You will be responsible for reference-linking, formatting, reviewing, and organizing scientific, promotional, and regulatory documents to meet submission requirements. You will ensure compliance with global standards, manage document workflows, perform quality checks, and maintain version control. This role is critical in supporting regulatory timelines and upholding documentation excellence for agency and client submissions.

- 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

Must-Have Qualifications &

Experience

- A bachelors 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).

- Robust 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.

Desirable Skills & Attributes

- 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

📌 Medical Writer (Bengaluru)
🏢 Omnicom Global Solutions
📍 Bengaluru