Medical Writing Specialist
3 days ago
We are seeking a Senior/Principal Medical Writing Consultant to join our team. As a key member of our Regulatory Affairs & Medical Writing Team, you will work as a consultant to support our clients in the Pharma, Biotech, and Medical Device industries.
In this role, you will be responsible for writing and reviewing clinical (and nonclinical) documents for regulatory submissions in the EU and US. This includes Module 2.5, 2.7, 2.4, 2.6, integrated summaries of efficacy/safety, clinical trial protocols and reports, Paediatric Investigational plans, Orphan Drug Designation applications, Investigator's Brochure, meeting requests and briefing documents, and other related documents as requested by our clients.
You will participate in answering questions from Health Authorities worldwide and write and review scientific publications and scientific presentations. Collaboration with cross-functional teams, including external stakeholders, is essential to ensure project goals, deliverables, and requirements are met.
Fostering effective communication and collaboration among project team members is crucial, ensuring clarity of roles and responsibilities. You will also ensure compliance with regulatory requirements and industry standards throughout the project lifecycle.
Evaluating project outcomes and providing recommendations for process improvements and best practices is an important aspect of this role.
-
Medical Writing Expert Consultant
3 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeClinical Documentation SpecialistWe are looking for a skilled Clinical Documentation Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6, integrated...
-
Medical Writing and Clinical Disclosure Professional
23 hours ago
Copenhagen, Copenhagen, Denmark LEO Pharma Full timeSelect how often (in days) to receive an alert: Medical Writing and Clinical Disclosure Professional Field of work: Clinical Development Posting Date: 12 Mar 2025 Role Description Are you a skilled professional with a passion for medical writing and clinical disclosure? LEO Pharma is seeking a talented Medical Writing and Clinical Disclosure Professional to...
-
Medical Writing Expert for Clinical Disclosure
17 hours ago
Copenhagen, Copenhagen, Denmark LEO Pharma Full timeYour Role: As a Medical Writing and Clinical Disclosure Professional, you will play a crucial part in planning, managing, and writing clear, concise, and audience-friendly regulatory, scientific, and medical documents. Your main tasks will include:Writing and editing original regulatory, scientific, and medical documents at a professional level.Leading and...
-
Senior/Principal Medical Writing Consultants
3 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeSenior/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...
-
Medical Tenders Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Fresenius Medical Care Full timeFresenius Medical Care is seeking a highly skilled Medical Tenders Specialist to join our team in Denmark. This role plays a pivotal part in ensuring the success of our tender submissions and enhancing our market presence in the healthcare sector.Key Responsibilities:Tender Management: Oversee and analyze the entire tender process with a strong project...
-
Senior Consultant
2 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeAbout the RoleThe ideal candidate for this position holds at least 10 years of experience within drug development in the pharma/biotech industry, with at least 5 years of experience in medical writing. Understanding of international regulations, ICH guidelines, and document preparation and production (CTDs) is required.A strong understanding of clinical...
-
Senior Medical Content Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeMedical Writing Expert ConsultantWe are seeking an experienced Medical Writing Expert Consultant to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will work as a consultant to support our clients in the pharmaceutical, biotechnology, and medical device industries. You will be responsible for writing and reviewing clinical...
-
Medical Advisor
3 days ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeIn our line of work, life isn't a given - it's the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we're located. Creating...
-
Medical Dermatology Expert
5 days ago
Copenhagen, Copenhagen, Denmark LEO Pharma Full timeRole OverviewWe are seeking a highly skilled Medical Dermatology Expert to join our team on a maternity cover basis. As a Global Safety Specialist, you will play a critical role in ensuring compliance and maintaining high standards in adverse event case management.This is a unique opportunity to gain valuable experience, contribute to global safety...
-
Automation Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full timeAt Hays Specialist Recruitment, we are seeking a skilled Automation Specialist to join our team.Job DescriptionWe are looking for an experienced professional to develop and implement automated solutions to streamline data transfer processes. The ideal candidate will have expertise in writing scripts to automate tasks, integrating data transfer tools with...
-
Pharmaceutical Regulatory Affairs Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeRegulatory Affairs Document SpecialistWe are seeking a highly skilled Regulatory Affairs Document Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6,...
-
Copenhagen, Copenhagen, Denmark European Federation Of Organizations For Medical Physics - EFOMP Full timeCompany OverviewWe are a dynamic and globally oriented business that is expanding our organization around the product X1 CBCT unit. Our team is dedicated to bringing CBCT scanning to the next level by enabling true motion correction and high fidelity scanning to clinics across the world.We pride ourselves on providing an opportunity for the industry's best...
-
Refrigeration Equipment Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full timeCompany OverviewHays Specialist Recruitment presents a unique opportunity to join LOWENCO, one of the world's leading manufacturers of ultra-low temperature freezers for the pharmaceutical industry. As a Refrigeration Technician, you will be part of a dynamic and growing company with a flat organization and an informal tone.Job DescriptionAs a Refrigeration...
-
Medical Electrical System Professional
3 days ago
Copenhagen, Copenhagen, Denmark European Federation Of Organizations For Medical Physics - EFOMP Full timeWhy Join UsWe are a unique organization that offers a chance to influence the future of dental imaging. As a member of our team, you will have the opportunity to work on innovative projects, collaborate with skilled colleagues, and contribute to the development of cutting-edge solutions.Our team is dedicated to bringing CBCT scanning to the next level by...
-
Medical device QA/RA specialist
3 days ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeRadiobotics Copenhagen Full-time Salary Competitive Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe...
-
Automated Manufacturing Equipment Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full timeJob DescriptionWe are seeking an Automated Manufacturing Equipment Specialist to join our Technology Innovation department. As a key member of our project team, you will be responsible for specifying next-generation manufacturing equipment for out-sourced manufacturing processes.Your primary focus will be on collaborating with external partners to prepare...
-
Medical Diagnostic Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Randox Laboratories Full timeAbout the RoleWe are seeking a commercially-minded individual to join our sales team at Randox Laboratories. This role involves promoting our clinical products to new customers and managing existing client relationships in the Copenhagen region.Key ResponsibilitiesDeveloping and maintaining effective sales representation to customers such as universities,...
-
Medical Device Quality Assurance Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeRadiobotics Copenhagen is seeking a highly skilled QA/RA specialist to join our Clinical and Regulatory team. As a key member of our team, you will play a central role in maintaining superior product quality and expanding our presence in new markets.This temporary consultancy position requires a seasoned QA/RA expert with a flair for product quality and...
-
Clinical Documentation Consultant
3 days ago
Copenhagen, Copenhagen, Denmark Pharma IT Full timeClinical Documents SpecialistWe are looking for a skilled Clinical Documents Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6, integrated summaries of...
-
Medical device QA/RA Consultant
3 days ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeRadiobotics Copenhagen Freelance Part-time Salary Competitive This is a temporary consultancy position to support while we search for a permanent hire Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations...