Submission Specialist

18 hours ago

karnataka, India Omnicom Health Full time

Abo 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. 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. Our agency brands are consistently recognized as being among the world’s 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, BusinessThis 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 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

  • Regulatory Specialist, Submission Coordination; Sde, Lcm

    1 week ago

    Bangalore, Karnataka, India GlaxoSmithKline Full time

    Regulatory Specialist Submission Coordination works closely with global submission teams Local Operating Company regulatory contacts to deliver end-to-end submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices This role offers an excellent opportunity to develop...

  • Regulatory Specialist

    2 weeks ago

    Bangalore, Karnataka, India ScaleneWorks People Solutions Full time

    Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application pre-approval investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices May be responsible for leadership of relevant submission...

  • labeling specialist

    1 week ago

    Bengaluru, Karnataka, India, Karnataka Biocon Biologics Full time

    Regulatory Affairs Labeling Specialist roleKey Responsibilities:  Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products. Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team....

  • Documentation Specialist- Clinical Pharmacology

    2 days ago

    Bangalore, Karnataka, India AstraZeneca Full time

    Job Title Documentation Specialist- Clinical Pharmacology Safety Science Introduction to role Are you ready to dive into the world of clinical pharmacology and safety science As a Documentation Specialist you ll play a pivotal role in supporting regulatory submissions and reports within the Clinical Pharmacology and Quantitative Pharmacology CPQP department...

  • Nonclinical Document Specialist

    4 weeks ago

    Bangalore, Karnataka, India AstraZeneca Full time

    Job Title Nonclinical Document SpecialistIntroduction to role Are you ready to embrace new and varied opportunities to develop and learn As a Nonclinical Document Specialist you ll be part of the Nonclinical Submission group responsible for ensuring the technical quality and timely delivery of all nonclinical submissions You ll provide expert advice on...

  • Apply in 3 Minutes! Specialist, Business Development

    2 weeks ago

    Bangalore, Karnataka, India Fiserv Full time

    Calling all innovators - find your future at Fiserv We re Fiserv a global leader in Fintech and payments and we move money and information in a way that moves the world We connect financial institutions corporations merchants and consumers to one another millions of times a day - quickly reliably and securely Any time you swipe your credit card ...

  • [Immediate Start] Claims Resolution Specialist

    3 weeks ago

    Bangalore, Karnataka, India Transworld Systems Full time

    Overview Please Note English language proficiency is required for this role This is a full-time work from office role This requires a U S schedule - India Night shift Work Location This is a Work from Office position and location is Bangalore at Block 12B Pritech Park 3rd Floor SEZ Survey No 51-64 4 Bellandur Village Bldg 9A Rd Bengaluru...

  • Security Specialist

    1 week ago

    Bengaluru, Karnataka, India, Karnataka Nubra Full time

    Role Overview:We’re hiring a Security Specialist to safeguard our trading infrastructure, data, and systems. The role involves proactive threat monitoring, incident response, security audits, and ensuring regulatory compliance in a fast-paced trading environment.Key Responsibilities:Monitor & Respond to Threats: Continuously track security events across...

  • Hr Payroll

    2 weeks ago

    Bangalore, Karnataka, India AMETEK Full time

    Job Summary We are seeking a detail-oriented and experienced HR Operations Specialist to manage and process payroll general operations activities for our organization The ideal candidate will ensure accurate and timely payroll processing maintain compliance with relevant laws and regulations and provide excellent support to employees regarding HR...

  • Ar Caller

    6 days ago

    Bengaluru, Karnataka, India MedVoice Full time

    We are seeking a highly skilled and detail-oriented individual to join our team as a Medical Billing Specialist with solid **AR calling** experience. As a Medical Billing Specialist, you will play a crucial role in ensuring the accuracy and efficiency of our billing operations while maintaining compliance with regulatory requirements. **Role &...