Key Player in GMP Compliant Clinical Trials
4 days ago
Lundbeck is seeking a highly skilled Senior QP Delegate to join our CMC Development QA organization. As a key member of our team, you will play a crucial role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.
About the RoleIn this exciting opportunity, you will have a significant impact on our processes and contribute to the development of new innovative treatments for brain diseases. You will work closely with multiple stakeholders in CMC, regulatory affairs, commercial QA, and other departments to ensure seamless collaboration and effective communication.
Responsibilities- QP confirmation of Biologic Bulk Drug Substance and Drug Product
- QP certification of IMP
- QA assessment of deviations, change controls, and laboratory deviations
- Approval of master batch records
- Handling of complaints
To be successful in this role, you must have:
- A Master's degree in pharmacy or similar qualifications to meet the requirements of a QP Delegate
- Experience in biologic drug substance manufacturing
- At least 5-10 years of experience in a GMP regulated area either in Manufacturing, Quality Control, or Quality Assurance
- Previous experience as a QP delegate would be an asset
- Fluency in English
Lundbeck offers a unique position for you to build upon your experiences and professional development. This job offers great opportunities to grow your competencies and knowledge, and to widen your duties and responsibility as you develop in the role.
BenefitsLundbeck offers an inspiring workplace, passionate colleagues, and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.
You can also learn more about us at www.lundbeck.com or by following us on LinkedIn or Instagram (@lundbeck).
The salary for this role is approximately $80,000 - $110,000 per year, depending on experience and qualifications.
-
Clinical Manager for Clinical Trials
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is seeking a Clinical Manager for Clinical Trials to work with all aspects of clinical trial budget oversight, including budget development and vendor management support.The ideal candidate will have a solid understanding of clinical trial budgeting processes and procedures, as well as experience working with internal and external stakeholders.Key...
-
Clinical Trial Operations Director
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob DescriptionAt Genmab, we are seeking a seasoned leader to spearhead our clinical inspection readiness efforts. As the inaugural head of this function, you will be responsible for cultivating a high-performing international team dedicated to ensuring superior inspection readiness across our clinical trials.Key ResponsibilitiesTeam Leadership: Direct an...
-
Clinical Trials Director
1 month ago
Copenhagen, Copenhagen, Denmark MeetFrank Full timeAssociate Director, Global Clinical Trial ManagerAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. We believe that being proudly unique, determined to be our best, and authentic is...
-
Clinical Supply Chain Manager
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeClinical Drug Supply Manager Role SummaryWe 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,...
-
Clinical Supply Chain Manager
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe Clinical Drug Supply Manager role at Genmab involves overseeing the outsourcing of packaging, labelling, and distribution of clinical trial supplies for early and late-stage trials.The successful candidate will be responsible for managing stakeholders, setting up label text, and coordinating ancillaries, pre-medication, and comparators for clinical...
-
Clinical Trials Professional
1 day ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob Description:This role is ideal for a detail-oriented and organized individual with experience in clinical trial management. The Senior Clinical Trial Associate will be responsible for overseeing the filing of documents to ensure inspection readiness at the trial level.The role involves supporting the GCTM/CTM with key administrative activities, including...
-
Clinical Trial Management Lead
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe're seeking a clinical trial management expert to join our Development Program Management team at Genmab. As a key member of our Portfolio & Project Management department, you will lead the planning and execution of clinical trials from initiation to final reporting.Key ResponsibilitiesDevelop and implement clinical trial execution plans for assigned...
-
Clinical Trial Planning Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled Clinical Trial Planning Manager to join our Development Program Management team at Genmab. As a key member of our global Portfolio & Project Management department, you will play a pivotal role in advancing transformative therapies to patients.Key ResponsibilitiesDevelop and manage clinical trial execution plans...
-
Clinical Trial Planning Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled Clinical Trial Planning Manager to join our Development Program Management team at Genmab. As a key member of our global Portfolio & Project Management department, you will play a pivotal role in advancing transformative therapies to patients.Key ResponsibilitiesDevelop and manage clinical trial execution plans...
-
Clinical Trial Planning Manager
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled Clinical Trial Planning Manager to join our Development Program Management team at Genmab. As a key member of our global Portfolio & Project Management department, you will play a pivotal role in advancing transformative therapies to patients.Key ResponsibilitiesDevelop and manage clinical trial execution plans...
-
Senior Clinical Supply Associate
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled Senior Clinical Drug Supply Associate to join our Global Clinical Drug Supply Operations team in Copenhagen or Princeton. As a key member of our team, you will play a crucial role in the execution of tasks related to packaging, labeling, and distribution of clinical trial supplies for early and late-stage...
-
Clinical Trial Planning Manager
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout Clinical Trial Planning at GenmabGenmab is a leader in the development of innovative cancer treatments, and we are seeking a highly skilled Clinical Trial Planning Manager to join our team. As a key member of our Development Program Management team, you will play a pivotal role in advancing our transformative therapies from initiation to final...
-
Clinical Trial Associate
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeSenior Clinical Trial Associate - Regulatory Compliance SpecialistThe RoleThe Senior Clinical Trial Associate (CTA) will oversee the filing of documents (eTMF) to ensure inspection readiness at the trial level, supporting the GCTM/CTM with key administrative activities.Key ResponsibilitiesSetup, maintain, and close Sponsor eTMF (trial, country, sites, EDL,...
-
Senior Clinical Trial Associate
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob DescriptionThe RoleGenmab is seeking a highly skilled Clinical Trial Associate to join our team. This role is responsible for overseeing the filing of documents to ensure inspection readiness at the trial level and supporting the Clinical Trial Management team with key administrative activities.Key Responsibilities:eTMF Management:Setup and Maintenance:...
-
Clinical Drug Supply Manager
1 month ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the RoleGenmab is seeking an experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team in Copenhagen, Denmark or Princeton, New Jersey. 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...
-
Clinical Trial Planning Manager
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout Clinical Trial Planning Manager RoleAt Genmab, we're dedicated to developing innovative therapies for serious diseases and cancer. We're seeking a skilled Clinical Trial Planning Manager to join our team. As a key member of our Development Program Management team, you'll play a pivotal role in managing clinical trials from initiation to final...
-
Clinical Trial Planning Manager
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're driving innovation in cancer treatment and serious diseases by developing antibody products and pioneering therapies. As a Clinical Trial Planning Manager, you'll join our Development Program Management team, part of our global Portfolio & Project Management (PPM) department.This role is pivotal in managing clinical trials from initiation to...
-
Senior Clinical Trial Planner
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe are looking for a highly skilled Clinical Trial Planner to join our team at Genmab. The successful candidate will play a pivotal role in managing clinical trials from initiation to final reporting, ensuring alignment with our Global Development Operations (Dev Ops) colleagues.Responsibilities:Construct and monitor clinical trial execution plans for...
-
Clinical Trial Operations Manager
4 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a seasoned Senior Clinical Trial Associate to join our team at Genmab. As a key member of our Clinical Operations group, you will be responsible for overseeing the filing of documents to ensure inspection readiness at trial level and supporting GCTM/CTM with key activities.Key Responsibilities:eTMF Management:Setup, maintain and...
-
Clinical Trial Transparency Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe are seeking a skilled Clinical Trial Transparency Specialist to join our team at Genmab.About the Role:This role will be responsible for executing against global and national clinical trial disclosure requirements across our entire portfolio. You will support trial teams and applicable functions to ensure high-quality output and responsible disclosure of...