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Submission Specialist (MLR+EMA)

Submission Specialist (MLR+EMA)

OmnicomShimoga, IN
23 days ago
Job description

About Omnicom Global Solutions

Omnicom Global Solutions is an integral part of Omnicom Group, a leading global marketing and corporate communications company. Omnicom's branded networks and numerous specialty firms provide advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations and other specialty communications services to over 5,000 clients in more than 70 countries.

Omnicom Global Solutions India plays a key role for our group companies and global agencies by providing stellar products, solutions, and services in the areas of Creative Services, Technology, Marketing Science (Data & Analytics), Advanced Analytics, Market Research, Business Support Services, Media Services, and Project Management.

We currently have 4000+ awesome colleagues in Omnicom Global Solutions India who are committed to solving our clients' pressing business issues. We are growing rapidly and looking for talented professionals like you to be part of this journey.

Let's build this, together!

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.

Why Join Us?

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. Here’s what makes us unique :

  • We are a growing community that blends creativity, technology, and data-driven insights to transform healthcare.
  • Bringing you the best of both worlds – our team partners with key OH strategists while staying rooted in OGS’ culture and values.
  • Access to top healthcare and biopharmaceutical brands.
  • Helping you own your career – unlock diverse learning and upskilling opportunities, along with personalized talent development programs.
  • Empowering you with an inclusive, rewarding, and engaging work environment centred around your

well-being.

About our Agency Biolumina :

Biolumina is an oncology-focused, customer-agnostic, curiosity-driven communications agency. Biolumina is a full-service, omnichannel agency delivering customized, data-driven solutions for oncology brands. Our curiosity propels us to uncover truths and discover opportunities through a deep understanding of the science, the disease, and the key stakeholders and their emotional journeys. As a result, we build brand experiences that go beyond the rational to change behaviour and create brand loyalty

Know more at : https : / / www.biolumina.com / who-we-are

Job Details :

  • Oversee the end-to-end submission process of materials to the MLR review platform (Veeva Vault Promo Mats)
  • Understand and document client-mandated submission requirements and ensure these protocols are maintained with guidance from MLR / Submission managers
  • Create, uphold, and maintain submission checklists for assigned brands and ensure accurate and timely MLR submissions into Client systems
  • Maintain a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines
  • Annotate any notes / comments relevant to MLR reviewers onto the submission file (As required, for identifying derivative / pick-up content, or callouts for changes between reviews)
  • Perform QC of MLR submission components / package prepared by the team, before submission, and prepare and submit electronic and / or paper MLR-submission, including electronic tagging and linking references in Client system
  • Establish and build relationships with all internal cross-functional team members in collaboration with the Copy department, organize references to streamline project submissions
  • Support cross-functional team with opening projects in Client review platforms in collaboration with the Editorial team
  • Proofread / fact check against multiple source documents to confirm annotation accuracy
  • Stay current with new electronic submission and regulatory documentation practices and standards
  • This may be the right role for you if you have

  • 2-3 years of relevant work experience, preferably in science, medicine, or at a pharmaceutical advertising agency.
  • Bachelor’s degree in science, specifically related to medicine or pharmaceuticals
  • Demonstrated proficiency / mastery of English language
  • Excellent written and oral communication skills
  • Proficiency in Microsoft Office (Word, Outlook, Excel, PowerPoint) and Adobe Acrobat.
  • Familiarity with Veeva Vault PromoMats and / or Fuse and PubMed
  • Extremely detail-oriented and organized approach
  • Ability to work collaboratively with multiple departments and levels within the agency
  • Strong team-oriented approach and excellent interpersonal skills
  • Ability to thrive and grow in a fast-paced environment
  • Ability to prioritize deadlines and work under pressure.
  • A passion for sciences and regulations
  • Create a job alert for this search

    Specialist • Shimoga, IN

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