About This Role
This role is critical in supporting regulatory timelines and upholding documentation excellence for agency and client submissions. You will be responsible for reference-linking, formatting, reviewing, and organizing scientific, promotional, and regulatory documents to meet submission requirements, ensuring compliance with global standards, managing document workflows, performing quality checks, and maintaining version control.
Responsibilities
- Reference, compile, and format scientific, promotional, and regulatory documents for submission readiness, including presentations, email assets, digital materials, reference binders, and supporting documentation
- Manage asset uploads, linking, annotation, and audit trails within systems such as Veeva PromoMats & FUSE
- Maintain accurate version control, submission trackers, master files, reference libraries, and document repositories
- Coordinate with writers, editors, medical reviewers, regulatory teams, accounts teams, and project managers to track submission timelines and resolve document-related issues
- Identify and escalate formatting, compliance, or workflow risks that may impact submission timelines
- Contribute to the continuous improvement of submission processes, templates, QC checklists, and operational best practices
- Perform advanced QC reviews, including formatting validation, hyperlinking, cross-referencing, annotation checks, metadata verification, and document consistency checks
- Ensure compliance with FDA, EMA, ICH, client-specific templates, brand guidelines, and editorial style guides
- Collaborate with cross-functional stakeholders to track submission timelines and resolve formatting issues
Requirements
- A bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Biochemistry, or a related discipline
- 4–6 years of experience in MLR operations, regulatory document management, submission coordination, scientific content formatting, or document quality control
- Hands-on experience with Veeva Vault PromoMats or FUSE, including asset creation, referencing, annotation review, metadata management, certification workflows, and submission lifecycle activities
- Experience reviewing scientific claims, references, and promotional materials for submission and compliance readiness
- Strong understanding of global regulatory standards (FDA, EMA, ICH)
- Strong organizational habits and an eye for detail, compliance issues, and QC processes
- Proven ability to manage multiple submission activities simultaneously while maintaining high accuracy and attention to detail
- Advanced Microsoft Word formatting skills (styles, templates, section management, TOC generation, cross-references, and document troubleshooting)
- Strong proficiency in Adobe Acrobat Pro for QC review, commenting, hyperlink validation, and PDF document management
Nice to have:
- Excellent quality control and document validation skills with a strong focus on compliance and accuracy
- Ability to work on multiple deadlines, navigate deliverables, and follow submission timelines
- Strong communication and stakeholder management skills while working with cross-functional global teams
- Organizational skills with effective tracking, documentation, and version control practices
- Experience with end-to-end Veeva submission workflows across multiple asset types
- Exposure to digital, print, email, and interactive promotional assets
- Understanding MLR review comments, approval workflows, and comment resolution processes
- Experience supporting US pharmaceutical or global healthcare brands
- Familiarity with submission trackers, content management templates, and operational reporting
- Experience with FUSE (Novartis's CMS)
Essential Tools/Platform Certification
- Editing & Document Control: Microsoft Word (Advanced Formatting), Adobe Acrobat Pro
- Regulatory Platforms: Veeva Vault PromoMats, Aprimo FUSE
- Optional Tools: Submission Trackers, Content Management Templates
- Preferred Certifications: Regulatory Submission (DIA), Basics of Regulatory Affairs (RAPS), eCTD or Veeva Platform Certificate
