Drug Supply Associate (temporary contract/ full-time job - based in Lugano)

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 – Clinical Operations & Services - in Lugano, we are looking for a:

 

Drug Supply Associate (temporary contract/ full-time job - based in Lugano)

 

Responsibilities include:

 

  • Define the drug supply strategy and forecast for each clinical trial/clinical development program;
  • Define and submit study drug requests internally to the CMC Department
  • Define the drug packaging and labelling design also considering regulatory requirements, financial implications and project timelines;
  • Coordination and negotiation of drug procurement & supply plans with internal and external parties;
  • Define the investigational sites supply and re-supply roles and strategies;
  • Follow up of packaging and labelling activities, review and approval of documents;
  • Collaborate with other HHC and HBP departments for providing the necessary documentation for batches release according to the existing SOPs;
  • Contribute to the IWRS set up in collaboration with the dedicated functions, as far as the drug supply is concerned;
  • Global reconciliation (at country or depot level) of study drug accountability after study end, liaising with the relevant CMO and CRO function;
  • Involvement in any other critical issue arising during the trial concerning drug packaging/labelling/supply/storage/collection.

 

 

The successful candidate has the following qualifications:

 

  • At least an internship in the field of Clinical Research.
  • Scientific Degree (Pharmacy, Biology, Biochemistry, etc.).
  • Knowledge of relevant GxPs and of applicable multinational regulations.
  • 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.