Overview
At DDB Health, we believe health can’t wait. The pace of healthcare is accelerating-and we love it. That is why at DDB Health, we DARE TO DO BOLDLY. We believe there’s nothing more important than health, and we need to stay a step ahead in order to achieve it. Our agency of courageous, curious, generous and gritty people are committed to solving the toughest health challenges. Through our omnichannel creative approach, we inspire our customers to take bold action that advances health.
Inclusivity:
We, at DDB Health, are an inclusive home. We believe that every voice matters, and we aim to reflect the world around us. Together, we can boldly tackle every health communication challenge with diverse thought and enhanced perspective.
Flexibility (new):
At DDBH we have a flexible hybrid working environment with employees able to split their time between the Soho headquarters and their home office, Friday afternoons free of meetings, Summer Fridays, and other perks and arrangements that enable our people to do their best work. We strive to be our boldest and best no matter where we are each doing our work – either with our clients, from home, or from the office.
DDB Health is a global network of healthcare communications companies dedicated to helping clients use creativity-and creative technology-as a force for good health. Through deep insight into customers, channels, and behavior, DDB Health creates meaningful change on behalf of important healthcare brands.
Title: Director, Submissions Specialist
Department/Discipline: Project Managment
Company/Location: DDB Health
Responsibilities:
- Managing Supervisor of content experts while assisting in preparation of the content of submissions to regulatory review teams for 3 OHG companies
- Manage submission process for electronic submissions, including:
- Tracking of new information/documents to be submitted and status of processing
- Supervising the preparation of documents for electronic submission (e.g., conversion to pdf, addition of bookmarks and hyperlinks).
- Performing QC of submission components prepared by team prior to submission
- Executing electronic filing for medical/legal/regulatory submissions
- Compiling regulatory compliant submissions in the required formats
- Stay current with new electronic submission and regulatory documentation practices
- Manage multiple submissions and deadlines
- Maintain accurate documentation
- Perform related duties as required
Qualifications & Experience:
- Experience with pharmaceutical promotions submission process (FUSE) is a MUST have
- Experience with the Novartis client is a Must have
- 8+ years of experience in the pharmaceutical/agency industry
- Has experience leading a team of Submission Specialists
- Excellent written and verbal skills, with the ability to listen, articulate, and advocate
- Ability to identify compliance risks and escalate when necessary
- Proficient in systems such as VEEVA
- Exhibit positive, constructive, decisive demeanor
Need to hire in the tri-state/local to NYC area for hybrid/office work model
The range below represents the low and high end of the base salary someone in this role may earn as an employee of an Omnicom Health Group company in the United States. Salaries will vary based on various factors including but not limited to professional and academic experience, training, associated responsibilities, and other business and organizational needs. The range listed is just one component of our total compensation package for employees. Salary decisions are dependent on the circumstances of each hire.
- $115,000 – $130,000
Omnicom Health Group is committed to hiring and developing exceptional talent. We agree that talent is equally distributed, and we’re focused on developing diverse teams that can bring the best solutions to everything we do. We strongly believe that celebrating what makes us different makes us better together. Join us-we look forward to getting to know you.