Submission Specialist

Agency :

Havas Creative

Job Description :

Havas is looking for a full-time 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.

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Contract Type :

Permanent

Here at Havas across the group we pride ourselves on being committed to offering equal opportunities to all potential employees and have zero tolerance for discrimination. We are an equal opportunity employer and welcome applicants irrespective of age, sex, race, ethnicity, disability and other factors that have no bearing on an individual’s ability to perform their job.