Bio Dossier Writer

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Job Purpose:

Combines the field solutions (technical) and regulatory science disciplines, driving the strategic alignment between technical (field data) and regulatory guided documentation towards a well-placed BioDossier document for successful Crop Protection product application.

Task and Responsibilities:

1. Major Tasks As Bio Data Manager (80%):
2. Operate as a cluster expert for Biology dossiers by advising on experimental design of trials/protocols including statistics according to local guidelines at the start of projects.
3. Advise on adequate synthesis of data extracted from local data management systems (SCOUT) including reliable statistical analysis as a basis for the delivery of high-quality bio-dossiers.
4. Write high-quality Biological dossiers (BAD) for submissions in African countries according to local guidelines, using data extracted from local reporting systems (SCOUT). Ensure compliance with local requirements in the presentation of the data and dossiers for submission.
5. Contribute to the GAP creation/harmonization process by being the focal point between Regulatory and Development expertise; ensure consistency of the defined GAPs during the creation of the data set and the redaction of the related BADs/DRR.
6. Contribute to the overall harmonization process of having common methods for testing effectiveness of the projects and also harmonization in the way the data have to be presented in the dossiers now meeting common African requirements.
7. Write addendum for possible national requirements (National Addendum).
8. Be able to write argumentation and/or extrapolation with or without data.
9. Monitor locally the outsourcing of high-quality dossiers to external providers (CROs) in the frame of re-registration and the management of peak activities according to local strategies.
10. Develop local expertise in the frame of new requirements such as comparative assessment and the documentation on the benefits of our solutions.
11. Support the local member of the regional data management network and the country key user in developing dedicated routines needed for BAD/DRR writing purposes.
12. Be an additional trainer for the local internal and external organizations (Research Institutes, External Contractors) working for the company and having access to local data management systems.
13. As Quality Assurance Manager (20%):
14. Coordinate and participate in the activities related to the audits of local regulatory bodies, being responsible for carrying out the corresponding corrective actions emanating from them.
15. Carry out critical phase inspections in previously agreed residue trials and programmed with the corresponding inspection plans. Carry out general and special inspections of the different test sites.
16. The detected deviations will be previously discussed with the field IP and documented accordingly.
17. Assist Agronomic Excellence with knowledge transfer for a smooth transition from registration trials to demonstration trials.
18. Contribute to new product and Business Excellence initiative launch plans by ensuring the transfer of product expertise to maximize market penetration and profitability quickly.

Qualification and Skills Required:

Degree in agriculture or equivalent with at least 2 years of experience in agricultural areas.

Background and knowledge in agronomy, plant protection, and testing practices.

Good experience in field trials issues (trial designs, biometrics/statistic knowledge).

Excellent analytical and IT skills.

Familiar with data science processes and tools.

Good organization and planning skills.

Location:

Division: Crop Science

Reference Code:

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.