Clinical Drug Supply Manager
1 month ago
We are seeking an experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team in Copenhagen, DK or Princeton, NJ. As a key member of our team, you will be responsible for managing the outsourcing of packaging, labeling, and distribution of clinical trial supplies for early and late-stage Genmab 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.
- 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.
We are looking for a passionate and dedicated individual who is committed to our purpose of transforming the lives of patients through innovative cancer treatment. You should have a strong background in clinical drug supply and be able to work independently as well as within global teams.
As a member of our team, you will have the opportunity to work on a wide range of projects and contribute to the development of new antibody therapies. You will be part of a highly competent team focused on packaging and labeling of supplies for clinical trials, working closely with the Global Clinical Drug Supply Planning team and our CMOs.
We offer a dynamic and informal working environment with a high pace while having fun and focusing on one team spirit both within and outside the team and department.
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Clinical Drug Supply Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking an experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team in Copenhagen, DK or Princeton, NJ. As a Clinical Drug Supply Manager, you will be responsible for managing the outsourcing of packaging, labeling, and distribution of clinical trial supplies for early and late-stage Genmab...
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Clinical Drug Supply Manager
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking an experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team in Copenhagen, DK or Princeton, NJ. As a key member of our team, you will be responsible for managing the outsourcing of packaging, labeling, and distribution of clinical trial supplies for early and late-stage Genmab clinical...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking an experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team in Copenhagen, DK or Princeton, NJ. As a key member of our team, you will be responsible for managing the outsourcing of packaging, labeling, and distribution of clinical trial supplies for early and late-stage Genmab clinical...
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