Document Quality Expert Clinical Development

About the PositionNovo Nordisk A/S is seeking an experienced Clinical Development Expert to drive the preparation of complex clinical documents and act as a project manager. As a key member of our Clinical Reporting team, you will play a crucial role in communicating scientific information to diverse stakeholders.The position requires a high level of...

About the RoleIn this exciting position, you will have the opportunity to make a difference in the lives of people participating in clinical trials by ensuring safe and high-quality products manufactured in compliance with legislation. Your key responsibilities will include ensuring best-in-class quality assurance of API for clinical trials in phase I, II,...

About the PositionWe are seeking a highly skilled and experienced Regulatory Document Specialist to join our team in Clinical Reporting. As a key member of our function, you will be responsible for driving the preparation of complex clinical documents and acting as project manager.Main ResponsibilitiesLead tasks such as planning, development, and oversight...

About the RoleWe are seeking an experienced Clinical Outsourcing Expert to support our Global Trial Portfolio projects. As an integral part of our team, you will be responsible for managing clinical contracting processes from request for information to signed contract. You will work closely with internal and external stakeholders to ensure seamless...

Job Overview:We are seeking an experienced Haematologist to lead our clinical development efforts. As a Medical Director, you will be responsible for providing strategic guidance and leadership to our teams, ensuring that our clinical trials meet the highest standards of quality and regulatory compliance.Key Responsibilities:Developing and implementing...

About Clinical Outsourcing ManagementClinical Outsourcing Management plays a vital role in supporting Novo Nordisk's Global Trial Portfolio projects. Our team works closely with internal and external stakeholders to drive and execute clinical trials worldwide. We are responsible for managing the clinical contracting process from request for information to...

Job DescriptionWe are looking for a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. As a member of our team, you will support CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.Your key responsibilities will...

About the RoleAt Novo Nordisk A/S, we are seeking a skilled and motivated Quality Assurance Expert to join our team. In this role, you will play a crucial part in ensuring patient safety by delivering high-quality standards for our products and production processes.The PositionAs an Aseptic Manufacturing Specialist, your primary task will be to review and...

Clinical Trial Submission RoleWe are looking for an accomplished Clinical Trial Submission Manager to lead the submission of initial Clinical Trial Applications (CTAs) and amendments to Health Authorities (HAs) and Ethics Committees (ECs). As part of our dynamic CTA Management department, you will work closely with various stakeholders across Development and...

About the Department:The Medical & Science department at Novo Nordisk A/S is responsible for developing and implementing clinical development strategies for our rare disease portfolio. As a member of this team, you will have the opportunity to work on high-impact projects that can make a significant difference in the lives of patients.Your Key...

Job DescriptionAs a Senior Clinical Project Lead, you will be responsible for end-to-end planning, execution, and completion of global trials. Your main responsibilities will include leading global cross-functional study teams, ensuring the trial team is well-functioning and effective, chairing of the trial squad, being overall accountable for the studies...

Job Overview">We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. The successful candidate will support CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.This role is part of our development...

RequirementsWe are looking for a highly motivated and experienced individual to join our team as a Senior Clinical Project Lead. The ideal candidate will have a strong background in clinical operations and a proven track record of delivering successful projects.You will be responsible for leading cross-functional study teams, driving clinical trials...

At Novo Nordisk, we are committed to creating innovative treatments for people living with serious chronic diseases. Our ambition is to ensure that patients' experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation.We are seeking a Clinical Outcome Assessment Specialist who will play a...

Job DescriptionWe are seeking a Senior Medical Writer - Regulatory Documents to join our Clinical Reporting team. The successful candidate will have a master's degree within natural sciences, preferably supplemented with a PhD and/or relevant experience in the pharmaceutical industry.Key responsibilities include:Planning, development, and oversight of...

About the DepartmentYou will join us in Clinical Reporting, part of Novo Nordisk Development and anchored together with Regulatory and Quality functional areas. We value continuous learning, being bold, and striving for simplicity.Main FocusCommunicate clinical data in a clear and concise manner.About the TeamClinical Reporting employs approximately 200...

Would you like to drive initiatives that innovate compliance procedures through digitalization and process improvement within the pharmaceutical industry? Do you want to be at the forefront of ensuring quality and compliance in handling clinical & research data and enhancing operational efficiency in a truly global organization?If so, then you might be the...

About the RoleThis is an exciting opportunity to join our Medical & Science team as a Senior Clinical Development Manager. As part of this role, you will be responsible for driving the planning and design of clinical studies, providing medical oversight during study conduct, and interpreting data to inform regulatory submissions.About Us:We are a global...

Are you an experienced Medical Writer looking to grow your career? If yes, then we would love to hear from you.The positionAs Medical Writing Specialist, your main responsibility is to drive the preparation of complex clinical documents and act as project manager. More specifically, you are expected to lead tasks such as:Planning, development and oversight...

Job Description:As a Quality & Compliance Partner, you will be responsible for overseeing quality and compliance initiatives related to data governance, ensuring adherence to data privacy regulations, and collaborating with cross-functional teams to optimize data practices.You will have the opportunity to drive initiatives that support the process for...