Job description
Agency :
Havas Health & You
Job Description Summary :
Job Summary:
The Senior Submission Specialist will partner with Project Management, Account Services, Editorial and Copy teams to ensure flawless project submissions in client platforms like Veeva, Zinc, MAP.
The Submission Specialist will be responsible for working with the extended team 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. The role will also be responsible for staying abreast of updates, creating/maintaining the regulatory process binder and working with PM’s to communicate updates to project teams.
This role is a combination of administrative and project coordination tasks. You’ll work across several clients and brands and be responsible for supporting the project teams on ancillary activities as needed.
Job Description :
Role & Responsibilities:
Work closely with Project Management, Account Services, Editorial and Copy teams, in reviewing all components of submission to ensure that platform requirements have been met.
- 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, project brief, and Stage II form for accuracy
- Review MAP codes and end matter
- 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
Skills & Experience Required:
- BS/BA degree in communications, liberal arts, business or marketing.
- 3-5 years of work experience in pharma advertising with knowledge of regulatory review process.
- Background in account management/project management ideal, but candidates with copy or editorial background could also be trained.
- Strong planning and organization skills.
- Proficient with Microsoft Office and Adobe Acrobat. Efficient, self-starter, quick study, flexible. Associates Degree or equivalent experience required.
Skills :
Accounting
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.
Due to high volume of applications, only eligible or matching candidates will be contacted by us.
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