Principal / Specialist Medical Writer, Medical Documentation

Job title:

Principal / Specialist Medical Writer, Medical Documentation

Company

Lundbeck

Job description

Principal / Specialist Medical Writer, Medical DocumentationLundbeck aspires to impact patients, people, and society through leading innovation within neuro-specialty and neuro-rare fields, while delivering sustainable growth via our Focused Innovator strategy. Your dedication to this strategy is crucial, and we are therefore looking for candidates who are curious, adaptable, and accountable.Are you a focused, innovative, passionate, and responsible Medical Writer whose knowledge and expertise in regulatory medical writing will be an asset to our organization? If so, you could be our next colleague.Your new roleYou will be contributing directly to Lundbeck’s future success by preparing regulatory documents that serve their intended purpose.As lead author, you will analyse, summarise, and present the information in high-level strategic documents and in dedicated reports, such as briefing documents, clinical trial reports, Investigator’s Brochures, paediatric development plans, clinical CTD modules etc. You will do this in close collaboration with dedicated colleagues in other functional areas, such as clinical, regulatory affairs, pharmacovigilance, and biometrics, in a creative and collaborative spirit.You will also bring technical expertise to the position and help drive the implementation of new ways of working in the quickly changing technical environment.Your future teamWe are a very experienced team that drives the development of clinical and regulatory documents and uses our writing, story-lining, and collaboration skills to ensure that scientific information and clinical results are presented clearly and concisely in documents that are fit-for-purpose, so that they properly fulfil regulatory requirements and support Lundbeck’s strategy. We are currently 13 colleagues in Medical Documentation. Your role is based in Lundbeck Valby with most of us; 2 of our colleagues are located in Singapore. We are professional, responsible, and passionate towards our deliveries, colleagues, and society. Ethics and transparency are key drivers. We focus on the well-being of the individual and we offer flexible working conditions in a positive and engaged working climate.What you bring to the teamOur preferred candidate has the following personal and professional qualifications:

• PhD or master’s degree in medical sciences, life sciences, natural sciences or related areas,
• >58 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.

Our promise to youLundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at .Apply nowCan you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.If you have questions, please contact Matilde Thye Kveiborg, Sr Director, Medical Documentation, . Applications must be received by 31st July 2025.Learn more about us at , or Instagram (@h_lundbeck).#EveryBrainInTheGameThis job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

Expected salary

Location

København

Job date

Fri, 27 Jun 2025 22:13:50 GMT

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