Senior Digital Life Science Consultant- (Regulatory Affairs)
Descrizione dell'offerta
Overview
LifeBee, is a ProductLife Group Company and leading international strategic and digital consulting firm, supporting Life Science companies in their journey towards digitalization, technological innovation, operational excellence, and proactive compliance. The focus is on the GxP regulated areas of Chemical, Bio-Pharmaceutical, Medical Devices, and Nutraceutical companies, particularly in Production, Quality Assurance, Laboratories, Logistics, Serialization, Industrial Operations, Regulatory Affairs, and Pharmacovigilance. ProductLife Group (PLG) is a dedicated life sciences outsourcing and consulting company. The group has its HQ in Paris and affiliates around the globe with teams in all key regions: North America, Europe and APAC. If you are passionate about Digital Transformation and Life Sciences and are keen to make an impact and lead international high‑profile customers through their digitalisation journey, you have read!
Your Role
According to your experience and expertise, you will have the ownership of and be responsible for increasingly complex activities aimed at the successful delivery of numerous projects, supporting both local and international clients in the Pharmaceutical and Life Sciences sector.
Responsibilities
- Advising customers, through frequent and close interaction, in analysing and designing the most suitable solutions to their needs so as to help them achieve their goals.
- Implementing, customizing and integrating market‑leading and cutting‑edge software applications for Life Sciences.
- Planning and executing project streams, drafting specifications, tests and validation technical documentation.
- Enhancing close collaboration with local and global software vendors.
- Providing added value to our customers, through qualified technical and functional support and training.
- Overseeing and supporting technical validation activities.
Qualifications
- STEM degree preferred (e.g., computer science, bioinformatics, computer engineering, biomedical engineering, mathematical engineering, statistics, physics).
- 2 years of relevant experience (or more) gained in a Consultant role.
- Knowledge of IT systems, coding languages, and MS Office productivity tools.
- Knowledge of Life Sciences Software solutions, regulations and guidelines.
- Analytical and problem solving approach.
- Fluency in Italian and English is required.
Nice to Have
- Knowledge of programming languages (e.g., SQL, Javascript, Python, C#).
- Knowledge of Industry (preferred in Life Science Market) Software Solution, particularly in RIMs, QMS, MES/EBR, BPM, LIMS, Workflow Management, Document Management, Business Analytics, Machine Learning, Artificial Intelligence.
- Knowledge of Regulatory software solutions such as Veeva RIMS (modules: Submissions, Submissions Archive & Registrations), Extedo RIMS ("Pulse"), Aris Global RIMS, Ennov.
Benefits
- Full‑time permanent employment contract.
- Hybrid working policy.
- Continuous technical and professional development training.
- Benefits package (welfare, private health insurance).
- Meal vouchers.
- Excellent internal growth opportunities.
- Competitive salary.