At Valesta we are continuously looking for experienced Pharmaceutical Consultants.
- Do you have a university degree in medical, biomedical or life sciences?
- Do you have a first experience in the pharmaceutical industry?
- Are you fluent in English?
Then you might be the candidate we are looking for. Don't hesitate and apply now!
Currently, we are actively seeking several kinds of profiles: Regulatory Affairs Associate, Team Lead Nurse, Clinical or Industrial Statistician, Health Economics Support.
Regulatory Affairs Associate
- Prepare, handle, distribute and file submissions to the Competent Authorities and Central/ Local Ethic committees
- Contribute to the life-cycle maintenance of existing registrations (MRP, DCP, National) by managing the variation dossiers and renewals
- Provide regulatory responses to health authority questions
- Build, manage and follow-up on the RA Systems and databases + Review the regulatory procedures
- Provide product and technical input into (new product) launch activities
- Responsible for the regulatory validation dossiers, including regulatory submission activities, and ensure a successful launch of new drug product manufacturing.
- Responsible for the management of the Packaging/Artwork flow and the coordination of the Artwork processes: development of artworks, external contact with suppliers and artwork agencies, follow-up of artwork approvals.
- Accountable for the internal and external communication so that the commercialized products are in line with the registration dossier
Team Lead Nurse
- Lead the clinical nursing staff through the execution of protocols and ensure complete adherence to protocol requirements
- Ensure that all study procedures are carried out following ICH GCP, scientific, medical, and ethical principles, within regulatory requirements/guidelines, and standard operating procedures
- Previous experience in Clinical Research is required
- Follow-up on training compliance
- Responsible for onboarding and training of new team members
- Temporary staff recruitment, follow-up and evaluation (people management experience required)
- Perform logistic tasks
- Provide, when requested, reference study nursing services with respect to correct protocol execution
- Organize and manage all clinical activities from screening to unit admission, ambulatory and follow up phases of a specific study
Clinical or Industrial Statistician
- Clinical Statistician: providing methodological support for the development, conduct and reporting of clinical studies and exploratory research projects (development of the initial concept, writing the statistical sections of the protocol, supervising database setup and cleaning, writing the statistical analysis plan, preparing the statistical analysis reports and contributing to the publication of results)
- Industrial Statistician: developing advanced statistical programs and providing statistical support to the to the Manufacturing and Quality organization. Collaborating with investigation and remediation/improvement programs regarding assay and process robustness. Advising on and developing new statistical methodologies to be used in support of Industrial Operations.
Health Economics Support
- Development of a consolidated core HE model
- Generation of a supportive model guidance
- Managing development of a model publication
- Development of a budget impact model and managing development of cost optimization model
- Country assistance in the process of customizing the core model to the local needs and requirements
- Strategy development.
- Project Management of health economics studies: day to day management of project execution until completion in terms of content, quality norms, timelines and budget control, Interim reports, Final report and presentation
- You have a University Degree in Life Sciences (Bachelor, Master) or a PhD in a relevant scientific field
- You have a previous experience in the same position
- Are you fluent in English? Fluency in French is an asset
- You have good communication skills and you are a real team player
- You are stress-resistant
- You have an eye for detail, you are quality-oriented and well-organized
Amandine Planche (RA Associate, Clinical/Industrial Statistician) & Mihaela Lascar (Team Lead Nurse & Health Economics Support)
+32 10 68 53 30