Project Overview
We are the largest health advertising and communications organization in the world. We are individuals from around the globe, each bringing unique stories and
life experience, who share the same ambition: to help people live healthier, fuller lives.
Health is a uniquely powerful force which impacts our lives in every respect; us choices; our relationships; our ambitions; our impact on each other and the world. We believe helping people feel better is as much about uplifting the human spirit. as it is about treating the body and we help brands to do this by creating ideas and experiences that inspire that feeling. We are driven to create ideas that change the way people think about health. We strive to create work that connects with audiences on a deeper level. We are not afraid to tell the untold stories or speak unspoken truths. A simple principle shapes. our agency culture and our approach to building brands: to help each other thrive.
Job Summary
Havas is looking for a full-time Senior Submission Specialist to play a key role in supporting the operations team. The candidate will partner with project management, account, editorial, copy and junior submission specialist to ensure flawless project submissions in client platforms like Veeva, Zinc, MAP. We offer a positive, team-oriented environment and are looking for an experienced candidate that will be trained in our process. The Senior Submission Specialist will be responsible for working with the extended teams on the coordination and preparation of documents for submission to our client's medical, legal, and regulatory review panels. This
role will serve as the go-to expert on the client regulatory submission process and the systems/tools used for the submission. S/he will also be responsible for staying abreast of updates, creating/maintaining the
regulatory process binders and working with PMs to communicate updates to project teams.
You will work across several clients and brands and be responsible for supporting the project teams on ancillary activities as needed.
Responsibility
Works closely with project management, account, editorial, copy and junior submission specialists, to ensure all components of submission meet platform requirements.
- Become the expert on system requirements
- Be the primary point of contact for all submission needs and guidance
- Become the internal gatekeeper/QA for submission packages
- Attend initial/ongoing training updates on submission platform requirements
- Review job starter form, and project brief for accuracy
- Review mandatory items, PI, ISI, to ensure they are represented correctly
- Confirm file formats, naming conventions per guidelines
- Confirm all support materials are included, i.e., references, layout indicators, functional annotations
- Review tagging and linking of references in system to ensure accuracy
- Develop knowledge of reference library and expiration dates
- Collaborate with team to solve problems and resolve questions regarding submissions
- Continuously look to improve the process standards to ensure quality
- Partner with account team to compile a list of brand standard/global mandatories
- Maintain a submission calendar for brand team
- Understand OPDP submission requirements and complete QC checks
- Manage multiple submissions and deadlines
- Maintain accurate documentation
- Provide guidance to junior submission specialist as needed
Requirements
- 5+- years experience in pharma advertising with knowledge of regulatory review process. Strong planning and organization skills with extraordinary attention to detail.
- Excellent verbal and written communication skills and a basic comprehension of scientific content.
- Background in account management/project management ideal, but candidates with copy or editorial background could also be trained.
- Proficient with MLR Submission Platforms, Microsoft Office and Adobe Acrobat.
- Efficient, self- starter, quick study, flexible. Bachelor's Degree or equivalent experience required.
