Experienced Medical Writer

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Søborg

Are you an experienced Medical Writer looking to grow your career? Do you want to bring scientific communication and project management skills to kick-start your medical writing career at a global healthcare company? If yes, we would love to hear from you! Medical Writing at [xxxxx] is expanding. As we grow into new therapy areas and new indications, we are delighted to be offering positions to join our global team. This is a fantastic opportunity to combine your scientific knowledge and writing skills in a crucial role within [xxxxx]. Apply now for a life-changing career!
About the department
You will join us in Clinical Reporting, the medical writing function at [xxxxx]. We are part of [xxxxx] Development and are anchored together in Regulatory and Quality functional areas. 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 continuous learning, being bold, and striving for simplicity. Clinical Reporting covers all clinical drug development projects across therapy areas. Our 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 communicate clinical data in a clear and concise manner.

The position As an experienced Medical Writer, you will work as a strategic partner in a dynamic environment to bring groundbreaking treatments to patients worldwide through the planning and preparation of a broad range of regulatory documents and scientific publications.
Your main responsibility is to drive the preparation of complex clinical documents and act as a project manager. More specifically, you are expected to lead tasks such as:
  • Planning, development, and oversight of clinical and regulatory documents, including study protocols, informed consent forms, clinical study reports (all phases), investigator’s brochures, clinical summaries, paediatric plans, briefing packages, and responses to health agency questions according to business needs
  • Representing Clinical reporting to cross-functional project teams and providing guidance on regulatory document requirements and optimal data presentation
  • Working collaboratively with other job functions across Development (notably Biostatistics, Pharmacovigilance, Medical & Science, Regulatory Affairs, Clinical Operations, 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
  • In addition to your own medical writing tasks, you will work to develop and improve our internal processes and promote the sharing of better practices across areas
  • Furthermore, you will mentor and train other medical writers and be responsible for the document quality of your team as well as the documents you are authoring
  • The positions are office-based in Denmark, with flexibility for part-time homeworking. Many of our colleagues and stakeholders are based internationally. Relocation support may be considered for candidates with more than 5 years’ experience in regulatory medical writing.

    Qualifications
    As a person, you are a clear communicator who adapts easily to a changing environment with tight deadlines. You are strategic, proactive, and have excellent planning and coordination skills with the competency to drive and engage teams. You effectively manage various stakeholders and can reach consensus. You are thorough and structured while being pragmatic and willing to challenge the status quo. Furthermore, you have a positive, can-do attitude and a good sense of humour. We're looking for candidates who bring these qualifications:
  • You hold a master’s degree within natural sciences (MSc., MSc. Pharm., or equivalent), preferably supplemented with a PhD and/or relevant experience in the pharmaceutical industry.
  • You have a track record of driving your own complex tasks from start to finish, navigating many different stakeholders, and being an expert in communicating scientific information.
  • You can demonstrate your ability to improve processes and promote the sharing of better practices. You have an expert understanding of clinical development, regulatory processes and requirements, and clinical documents.

  • Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. 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 Jasper Neergaard Jacobsen (+[xxxxx]). We will review applications on an ongoing basis, so please do not hesitate to apply now. 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 resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

    Deadline
    21 April 2024. 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.


    Information og data

    Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 26.3.2024, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Forretningsudvikler
    • Søborg

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