Medical Writing Specialist

Are you an experienced Medical Writer looking for possibilities to grow your career further and apply your competencies in a global healthcare company? If yes, then we would love to hear from you.[xxxxx] was founded 100 years ago and has developed into being a world leader in delivering therapeutics to patients with serious chronic diseases. In the role as a Medical Writing Speacilist you will represent Clinical Reporting as a strategic partner in a dynamic environment to bring groundbreaking treatments to patients worldwide through planning and preparing a broad range of regulatory documents.The position
This is a permanent position as a Medical Writing Specialist in the Medical Writing Obesity Department in Clinical Reporting. Your main responsibility is to plan and drive the preparation of simultanous complex clinical documents, engange and influence strategic projects decisions and and act as project manager. More specifically, your are expected to lead tasks such as:
• Planning, development and oversight of clinical/regulatory documents, including study protocols, informed consent forms, investigator’s brochures, clincial summaries, pediatric plans, briefing packages and responses to health agency questions according to business needs.
• Representing Clinical Reporting in cross-functional project teams and providing guidance on planning for regulatory documents, its requirements and optimal data presentation.
• Working collaboratively with other job functions across Development (notably Regulatory Affairs, Biostatistics, Medical & Science, Clinical Operations, Safety Surveillance and others), ensuring all source information and data are appropriately reported in terms of accuracy, completeness and scientific interpretation - all in accordance with project timelines and project strategy.
• Developing and improving our internal processes, and promote the sharing of better practices across areas.
• Ensuring that the strategy within own area is built into the project strategy from an early stage.
• Mentoring and training other medical writers and be responsible for the document quality in your team, as well as your own documents.We are globally oriented, and as a Medical Writing Specilist, you will work in close collaboration with colleagues in cross-functional teams in both Denmark and abroad. The position is office-based in Søborg, Denmark.Qualifications
To succeed in this role, we expect you to have:• A Master’s degree within natural sciences (M.Sc., M.Sc. Pharm. or equivalent), supplemented with a PhD (preferably) and at least 3 years of relevant experience in the pharmaceutical industry.
• A track-record of driving your own complex tasks from start to end, navigating many different stakeholders.
• A high level of expertise in communicating scientific information, with the ability to tailor such information to meet diverse objectives.
• You can demonstrate your ability to improve processes and to promote the sharing of better practices.
• You have expert understanding of clinical development, regulatory processes & requirements and clinical documents.On a personal level, you are an excellent communicator who thrives in a high paced business environment, effortlessly adapting to change, and meeting tight deadlines. Your strategic thinking, proactive approach, and exceptional planning and coordination skills enable you to drive and engage teams effectively. You manage various stakeholders with ease and are adept at reaching consensus. You are thorough and structured, while being pragmatic and not afraid of challenging the status quo. You are also a great team player with strong collaborative skills, always fostering a cooperative and supportive work environment. Additionally, you possess a positive can-do attitude and a great sense of humor.About the department
You will join us in the Medical Writing Obesity Department in Clinical Reporting, the medical writing function at [xxxxx] currently employing approximately 200 medical writers worldwide. We are part of [xxxxx] Development and anchored in the Regulatory, Quality and Clinical Reporting area. Development is responsible for managing clinical drug development and submissions to health authorities worldwide, from the early development phases to market authorisation. Our supportive culture drives business transformation, and we value continouos learning, being bold, and striving for simplicity.Clinical Reporting covers all clinical drug development projects across therapy areas. Our main focus is to use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials, and our main task is to ensure communication of clinical data in a clear and concise manner.Working at [xxxxx]
[xxxxx] is driving change to defeat diabetes and other serious chronic conditions. We use our skills, dedication and ambition to help change lives for the better for patients around the world. We strive for excellence, and for always keeping a positive and collaborative atmosphere in our daily work.
We offer a modern work environment with flexible working, free-flow of coffee and tea, fruit, on-site canteens, take-out dinner options, electric car-charging stations, health insurance, social clubs, and much more.
Contact
For further information please contact Line Pedersen (+[xxxxx]or Ana Silva (+[xxxxx]), between 13:00 and 15:00.Application will be reviewed on an ongoing basis, so please do not hesitate to apply.
Deadline
7th of April 2025. We will review applications on an ongoing basis, so we encourage you to apply as soon as possible.You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.