Regulatory Operations Coordinator

In the journey of life, your career should make a difference.

At Inizio Evoke, we come together—to do the best work, in the best possible place. We're all in. Because it's everyone's role to make health more human™.

About the role:

As a Regulatory Operations Coordinator at Inizio Evoke, you will become a valued member of our Regulatory Operations department. Your job will be to prepare submissions of promotional materials for medical, legal, regulatory (MLR) review by taking screenshots, annotating PDF files, cross comparing creative files with manuscript files and digitally routing files for internal approval. Our job is to support you in learning the skills to work in a fast paced, deadline-driven and high-volume advertising agency while gaining an understanding of the pharmaceutical advertising industry and the overall role of the agency. In this role, you will support the senior Regulatory team members by continuously moving quality-focused work through the department to be reviewed by our client MLR teams or funneled back through interagency disciplines. The Coordinator is detail-oriented, meticulously organized, and collaborates with other Coordinator for assistance with large volumes of work across the department. This is a fully remote role and can be based anywhere in the US. 

Responsibilities: 

• Manages multiple brand deadlines as a Shared Resource 
• Advises teams regarding timing and recommended submission strategies 
• Snagging/Screenshotting 
• Builds PDF review docs using SOPs for guidance 
• Transfers/copies functional and reference annotations 
• Writes functional annotations (as needed) 
• Maintains files/records of all stages of review 
• Organizes submissions documents on shared server 
• Server maintenance/clean-up 
• Monitors submission mailbox for relevant notifications 
• Downloads MLR comment files and sends path to team 
• Files approvals and sends path to team (2253, etc.) 
• Opens MLR job codes across varying client platforms 
• Uploads or submits any new reference materials provided by copy and/or MedEd 
• Gathers all documents needed for a submissions package 
• Set up, start, monitor and gain team approval on submission review routes 
• Uploads and submits materials for MLR review 
• Links references in Submission Platform (Vault) 
• Assist in preparation of OPDP binders as needed 
• Monitors archiving/digital asset upload process with internal team 
• Provides recommendations for improved submissions (i.e., formats and layouts) 
• Updates Project Dashboard and tracks submission dates for internal team 
• Update and maintain Shared Reg Ops excel sheet with upcoming and completed submissions
• Attend project Kick offs and review timelines as required by manager

Inizio Evoke provides an exciting and flexible work environment, great compensation packages and outstanding company paid benefits including medical, dental, 401(k), tuition reimbursement and flexible time off.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

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