MLR Submissions – Senior Executive

Omnicom Global Solutions; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Omnicom Global Solutions in Bengaluru is seeking a Senior executive - Submission Specialist to lead reference linking, formatting, and review of scientific, promotional, and regulatory documents for regulatory submissions.

You will ensure compliance with FDA/EMA ICH standards, manage document workflows, and maintain version control across assets, collaborating with writers, medical reviewers, and cross-functional teams to meet tight timelines.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 4–6 years in MLR operations, regulatory document management or submission coordination.
• Experience with Veeva Vault PromoMats or FUSE workflows and QC processes.
• Knowledge of FDA, EMA and ICH guidelines.

Responsibilities

• Reference, compile, and format regulatory and promotional documents for submissions.
• Coordinate submission timelines with cross-functional teams to meet deadlines.
• Perform advanced QC checks including hyperlinking and metadata verification.
• Maintain version control, trackers, and document repositories.

Skills

Veeva Vault

FUSE

Regulatory submissions

Document QC

Adobe Acrobat Pro

Education

Life Sciences degree

Tools

Veeva Vault PromoMats

FUSE (Novartis CMS)

Job description

Omnicom Global Solutions (OGS) is an integral part of Omnicom Group, a leading global marketing and corporate communications company. Omnicom’s branded networks and specialty firms deliver advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations, and other specialized communication solutions to over 5,000 clients across more than 70 countries.

OGS India serves as a key global capability center for Omnicom, enabling its agencies and group companies with scaled delivery, specialized expertise, and integrated solutions. Our capabilities span Media, Data & Analytics, Technology, MarTech, Commerce, Business Support Solutions, Creative Production, Healthcare, and Strategy & Insights.

With a workforce of over 7,000 professionals in India, OGS continues to expand its capabilities and global impact, supporting the evolving needs of clients and agencies. We are committed to building future-ready talent and delivering high-quality, outcome-driven solutions.

OGS India continues to expand its scale and capabilities through the integration of additional global operations, further strengthening its position as a strategic solutions engine for Omnicom.

Let’s build what’s next.

Omnicom Health

At Omnicom Health, you're not just starting a job—you’re becoming part of something bigger. As one of the largest and most specialized global healthcare networks, we're dedicated to building the ideas and solutions of tomorrow.

Your career here is about growth, impact, and the chance to shape the future of healthcare. Every day, the work you do will contribute to a greater cause, making a real difference in people’s lives.

The OGS-OH partnership empowers some of the world’s iconic brands with Knowledge, Innovation, and Transformation. When you join, you become part of a dynamic team that delivers high-impact solutions in the healthcare marketing and communications space

JOB SUMMARY:

As a Senior executive - Submission Specialist, 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 elevate 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 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.
• 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)
• Editing & Document Control: Microsoft Word (Advanced Formatting), Adobe Acrobat Pro
• Optional Tools: Submission Trackers, Content Management Templates
• Preferred Certifications: Regulatory Submission (DIA), Basics of Regulatory Affairs (RAPS), eCTD or Veeva Platform Certificate