CTD (Common Technical Documentation) Planner

at  Sanofi US

• Job Title: CTD (Common Technical Documentation) Planner
• Location: Budapest
• Flexible working: 60% home, 40% office
• Job type: Permanent, Full-time

TECHNICAL SKILLS:

• Proficiency in project management software and tools.

Education:

• University degree in science or related discipline.

Languages:

• Excellent oral and written communication skills in English.

• In cooperation with the Global Regulatory Lead (GRL) members of the Global Regulatory Team and Global Project Manager (GPM), develop a comprehensive table of content listing all documents part of CTD.
• Develop a schedule for individual document draft, review, and approval, predecessor and successor logic and expected durations with the support of the Global Project Manager and the leaders of CTD satellite teams (e.g. clinical, non-clinical)
• Verify resource assignments for document preparation (to ensure the schedule is viable) and escalates resource issues to the core CTD Taskforce.
• Lead tracking efforts through effective schedule management, maintains status update reports for CTD satellite teams, sub-team leads, and CTD task force.
• Escalates resourcing and schedule problems and provide solutions as needed to remove impediments, resolve schedule conflicts, and meet document approval timelines.
• Provide support to coordinate the preparation of the Health Authorities answers to questions and updated relevant CTD modules if needed and ensure on time delivery of answers / updated CTD modules for submission of answer to questions.
• Evaluate and assess the document preparation and review results through effective metrics, tracking tools and lessons learned to inform future CTD preparation planning.