Experienced Medical Writer for Regulatory Affairs

About the Role:Pharma IT is seeking experienced Senior/Principal Medical Writer Consultants to join our Regulatory Affairs & Medical Writing Team. As a consultant, you will work with clients in the pharma, biotech, and medical device industries.Responsibilities:Write and review clinical documents for regulatory submissions in the EU and US.Participate in...

About the RoleAscendis Pharma is a fast-growing biopharmaceutical company with a global presence. We are seeking an experienced professional to lead our external programs in Global Medical Affairs.The ideal candidate will have 4-7 years of experience in project management within medical affairs, clinical operations, or a related field within the...

Radiobotics is a dynamic and innovative company dedicated to solving the global need for radiologists while ensuring every patient receives expert-level care. We are looking for a talented QA/RA specialist to join our Clinical and Regulatory team and contribute to our mission.The ideal candidate will have a strong background in quality assurance and...

Job Description:We are looking for a skilled Medical Writer Consultant to join our team at Pharma IT. In this role, you will work on-site or remotely with our clients in the pharma, biotech, and medical device industries.Key Responsibilities:Write and review nonclinical documents for regulatory submissions.Work closely with cross-functional teams to deliver...

Senior/Principal Medical Writing Consultants Pharma IT is hiring experienced Senior/Principal Medical Writer Consultants to join our Regulatory Affairs & Medical Writing Team In this role, you will work as a consultant to support our clients in the Pharma, Biotech and Medical Device industries. In this position, you will work on-site at the client's...

Senior/Principal Medical Writing ConsultantsPharma IT is hiring experienced Senior/Principal Medical Writer Consultants to join our Regulatory Affairs & Medical Writing TeamIn this role, you will work as a consultant to support our clients in the Pharma, Biotech and Medical Device industries.In this position, you will work on-site at the client's location or...

The Director of Regulatory Affairs ensures that the company's products meet global regulatory requirements, focusing on the USA and Europe, including those set by the FDA, EMA, and other relevant authorities. This role is responsible for developing and executing regulatory compliance strategies, navigating approval processes for pharmaceuticals and medical...

Job DescriptionAt Pharma IT, we are seeking a highly skilled Senior/Principal Medical Writer Consultant to join our Regulatory Affairs & Medical Writing Team.This role will involve working as a consultant to support our clients in the Pharma, Biotech, and Medical Device industries. The ideal candidate will have experience from different biotech and pharma...

The Director of Regulatory Affairs at Black Swans Exist is responsible for ensuring that the company's products meet global regulatory requirements, focusing on the USA and Europe. This role develops and executes regulatory compliance strategies, navigates approval processes for pharmaceuticals and medical devices, and ensures timely updates for existing...

About the RoleWe are looking for a Senior/Principal Medical Writer Consultant with a strong background in medical writing and clinical development to join our team.The ideal candidate will have at least 10 years of experience within drug development in the pharma/biotech industry, with a minimum of 5 years of experience in medical writing.Main...

Job OverviewGenmab A/S is seeking a highly motivated and experienced Regulatory Affairs professional to join our Global Regulatory Affairs team as an Associate Director, EU/ROW Regulatory Lead. The successful candidate will be responsible for representing RA in the Clinical Trial Teams, ensuring regulatory oversight and progress of multiple clinical trial...

Radiometer Danmark / Danaher is a leading provider of diagnostic solutions. Our purpose is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a key member of our team, you will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory support for...

At Genmab, we're committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.We're seeking a Senior Regulatory Affairs Manager to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible...

We are seeking a dedicated and experienced Regulatory Affairs Manager.As part of our team, you will be responsible for Oresund Pharma's products worldwide with the purpose to develop and maintain a global product portfolio following regulatory requirements and commercial demands.As Regulatory Affairs Manager, you will be responsible for your own portfolio...

Oresund Pharma ApS is seeking a dedicated and experienced Regulatory Affairs Manager to join our team.Responsibilities:Lifecycle management of productsEnsuring compliance with regulationsPreparation and review of regulatory submissionsMaintenance of product informationMonitoring and setting timelinesKeeping up-to-date with legislation and...

We are seeking a dedicated and experienced Regulatory Affairs Manager to join our team at Oresund Pharma ApS.Job Description:The successful candidate will be responsible for developing and maintaining a global product portfolio following regulatory requirements and commercial demands. Key responsibilities include lifecycle management, ensuring products...

We are seeking a highly skilled Senior Manager of Regulatory Processes and Tools to join our Global Regulatory Affairs team. In this role, you will be responsible for driving process improvements and implementing systems and tools within Regulatory Affairs to support efficient regulatory support for the organization and growth of the company.This position is...

Senior Manager/Associate Director, External Programs, Global Medical AffairsAre you passionate about changing the lives of people living with rare diseases? Are you enthusiastic about operations? Do you have experience planning and executing Global Medical Affairs external programs or clinical trials within Clinical Operations?If so, now is your chance to...

About This OpportunityWe're looking for an experienced Senior Regulatory Affairs Professional to join our team at Genmab. As a key member of our Global Regulatory Affairs organization, you'll play a critical role in developing and executing the EU/ROW regulatory strategy for assigned projects. Your expertise will be essential in ensuring regulatory...

About GenmabAt Genmab, we're a biotechnology company with a mission to transform the lives of patients through innovative cancer treatment and therapies. We're driven by our core purpose to strive towards improving patient outcomes with next-generation antibody technology platforms and translational research. Our team is passionate about developing...