Clinical Trial Supply Chain Assistant
Oncopeptides, an innovative pharmaceutical company developing drugs for the treatment of cancer, are now looking to hire an outstanding Clinical Trial Supply Chain Assistant. The right candidate has a couple of years experience of working in a GCP environment and would thrive in a supportive role contributing to the successes of the Clinical Supply department. This is a chance for you to join an expanding company and dedicated team!
Oncopeptides has recently been granted accelerated approval by the U.S. FDA for PEPAXTO (melphalan flufenamide), in relapsed or refractory multiple myeloma. The company, which is listed on the Stockholm Stock Exchange, was founded in Sweden year 2000 and operates globally.
The position is full time and based in central Stockholm at Luntmakargatan. We will interview candidates continuously and welcome your application today.
As Clinical Trial Supply Chain Assistant you will be a part of the Clinical Supply team that consists of 10 people. The team oversee procurement, production, distribution of medicinal products to clinics globally for Oncopeptides’ Clinical Trials and Managed Access Programs. The Clinical Trial Supply Assistant (CTSA) will support the Clinical Supply departments compliance with GxP. The role includes management of internal clinical study documentation, e.g. prepare, distribute, file, and archive various documents. The CTSA will also support the internal project team by performing various administrative tasks, e.g. managing TMF files, returns, destructions, labels and the group’s training.
Main Responsibilities will include but are not limited to:
– Sorting, updating and performing quality check according to GCP on documentation to be filed in Trial Master File
– Investigational product label management and proofreading
– Management of returns to/from clinical sites to central depots.
– Liaising with CRO for management of returns and destructions.
– Contribute to SOP and work instructions development
– Assist with Reconciliation work.
– Processing of deviations
– Document tracking for QP Release and archiving of documents and study communications
– Compilation of regulatory approval documentation for Qualified Person release
– Appropriate filing and archiving of drug supply related documents on Sharepoint and Quality management system, Veeva Vault.
To fit the role you have a relevant degree and minimum two years of experience working in GCP environment. Experience with GMP and/or GDP is an advantage. You have experience from documentation filing and archiving and experience of handling of contract documentation / preparing tenders or quotations an advantage. Excellent computer and relevant software skills, especially Excel, and the ability to discuss complexities fluently in English and Swedish is a prerequisite. Experience of hospital pharmacy, pharmaceutical manufacturing, and distribution and/or clinical trial management is desired.
In this recruitment we put great emphasis on your personal potential and attitude. To be successful you have a well organised and thorough work routine, analytical mind and a pragmatic approach. You have a proven track record of working independently and in teams. You are a problem solver and are able to adapt to changing situations and take a diplomatic approach when discussing projects and problems. You are friendly, positive, and fun to work with and you enjoy actively participating in day-to-day operations and appreciate working in a fast paced, changing and time sensitive environment.
You are driven by the Oncopeptides Values; Science driven, Patient focused, Entrepreneurial, Collaborative, Passionate, Innovative, Courageous
Oncopeptides is a global biotech company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The company uses its proprietary peptide-drug conjugate (PDC) platform to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. The first drug coming from PDC platform, PEPAXTO®(melphalan flufenamide), has been launched in the U.S., for the treatment of adult patients with relapsed or refractory multiple myeloma. Melphalan flufenamide is evalu-ated in a comprehensive clinical study program including the global phase 3 studies OCEAN and LIGHT-HOUSE. Oncopeptides is developing several new compounds based on the PDC platform. The first one is expected to enter into clinical development in 2021.
Oncopeptides has approximately 300 coworkers. The global Headquarters is based in Stockholm, Sweden and the U.S. Headquarters is situated in Boston, Mass. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. More information is available on http://www.oncopeptides.com.
Poolia Life Science