IOLAVORO Virtual

49651 - Clinical Drug Supply Manager (Copenhagen, Denmark)

49651 - Clinical drug supply manager (copenhagen, denmark)

addetto alla gestione degli approvvigionamenti

EURES Agenzia Piemonte Lavoro is looking for an experienced Clinical Drug Supply Manager to be part of Global Clinical Drug Supply Operations in Copenhagen, DK or Princeton, NJ in commuting distance to our office locations to work according to our hybrid work arrangement. 

Moving forward with many late-stage trials in pipeline, the Clinical Drug Supply Manager will be managing outsourcing of packaging, labelling, and distribution of clinical trial supplies for early as well as late stage Genmab clinical trials. The Clinical Drug Supply Manager will work closely with GMP QA and our CMOs ensuring timely packaging and labelling for our clinical trials as well as IST and PAA for patients with cancer and other serious diseases. 

You will be part of a highly competent team focused on packaging and labelling of supplies for clinical trials, working closely with the Global Clinical Drug Supply Planning team and our CMOs. 

 

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. 

The Clinical Drug Supply Manager must have extensive knowledge of cGMP and have a focus on the level of quality in work performed. 

The position reports to the Director of Global Clinical Drug Supply Operations based in Copenhagen. 

Responsibilities 

  • Manage and coordinate drug supply and to provide IMP for clinical trials, IST, and Pre-Approval Access Programs. 

  • Manage and coordinate ancillaries, pre-medication, and comparators for clinical trials. 

  • Set-up English Master Label, manage label translation with out vendor and approval of label proofs/designs. 

  • Manage set-up of distribution framework through service providers. 

  • Define appropriate drug supply activities at CMO necessary for providing drug supplies for clinical trials. 

  • Contribute to maintenance of SOPs and Work Instructions in the department. 

  • Perform training of other team members. 

  • Function as Subject Matter Expert within relevant areas. 

  • Responsible for being compliant with Genmab’s quality system. 

  • At least 3 years’ experience in handling clinical drug supply, including setting up label text and handling of ancillaries. 

  • Ability to manage stakeholders internally and externally. 

  • Experience working with CMO for clinical trial supplies. 

  • Training in GDP, GMP and GCP is a requirement. 

  • Experience working with IST and PAA from a Sponsor perspective will be an advantage. 

  • Excellent communication skills in English - both oral and written. 

PLACE OF WORK: This role is located in Copenhagen, Denmark.  

WORK CONDITIONS: Full time. Salary is according to collective agreement in Denmark and negotiated on basis of experience and qualification. 

:
30/06/2024
  • Danimarca

CONTRATTO A TEMPO INDETERMINATO
DA 1 A 5 ANNI (Requisito Obbligatorio)
FULL TIME

 

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If you are interested in this position, please e-mail your CV & Cover Letter in English to [email protected]

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