Principal Medical Writer, Medical Documentation
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full-time
Posted on:
Location Type: Office
Location: Copenhagen • 🇩🇰 Denmark
Visit company websiteJob Level
Lead
About the role
- Preparing regulatory documents that serve their intended purpose
- Analyzing, summarizing, and presenting information in high-level strategic documents and dedicated reports, such as clinical CTD modules (M2.7 clinical summaries and M2.5 clinical overviews), briefing documents, Investigator’s Brochures, and paediatric development plans
- Collaborating closely with dedicated colleagues in other functional areas, such as clinical, regulatory affairs, pharmacovigilance, and biometrics
- Bringing technical expertise to help drive the implementation of new ways of working in a quickly changing technical environment
Requirements
- PhD or master’s degree in medical sciences, life sciences, natural sciences or related areas
- >8 years as a Medical Writer within the pharmaceutical industry, preferably bringing experience from global regulatory filings
- Experience in advising and guiding clinical and regulatory teams on document content and processes
- Experience in artificial intelligence/structured authoring or other technical solutions to medical writing
- Excellent analytical and communication skills
- Fluency in spoken and written English and a flair for writing
- Strong interpersonal and communication skills in a global environment.
Benefits
- Flexible working conditions in a positive and engaged working climate
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingregulatory documentsclinical CTD modulesclinical summariesclinical overviewsbriefing documentsInvestigator’s Brochurespaediatric development plansartificial intelligencestructured authoring
Soft skills
analytical skillscommunication skillsinterpersonal skillscollaborationstrategic thinkingguidanceflair for writingadaptabilityteamworkpresentation skills
Certifications
PhDmaster’s degree