- Creation and review related to setup of clinical labels from English Master Label to translation and proof reading.
- Order products via CMOs and sourcing vendors for use in clinical trials as per relevant legislation.
- Review and approve Master Batch Records generated by our CMOs to ensure compliance with cGMP.
- Maintain batch overview including batch release overview as per alignment with Global Clinical Drug Supply Planning and GMP QA.
- Evaluate temperature excursions reported by our CMOs and clinical sites.
- Perform batch reconciliation and oversee destruction of product at our CMOs.
- Stakeholder engagement and collaboration related to drug supply operations e.g., GMP QA and CMOs/vendors for packaging, labelling and distribution.
- Support trouble shooting and execution of risk mitigation plans.
- Train colleagues in Global Clinical Drug Supply Operations.
- Support inspection and audit preparation and execution.
- Participate in maintenance of SOPs.
- Responsible to be compliant with Genmab ́s quality system.
- Minimum of a Bachelor's degree or equivalent.
- Advantage with 2+ years' experience in handling clinical drug supply, including setting up label text, handling of ancillaries, distribution with cold chain management from CMO, Biotech or Pharma companies.
- Experience in working with CMO for clinical trial supplies.
- Knowledge and understanding of GMP, GDP, and GCP.
- Proven experience working in teams.
- Ability to work successfully under pressure in a fast-paced environment and with tight timelines.
- Ability to be proactive, enthusiastic, and goal orientated.
- A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support the execution of tasks.
- Strong communication skills in English - both oral and written.
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
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Senior Clinical Drug Supply Associate - Copenhagen, Danmark - Genmab
Beskrivelse
The Role
& DepartmentGenmab is searching for an enthusiastic Senior Clinical Drug Supply Associate to be part of Global Clinical Drug Supply Operations in Copenhagen or Princeton within commute distance from our office locations to work according to your hybrid work arrangement.
Having an impressive pipeline and many ongoing clinical trials, you will have a central role in the execution of tasks related to packaging, labelling and distribution of clinical trial supplies for early as well as late-stage clinical trials, IST, and PAA for patients with cancer and other serious diseases.
This is done in close collaboration with GMP QA colleagues and our CMOs ensuring timely execution. All manufacturing activities are outsourced, and you must be skilled in professional and clear written and oral communication to ensure activities are carried out as per expectation.
You must be an initiative driven and proactive player with responsibility to deliver high quality trial supplies on time from an operational perspective. Changes are a natural part of our work, so you are able prioritize your tasks and balance importance with urgency.
The position reports to the Global Clinical Drug Supply Operations Lead based in Copenhagen.
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.
Together with Global Clinical Drug Supply Systems team, the three teams make up the Global Clinical Drug Supply department.
We have an international and informal working environment with a high pace while having fun and focus on one team spirit both within and outside the team and department.
Responsibilities
Requirements – what you must have
Where you will work
This position will work from our Princeton, NJ USA or Copenhagen, Denmark office locations and is hybrid. Fully remote applicants will not be considered, so please indicate if you are willing to relocate if you're not currently living in commute distance.
Application
Has this sparked your interest? Then we encourage you to upload your CV and cover letter including your motivation for this position. We screen candidates on a continuous basis and call in for interviews.
For US based candidates, the proposed salary band for this position is as follows:
$76,.00---$,.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
About You
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
