CTD (Common Technical Documentation) Planner

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Join our global Resource & Demand Planning Vaccines organisation as Common Technical Documentation (CTD) Planner and you will be responsible for the timelines, scheduling, coordination, and tracking of all contributing documentation for the CTD submission for First licensures for initial submissions and major variations under the scope of R&D (US/EU/CN/JP).  You will work closely with direct support to the Global Regulatory Lead, the Global Project Head and the Global Project Manager, also be a member of the core CTD Taskforce, attend to the CTD Satellite sub teams to ensure efficient tracking and on time submissions.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• 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.

About you

Experience:

• Knowledge of drug/ vaccine development & regulatory pathways.
• Knowledge of CTD structure/ Experience of a major filing.

Soft skills:

• Strong negotiation, communication and influencing skills.
• Project planning, time management and other project management skills.
• Problem solver with proactive mindset, able to prioritize and good with time management.
• Conflict resolution experience.

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.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment.
• Work from an "Office of the Year 2023" award winner with flexible home office policy.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks.
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs).

PursueProgress. DiscoverExtraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.