Note: The job is a remote job and is open to candidates in USA. Inizio Evoke is a global healthcare platform that aims to make health more human™. The Regulatory Operations Coordinator supports the department by managing brand deadlines, advising teams on submission strategies, and collaborating with other coordinators to handle large volumes of work.
Responsibilities
- Manage multiple brand deadlines as a Shared Resource
- Advise teams regarding timing and recommended submission strategies
- Snagging/Screenshotting
- Build PDF review docs using SOPs for guidance
- Transfers/copies functional and reference annotations
- Write functional annotations
- Maintain files/records of all stages of review
- Organize submissions documents on shared server
- Server maintenance/clean-up
- Monitor submission mailbox for relevant notifications
- Downloads MLR comment files and sends path to team
- Files approvals and sends path to team
- Open MLR job codes across varying client platforms
- Upload or submit any new reference materials provided by copy and MedEd
- Gather all documents needed for a submissions package
- Set up, start, monitor and gain team approval on submission review routes
- Upload and submit materials for MLR review
- Links references in Submission Platform (Vault)
- Prepare OPDP binders
- Monitor archiving/digital asset upload process with internal team
- Provide recommendations for improved submissions (i.e., formats and layouts)
- Updates Project Dashboard and tracks submission dates for internal team
- Update Shared Reg Ops excel sheet with upcoming and completed submissions
- Attend project Kick offs and review timelines as needed by manager
Skills
- Highly deadline-driven
- Adaptable and flexible, able to quickly adjust to shifting timelines, priorities, and client needs
- Strong multitasker who can balance concurrent projects without sacrificing accuracy or quality
- Detail-oriented with a sharp eye for consistency, compliance, and completeness across submission materials
- Proactive communicator who keeps teams informed and anticipates potential roadblocks
- Organized and process-minded, with the ability to manage complex workflows and documentation efficiently
- Comfortable working across multiple systems and platforms, with a willingness to learn new tools quickly
- Collaborative team player who can also work independently and take ownership of tasks
- Solutions-oriented mindset with a focus on improving processes and increasing efficiency
- Ability to remain calm and focused under pressure, especially during tight deadlines and submission cycles
Benefits
- Fully remote work environment
- Outstanding company-paid benefits, including medical, dental, 401(k), tuition reimbursement, and flexible time off
Company Overview
Inizio Evoke is a healthcare marketing, communications, and transformation platform for growth through data-driven insight. It was founded in 2009, and is headquartered in London, England, GBR, with a workforce of 1001-5000 employees. Its website is https://www.inizioevoke.com.