Submissions Specialist

Shobiz Experiential Communications

5 - 10 years

3 - 7 Lacs

chennai

Posted:1 day ago| Platform:

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Skills Required

adobe acrobat project management pharma legal packaging account management ms office advertising

Work Mode

Work from Office

Job Type

Full Time

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, ie, 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. bachelors Degree or equivalent experience required.

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