Medical Writing Expert Consultant

3 days ago


Copenhagen, Copenhagen, Denmark Pharma IT Full time
Clinical Documentation Specialist

We 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 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.

You will participate in answering questions from health authorities worldwide, write and review scientific publications and presentations, collaborate with cross-functional teams, and ensure compliance with regulatory requirements and industry standards throughout the project lifecycle.

The ideal candidate for this position has 10+ years of experience within drug development in the pharmaceutical or biotechnology industry, with at least 5 years of experience in medical writing. They must have a strong understanding of international regulations, ICH guidelines, and document preparation and production (CTDs).

The successful candidate will possess excellent interpersonal skills, problem-solving abilities, and written and verbal communication skills in English. They will be able to present complex information to diverse audiences and work effectively in multidisciplinary teams.

About Us

Pharma IT aims to deliver price-competitive young talent and experienced professional consultants to the pharmaceutical, biotechnology, and medical device industries. Our exclusive focus on these industries and agile, customer-oriented approach ensures we maximize customer value.

We encourage people of all ages, genders, sexual orientations, nationalities, religions, and ethnic backgrounds to apply. If you want to know more about us, feel free to check out our website at pharmait.dk/about.

How to Apply

This position will be filled on a rolling basis. Interested applicants should apply via LinkedIn. If you have any questions about this role, feel free to reach out to the hiring manager for this position.



  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    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...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    Job DescriptionWe 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)...


  • Copenhagen, Copenhagen, Denmark LEO Pharma Full time

    Your 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...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    Medical 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...


  • Copenhagen, Copenhagen, Denmark LEO Pharma Full time

    Select 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...

  • Senior Consultant

    2 days ago


    Copenhagen, Copenhagen, Denmark Pharma IT Full time

    About 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...

  • Medical Expert

    2 days ago


    Copenhagen, Copenhagen, Denmark PharmaRelations ApS Full time

    OverviewCareers in the central nervous system (CNS) field are essential for improving patients' lives. Neuraxpharm, a leading European specialty pharmaceutical company, is seeking a medical expert to join their team.Key Responsibilities:Execute the medical plan and ensure its success in alignment with Neuraxpharm's strategy.Build and maintain strong...


  • Copenhagen, Copenhagen, Denmark LEO Pharma Full time

    Role 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...

  • Medical Advisor

    2 days ago


    Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    In 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...


  • Copenhagen, Copenhagen, Denmark Allergan Full time

    Company OverviewAbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that solve serious health issues. Our mission is to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care.Job DescriptionWe are seeking a highly...


  • Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    Radiobotics 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...


  • Copenhagen, Copenhagen, Denmark Allergan Full time

    At AbbVie, we are committed to delivering innovative medicines and solutions that solve serious health issues. As a Medical Advisor within our Neuroscience team, you will play a key role in representing the affiliate's medical/scientific voice of expertise for assigned products in the field of neuroscience.The ideal candidate will have a strong background in...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    Clinical 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...


  • Copenhagen, Copenhagen, Denmark European Federation Of Organizations For Medical Physics - EFOMP Full time

    **Job Overview**The ideal candidate will possess most of the following qualifications:M.Sc. degree or higher, preferably within biomedical or electrical engineeringExperience working with QA/QC for medical devicesExperience with mixed technology productsDocumented expertise in main standards governing medical device development and production, such as MDR,...


  • Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    Radiometer Danmark / Danaher is proud to be at the forefront of medical technology, dedicated to improving patient lives with diagnostic tools that address the world's biggest health challenges. Our commitment to innovation and excellence drives us to push beyond boundaries and strive for continuous improvement.We are seeking a highly skilled Medical Advisor...


  • Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    Radiobotics 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...


  • Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    We are Radiobotics ApS, a company driven by aspiration, curiosity, and playfulness. Our mission is to solve the global need for radiologists while ensuring every patient receives expert-level care. We strive to learn what happens beyond the surface and engage with each other in a fun and dynamic environment.We are seeking a highly experienced QA/RA...


  • Copenhagen, Copenhagen, Denmark Responsive AS Full time

    We are seeking a Business Solutions Analyst to join our team at Responsive A/S. As a part-time Business Analyst, you will be responsible for driving our mission to help clients succeed in the digital era.This role is ideal for ambitious students looking to gain real-world experience in a fast-paced consultancy environment. You will work closely with a team...

  • SAP Expert Consultant

    9 hours ago


    Copenhagen, Copenhagen, Denmark StaffHost digital Full time

    Senior SAP Expert Consultant Job Description:About UsWe are a multinational organization committed to fostering a dynamic and inclusive work environment that encourages professional growth and innovation.Key Responsibilities:Lead and manage SAP implementation, configuration, and support projects across various modules.Design, implement, and optimize...


  • Copenhagen, Copenhagen, Denmark Allergan Full time

    Absorb knowledge and apply advanced medical skills as a Medical Advisor within AbbVie's Neuroscience team. Develop your career with us and represent the affiliate's medical/scientific voice of expertise for assigned products in the field of neuroscience.Responsibilities:Maintain professional relationships with experts and academic centersDeliver scientific...