Regulatory Operations Coordinator

Job not on LinkedIn

🕒 April 15

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $58k - $65k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Inizio Evoke

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🤝 B2B

💊 Pharmaceuticals

🧬 Biotechnology

B2B • Pharmaceuticals • Biotechnology

Inizio Evoke is a global marketing and communications unit within the Inizio group that provides data-driven, creative, and omnichannel marketing and communications services to health and life sciences clients. It supports commercialization, product launches, congress experiences, and transformation initiatives, combining marketing expertise with scientific understanding and AI-enabled technology to drive growth and engagement for pharmaceutical and biotech organizations.

📋 Description

• 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

🎯 Requirements

• 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

• Inizio Evoke offers a fully remote work environment and outstanding company-paid benefits, including medical, dental, 401(k), tuition reimbursement, and flexible time off.