Submission Specialist (MLR / FDA+EMA)

JD:-

Submission Specialist (MLR+EMA)

About US

We are an integral part of Annalect Global and Omnicom Group, one of the largest media and advertising agency holding companies in the world. Omnicoms 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. Our agency brands are consistently recognized as being among the worlds creative best.

Annalect India plays a key role for our group companies by providing stellar products and services in areas of Creative Services, Technology, Marketing Science (data & analytics), Market Research, Business Support Services, Media Services, Consulting & Advisory Services. We are growing rapidly and looking for talented professionals like you to be part of this journey. Let us build this, together!

This is an exciting role and would entail you to

• 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
  

You will be working closely with

Our global medical communication agency teams. You will also be closely collaborating with our team of talented and designers to deliver high-quality services.

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.
• Bachelors 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