
- Team Player: Ability to work effectively in a team environment and collaborate with cross-functional teams.
Preferred Qualifications:
- FDA Regulatory Experience: Direct experience with FDA submissions is a significant advantage.
- Technical Skills: Familiarity with electronic submission standards, Veeva, and eCTD/eTTD submissions publishing tools.
You as a person:
- You are fluent in English. A high standard of written English is mandatory. Other languages are a bonus
- You have great team spirit, can negotiate effectively, are self-motivated and driven and have strong communication skills
- You have excellent time management and organizational skills and have proven ability to work in a fast-paced, international, cross-functional environment
- You are dependable and focused on delivering high-quality outputs within tight deadlines
- You are comfortable working within a team or individually as required
- You enjoy working in a diverse people and culture environment and are happy to reach out to and collaborate with colleagues across the world