Clinical Supply Chain Manager
2 weeks ago
We are seeking an experienced Clinical Drug Supply Manager to join our team at Genmab. As a Clinical Drug Supply Manager, you will be responsible for managing and coordinating drug supply and providing IMP for clinical trials, IST, and Pre-Approval Access Programs. You will also manage and coordinate ancillaries, pre-medication, and comparators for clinical trials.
**Key Responsibilities:**
* Manage and coordinate drug supply and 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 without 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.
**Requirements:**
* 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.
**Personal Requirements:**
* You can structure and organize your work.
* You are process oriented and contribute to continuous improvements.
* You have a quality mindset and can prioritize your work in a fast-paced and changing environment.
* You have good interpersonal and communication skills.
* You can work independently as well as within global teams.
* You are result- and goal-oriented and committed to contributing to the overall success of Genmab.
**About Genmab:**
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.
**Location:**
Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
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