Biology dossier Coordination Manager (m/f/d), Lyon

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Missions

• Manage the European Regional Network of Dossier writers to ensure that high quality Biological Assessment Dossiers (BAD’s) are prepared on time for successful submissions to Authorities.
• Anticipate and coordinate the submission planning the incumbent needs and operate in coorperation with the Crop Leads/ ASM & Regulatory Sciences teams the planning developing and improving tools and database needed
• Manage resource needed in order to ensure the highest quality services in line with Budget management and implement the best solution and out-sourcing with external providers (CRO’s) for registration and re-registration
• Manage the preparation of a “product benefits” documentation (new text data base) as basis for the “Comparative Assessments” of products containing active ingredients classified by the EU authorities as “Candidates for Substitution”.
• As the EMEA expert for Biology dossiers advise on key KPI’s in experimental design of TDs / Protocols including statistics according to EPPO guidelines at the validation of strategic projects, advising on required needs to deliver high quality of bio-dossiers.
• Support the coordination of the outsourcing processes and resources management of trials as when required across the region with Contract Research Organizations (CRO’s)
• Ensure compliance with EPPO requirements of all the data and dossiers for submission.
• Lead and stimulate the transformation of the regional organization on Dossier requirements (digitalization ,format , content evolution), team evolution and resources managements
• Coordinate the collection and coordination needed for the construction of the CIR for FS

Profile

• At least 3-5 years of experience in different agricultural areas. Background and knowledge in agronomy, plant protection and testing practices
• Good experience in field trials issues (trial designs, biometrics /statistic knowledge)
• Fluency in digital/ transformation min 2-3 years , project management applied to regulatory, an experience in ARM would be a plus and UX or data science expertise too.
• Excellent demonstrated leadership and communication skills to influence and drive alignment across transfonctional and multinationals stakeholders
• Good written and oral communication skills
• Ability to evaluate and analyze large amounts of information and capacity to report information.
• Fluency in English is essential