Clinical Compliance Manager

Job OverviewThe Senior Clinical Reporting Manager will lead a team of 7 dedicated employees, managing the global medical writing and clinical reporting function. This role is part of the Clinical Data Science management team and involves ensuring the fulfillment of Global Clinical Reporting commitments, contributing to a positive working environment, and...

About the Job:As a Senior Clinical Document Editor, you will be responsible for crafting high-quality, scientifically accurate documents that support our clinical development projects.Your Key Responsibilities:Edit and review complex clinical documents to ensure accuracy, clarity, and compliance with regulatory requirements.Collaborate with cross-functional...

Lead a Team of Medical WritersAs the Director for Clinical Reporting at ALK-Abello, you will oversee a team of 7 dedicated employees responsible for global medical writing and clinical reporting. Your leadership skills will be instrumental in ensuring the success of this function.Your Responsibilities Will Include:Managing the Clinical Reporting team to...

About the Company\ALK-Abelló, A,S is a leading pharmaceutical company in the field of allergy immunotherapy.\The Role\We are seeking a highly skilled Medical Writer to join our Clinical Reporting department, where you will work closely with key stakeholders to develop and implement clinical disclosure strategies.\Your Key Responsibilities\\Write and prepare...

About the Position:As a Clinical Content Lead, you will be responsible for developing and implementing content strategies that support our clinical development goals.Your Key Responsibilities:Develop and maintain high-quality, engaging content that meets the needs of our target audience.Collaborate with cross-functional teams to create comprehensive content...

Drive Clinical Reporting ExcellenceWe seek an exceptional leader to join our Clinical Reporting team as Director for Clinical Reporting at ALK-Abello. This individual will lead a team of experienced medical writers and be responsible for the global medical writing and clinical reporting function.Your Key Responsibilities Will Be:To manage the Clinical...

Job OverviewThis role involves maintaining a high level of compliance with internal and external regulatory requirements. You will be responsible for a wide range of tasks, including process optimisation, maintenance of Standard Operating Procedures (SOPs), regulatory requirements review, and support during inspections and audits.Your primary tasks will...

ALK søger en dygtig Quality Partner til at være ansvarlig for afdelingens GMP- og complianceopgaver og sætte niveauet.Som Quality Partner vil du være med til at sikre løbende forbedringer af GMP og compliance og være nøgleperson i forbindelse med audits og inspektioner.Jobbet indeholder både faglige og administrative opgaver, herunder deltagelse i...

Sr. Manager / Associated Director for Drug Substance Development Do you bring proven management skills from working in a development area and do you have a strong scientific background within Drug Substance Development? Join us on our exciting journey and become our new colleague in Pharmaceutical Development. The position Drug Substance Development is a...

Er du en struktureret, systematisk og analytisk person med erfaring i sikring af løbende forbedringer af GMP og compliance i en farmaceutisk virksomhed?Vi søger en kvalificeret Quality Partner til at være ansvarlig for afdelingens GMP- og complianceopgaver og sætte niveauet. Som Quality Partner vil du være med til at sikre løbende forbedringer af GMP...

Sr. Manager / Associated Director for Drug Substance Development Do you bring proven management skills from working in a development area and do you have a strong scientific background within Drug Substance Development? Join us on our exciting journey and become our new colleague in Pharmaceutical Development. The position Drug Substance Development is a...

About Us\ALK-Abelló, A,S is a pharmaceutical company dedicated to improving the lives of people affected by allergies.\The Role\We are seeking a Medical Writer to join our Clinical Reporting department, where you will work closely with key stakeholders to develop and implement clinical disclosure strategies.\Your Key Responsibilities\\Create high-quality...

Key ResponsibilitiesAct as a key point of contact for compliance-related mattersProvide guidance on regulatory requirements and best practicesMaintain and improve the Quality Management System (QMS)Manage projects aimed at enhancing the QMSHandle deviations and ensure timely resolutionDistribute relevant Quality DocumentsAs a member of our team, you will...

We are looking for a Manager of Pharmaceutical Operations who can inspire, mentor, and develop a team of experts in drug substance development. As a seasoned professional with a strong scientific background, you will lead our team in developing innovative solutions for protein and biologic development.The Manager of Pharmaceutical Operations will work...

Do you thrive in a collaborative environment where your medical writing expertise can shape clinical development? Would you like to join a dedicated and enthusiastic team of 7 medical writers in a growing company? Apply today! The position Clinical Reporting is a department within Global Clinical Development. We are a growing team of 7 dedicated and skilled...

Y-mAbs Therapeutics is a biopharmaceutical company dedicated to developing innovative treatments for cancer. We are seeking a highly skilled Senior Manager, GMP Global QA to join our Global QA team.About the PositionThe Senior Manager, GMP Global QA will be responsible for ensuring compliance with regulatory requirements and industry standards. This includes...

Are you interested in a challenging role that involves Marketing Authorisation responsibilities and opportunities to work globally across multiple cultures?We are seeking a full-time Quality Assurance Manager with GMP and GDP experience to support cross-functional collaboration at ALK Headquarters and with external partners and affiliates...

We are seeking a skilled Senior Manager, GMP Global QA to join our Global QA team at Y-mAbs Therapeutics. As a member of our organization, you will contribute to the development and commercialization of cutting-edge therapies to treat various cancers.Job OverviewThe Senior Manager, GMP Global QA will be responsible for maintaining and improving our company's...

Du søger et job, hvor du kan bruge dine kvalitetskompetencer til at sikre et højt niveau af quality management og compliance? Har du erfaring fra en farmaceutisk virksomhed og produktion, og ønsker du at bidrage til at opretholle ett højt niveau af sikkerhed og kvalitet i vores produktion?Arbejdet som GMP Supporter indebærer forskellige opgaver,...

ALK-Abelló A/S is a health-focused organization that values pioneering spirit, credibility, and collaboration. As the Leader of Biologics Development, you will play a critical role in shaping our company's future by leading the development of robust and scalable drug substance processes.Our Leader of Biologics Development will have a minimum of 7 years of...