Clinical Packaging Associate (full time job / permanent)
Helsinn is a fully integrated, global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and innovative pipeline of cancer therapeutics.
Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. It operates a unique licensing business model with integrated drug development and manufacturing capabilities. Helsinn has a commercial presence in 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners.
Helsinn plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth.
To learn more about Helsinn Group please visit www.helsinn.com
For our Drug Supply Team in Lugano, we are looking for a:
Clinical Packaging Associate (permanent contract/ full-time job)
- Define the drug packaging and labelling design considering regulatory requirements, financial implications and project timelines;
- Coordinate and negotiate drug procurement & supply plans with internal and external parties;
- Follow-up packaging and labelling activities, review and approve related documents;
- Control activities regarding drug supply budgets and invoices;
- Define the clinical trial material strategy and forecast for each clinical trial/clinical development program;
- Manage temperature excursion events during shipments and at the clinical sites in collaboration with CMC Managers and QA Managers;
- Reconcile (at country or depot level) study drug after study end liaising with the relevant CMO and CRO functions;
- To collaborate with QA to collect all needed information related to the drug in case of mock recall or recall in agreement with approved SOP.
- Manage other issues arising during the trial concerning drug packaging/labelling/supply/storage/collection.
- Issuing and review SOPs related to clinical trial materials lifecycle.
The successful candidate has the following qualifications:
- At least an internship in the field of Clinical Research.
- Previous experience in GMP or GCP quality or in GMP manufacturing area are a plus.
- Scientific Degree (Pharmacy, Biology, Biochemistry, etc.).
- Fluency in English, both written and spoken.
- Proficient use of standard informatics tools
- Analytical skills, accuracy and synthesis capabilities as well as organizational skills.
- Excellent relations with colleagues and functions outside the company, ability to work in teams as well as independently.
- Availability to travel.
Helsinn Healthcare SA is offering attractive conditions and a pleasant working environment in a highly motivated team.
Please send relevant application with CV to: