Clinical Documentation Consultant

3 days ago


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

We 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 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 HERAX Full time

    Job DescriptionWe are seeking a talented Life Science Business Consultant to join our team. As a consultant, you will be responsible for planning and executing projects that aim to improve our clients' clinical IT landscape.Your key responsibilities will include working on various projects, collaborating with colleagues, and communicating effectively with...


  • Copenhagen, Copenhagen, Denmark Københavns Universitet Full time

    The University uses third-party technologies to register user behaviour on the website (statistics) to keep improving our service. The University also uses third-party technologies to promote degree programmes, courses, conferences and exhibitions on websites and social media to show you the most relevant offers. 162980 Clinical Professor in Neurology with...


  • 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

    Clinical 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...


  • Copenhagen, Copenhagen, Denmark Københavns Universitet (KU) Full time

    Department of Veterinary Clinical Sciences Faculty of Health and Medical Sciences University of Copenhagen The University seeks to appoint a professor in Veterinary Clinical Pathology to the Department of Veterinary Clinical Sciences to commence as soon as possible. Information on the Department can be found at: and . About us The Department of...


  • Copenhagen, Copenhagen, Denmark Københavns Universitet Full time

    The University uses third-party technologies to register user behaviour on the website (statistics) to keep improving our service. The University also uses third-party technologies to promote degree programmes, courses, conferences and exhibitions on websites and social media to show you the most relevant offers. 162248 Professor in Veterinary Clinical...


  • 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 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...

  • Clinic Director

    2 days ago


    Copenhagen, Copenhagen, Denmark SRG Full time

    SRG Copenhagen, Capital Region of Denmark, Denmark Clinic Director Permanent Up to 984,000 DKK (depending on skills, experience and background) Scope of the role: This is a rewarding, patient-centric role in which you will have responsibility for a range of services and teams in the organisation, utilising your background in the fields of...


  • Copenhagen, Copenhagen, Denmark Nordic Search Group Full time

    About the RoleWe are seeking a highly skilled Clinical Support Specialist to join our team in Denmark.As a Clinical Support Specialist, you will be instrumental in developing and supporting our business within the Clinical Market across Scandinavia.You will report to the Clinical Support Manager based in our European Headquarters in Germany.Your key...


  • Copenhagen, Copenhagen, Denmark HERAX Full time

    About the RoleThis is an exciting opportunity to join HERAX as a Life Science Business Consultant. As a key member of our team, you will play a crucial role in helping our clients optimize their clinical IT landscape.Your primary responsibility will be to plan and execute projects from start to finish. You will work closely with our experienced consultants...


  • Copenhagen, Copenhagen, Denmark HERAX Full time

    At HERAX, we help life science clients achieve operational excellence by providing extensive IT and life science knowledge, experience, and project methodology. We are seeking a Senior Clinical IT Expert to join our team and contribute to this mission.Your main task will be to plan and execute projects for our clients, working collaboratively with others to...


  • Copenhagen, Copenhagen, Denmark HERAX Full time

    As a Digital Transformation Consultant at HERAX, you will play a vital role in helping our clients optimize their clinical processes and take their IT landscape to the next level. This exciting opportunity will give you the chance to combine your interest in life sciences with the business aspects of consulting.About the JobThe successful candidate will have...


  • Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

    Clinical Trial Manager, Clinical Operations Requisition ID: 5984 Location: Copenhagen, Danish Capital Region, DK Clinical Trial Manager, Clinical Operations Do you want to join a motivated, focused global development team, work within our strong portfolio, and make a difference to patients living with brain disease? Are you motivated by having the...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About UsGenmab is an international biotechnology company driven by its core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. Our team strives towards transforming cancer treatment and serious diseases, fostering a collaborative environment where employees can thrive.As a Sr. Associate/Manager in our...


  • Copenhagen, Copenhagen, Denmark HERAX Full time

    We are seeking a highly motivated Clinical IT Specialist to join our team at HERAX. As a key member of our team, you will play a vital role in helping our clients optimize their clinical processes and take their IT landscape to the next level. This is an excellent opportunity to combine your interest in life sciences with the business aspects of...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    We are seeking a highly motivated and organized Sr. Associate/Manager, Clinical Trial Disclosure & Transparency, to join our team at Genmab A/S. In this role, you will be responsible for managing and overseeing public disclosure of clinical trial protocols, results, and document redaction.Key Skills and Qualifications:Strong understanding of clinical...


  • Copenhagen, Copenhagen, Denmark Københavns Universitet Full time

    The University of Copenhagen invites applications for a professorship in Veterinary Clinical Pathology. As a key figure in our Department of Veterinary Clinical Sciences, you will play a crucial role in advancing our research and education in veterinary clinical pathology and companion animal internal medicine.Responsibilities will include conducting...


  • Copenhagen, Copenhagen, Denmark IQVIA Argentina Full time

    About the JobIQVIA Argentina seeks a highly skilled Clinical Research Associate (CRA) to join our team. As a CRA, you will be responsible for monitoring and managing clinical sites to ensure the smooth execution of clinical trials.Key ResponsibilitiesPerform site initiation, monitoring, and close-out visits in accordance with Good Clinical Practice...


  • Copenhagen, Copenhagen, Denmark HERAX Full time

    Kickstart your career as a Life Science Business Consultant Looking for the opportunity to combine your interest in life sciences with the business aspects of consulting? Then grab this career-building chance to work with and learn from talented colleagues as you help digitalize the clinical landscape for clients across the globe. "Not only will you get to...