eCTD Publisher

Canopy Life Sciences; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

Canopy Life Sciences is seeking an eCTD Publisher responsible for end-to-end regulatory publishing from submission planning to delivery to global health authorities. The role combines hands-on eCTD publishing with project management, client consulting, team coordination and commercial oversight.

The candidate will handle email communications with clients, manage files via FTP, perform PDF publishing with bookmarking and hyperlinks, and compile eCTD submissions for EMA, FDA, MHRA and Health

Qualifications

• Minimum 2 years of eCTD publishing experience.
• Experience with IQVIA eCTD RIM.
• Proficient in MS Word and Excel.
• Strong eye for detail and accuracy.

Responsibilities

• Check emails from clients and acknowledge receipt.
• Download files from FTP and upload to systems.
• PDF publishing with bookmarking and hyperlinks for eCTD submissions.
• Compile eCTD submissions for regulatory authorities.

Skills

eCTD Publishing

Project coordination

Regulatory submissions

Attention to detail

Tools

IQVIA eCTD RIM

MS Word

MS Excel

Job description

The eCTD Publisher is responsible for regulatory publishing projects from submission planning through to successful delivery to global health authorities. The role combines hands-on eCTD publishing expertise with project management, client consulting, team coordination and commercial oversight, ensuring that projects are delivered to the required quality, deadlines and budget.

Responsibilities

• Check emails from clients and respond to acknowledge:

Files clients have sent to Canopy via email /files they have uploaded to FTP

Replacement files/pages

Regulatory queries they may have on their submissions

• Files loaded onto the FTP are downloaded
• PDF publishing (bookmarking/hyperlinking) to eCTD submission ready PDFs
• Compilation of eCTD submissions
• External hyperlinking on client submissions
• Validation of Submission using industry eCTD validation tools
• Upload submissions for client review
• Upload submissions to Health Authority Agencies via EMA/CESP/MHRA/FDA

gateways

• Attend daily Reg Ops team submission meeting, with status updates
• Work to submitting applications to authorities to strict daily deadlines
• Ability to adapt to client requirements/multiple eCTD projects (EMA, MHRA, FDA, Health Canada)
• Research Industry regulatory updates
• Keep up-to-date spreadsheet of client submissions and KPIs of submissions
• Write up and review the eCTD Submission processes as they evolve
• Always work with Canopy processes

Required experience:

• 2 years or more eCTD publishing experience
• IQVIA eCTD RIM
• MS Word & Excel
• Eye for detail and accuracy

Other experience:

• PDF Plug in Tools

This job description is not limited to the tasks described above and other tasks may be assigned that are deemed reasonable in respect to the role.