About Akkodis :
Akkodis, is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.
Akkodis is part of the Adecco Group. Our Webstite : www.akkodis.com
Context:
As part of the Center of Expertise Knowledge Management (CoE KM), we are seeking a CMC Technical Writer & Data Checker. This role is essential for managing the overall knowledge related to CMC products for designated (bio)pharmaceuticals. The successful candidate will be responsible for writing and verifying CMC documents, ensuring their compliance and integrity for regulatory submissions.
Missions:
* Write and maintain internal CMC documentation for new and existing (bio)pharmaceutical products.
* Manage and schedule the writing and review process with Subject Matter Experts (SMEs) to provide accurate and well-formatted information to Regulatory Teams.
* Ensure coordination with departments involved in the writing and review process.
* Monitor the compliance of supportive data used in CMC documentation, report significant issues, and resolve inconsistencies in data.
* Conduct data integrity checks for submission sections of Marketing Authorization Dossiers (NCE and NBE) and write or update Source Reports.
* Collaborate with CMC Product Management Leads to develop global knowledge management solutions and tools.
* Identify key information and knowledge needs to accelerate development projects and ensure submission readiness.
* Ensure effective communication among functional management, peers, key stakeholders, and TST members.
Profile:
* Master’s Degree in Life Sciences, Pharmaceutical Sciences, Regulatory Affairs, or related disciplines
* Previous experience in technical writing and data management within the pharmaceutical sector.
* Excellent writing and communication skills, with a keen attention to detail.
* Ability to work collaboratively with cross-functional teams and manage multiple priorities effectively.
* Knowledge of regulatory requirements and CMC submission processes.
* Skills in knowledge management and data management tools are a plus.
Why You Can't Refuse This Offer
As a member of the AKKODIS team, you will be:
* Onboarded into your role through a buddy process
* Supported in your career by your Business Manager
* An active participant in your training plan and personal and professional development
* Offered a permanent contract
* Provided with a competitive salary package that includes several extra-legal benefits.