Senior Clinical Drug Supply Associate (Hybrid)

Genmab

2+ years

$76,500.00---$127,500.00

Princeton Junction

15 June 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Clinical Drug Supply Associate

Company: Genmab

Location: Princeton, NJ, USA or Copenhagen, Denmark (Hybrid work arrangement)

Job Type: Full-time

Category: Clinical Operations

Post Date: 06/06/2024

Description:

Genmab is seeking a Senior Clinical Drug Supply Associate to join the Global Clinical Drug Supply Operations team in either Copenhagen or Princeton. In this role, you will play a central role in tasks related to packaging, labeling, and distribution of clinical trial supplies for early and late-stage clinical trials, as well as other programs for patients with cancer and other serious diseases. The position involves close collaboration with GMP QA colleagues and Contract Manufacturing Organizations (CMOs) to ensure timely execution of activities.

Responsibilities:

Create and review clinical labels from English Master Label to translation and proofreading.
Order products via CMOs and sourcing vendors for use in clinical trials in compliance with relevant legislation.
Review and approve Master Batch Records generated by CMOs to ensure cGMP compliance.
Maintain batch overview including batch release overview in alignment with Global Clinical Drug Supply Planning and GMP QA.
Evaluate temperature excursions reported by CMOs and clinical sites.
Perform batch reconciliation and oversee product destruction at CMOs.
Engage and collaborate with stakeholders such as GMP QA and CMOs/vendors for drug supply operations.
Support troubleshooting and execution of risk mitigation plans.
Train colleagues in Global Clinical Drug Supply Operations.
Support inspection and audit preparation and execution.
Participate in the maintenance of Standard Operating Procedures (SOPs).
Ensure compliance with Genmab's quality system.

Requirements:

Bachelor’s degree or equivalent.
Minimum 2 years of experience in handling clinical drug supply, including setting up label text, handling ancillaries, and distribution with cold chain management, preferably in Biotech or Pharma companies.
Experience working with CMOs for clinical trial supplies.
Knowledge of GMP, GDP, and GCP.
Proven experience working in teams.
Ability to work successfully under pressure in a fast-paced environment with tight timelines.
Proactive, enthusiastic, and goal-oriented.
Strong communication skills in English (both oral and written).

Application:

To apply, please upload your CV and cover letter, including your motivation for this position. Screening of candidates will be done on a continuous basis, and interviews will be scheduled accordingly.

Salary: For US-based candidates, the proposed salary band for this position is $76,500.00 - $127,500.00. The actual salary offer will consider factors such as skills, qualifications, experience, and location.

About You:

Passionate about Genmab's purpose and mission to transform the lives of patients through innovative cancer treatment.
Belief in a rooted-in-science approach to problem-solving.
Collaborative and team-oriented.
Determined to deliver excellence.
Comfortable with ambiguity and innovation.
Experience in a fast-growing, dynamic company preferred.

About Genmab: Genmab is an international biotechnology company focused on developing antibody therapeutics to improve patient lives. With over 20 years of experience, Genmab has a proprietary pipeline including bispecific T-cell engagers, immune checkpoint modulators, and antibody-drug conjugates. The company's vision is to transform the lives of people with cancer and other serious diseases with innovative antibody medicines.

Commitment to Diversity, Equity, and Inclusion: Genmab is committed to fostering workplace diversity and ensuring fair treatment for all applicants regardless of race, color, religion, sex, national origin, age, disability, or genetic information. Learn more about our commitments on our website.

Privacy Policy: Genmab is committed to protecting your personal data and privacy. Please see our privacy policy on our website for information on handling your data in connection with your application.

Note: For applicants in the Netherlands, please note Genmab's policy for initially offering fixed-term employment contracts, with the possibility of renewal for an indefinite term based on performance and business conditions.

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Senior Clinical Drug Supply Associate (Hybrid)

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