Medical Writer
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Hørsholm
ALK is looking for a Medical Writer who shares our passion for communicating clinical data, who enjoys being part of a small and dedicated team, and who wants to play a key role in project teams throughout the complete lifecycle of our products.
About the team
The Medical Writing department is part of Global Clinical Development at ALK. We are a group of 5 experienced and dedicated colleagues, working with a variety of medical writing tasks. As a Medical Writer you will play an essential role in communicating clinical data in accordance with regulatory requirements and in close collaboration with colleagues across functional disciplines such as Clinical Project Management, Biostatistics, Global Regulatory Affairs, Safety Surveillance, Medical and Science, and other global project teams.
We are based at ALK's headquarters in Hørsholm, Denmark.
Key responsibilities of the Medical Writer:
Your responsibilities include:
- Interpretation and communication of data generated from a variety of sources.
- Writing and preparing complex scientific and clinical documents for submission to regulatory authorities (e.g., clinical trial reports, clinical overview and summaries, briefing books, paediatric investigational plans, protocols, investigator's brochures).
- Writing and contributing to high-quality manuscripts for peer-reviewed journals, as well as abstracts, posters and oral presentations for scientific congresses.
- Project and/or trial team participation.
- Stakeholder and project management.
- Contributing to internal quality assurance activities related to medical writing tasks including continuous improvement of internal processes, standards and systems.
The position reports to Head of Medical Writing.
About you
You have a relevant university degree in life sciences (e.g. PhD, MSc., DVM, MD), and at least one year's experience from a pharmaceutical, medical device or biotech company, from academia/research environment or regulatory authorities. Experience with medical writing, clinical development or another regulated area is an advantage.
Also, we expect the following:
Professional competencies:
- Solid experience with interpretation and communication of data. Experience in preparing regulatory documents based on clinical data and/or publications is an advantage.
- Stakeholder and project management skills.
- English fluency, both written and spoken.
- Advanced computer skills; MS Office, Adobe Acrobat and an aptitude for comprehension of new systems.
Personal competencies:
- Passion for written communication
- Assertive and with a positive attitude
- Team-player with excellent interpersonal skills
- Innovative and open-minded
- Ability to build sustainable cross-functional/cultural relations
- Detail- and quality-oriented coupled with a pragmatic approach
- Capable of assuming responsibility and ownership of tasks
- Ability to work independently and prioritise tasks in accordance with deadlines
- Resilience and flexibility in a dynamic environment
- Pro-activity, self-driven and well-organised.
We offer:
- An opportunity to join a dedicated, professional team with an open and friendly atmosphere, where colleagues share knowledge and help each other.
- An influential and well-respected function with a global outlook, with a broad variety of medical writing tasks and responsibilities.
- Talented and experienced colleagues across functional disciplines.
- Competitive compensation package.
- Possibility for personal and professional development.
Additional information:
Rekrutteringskompagniet A/S is responsible for the recruitment process on behalf of ALK-Abello A/S. Further information about the position can be obtained by contacting Partner Berit Tops, on +45 2174 2322. Your application and CV (in English) should be submitted to us as soon as possible and no later than May 28, 2020.
About the company:
ALK helps people living with allergy. By providing solutions that make life with allergy surprisingly simple we make a difference for many people. We build upon a strong heritage as a pioneer in allergy immunotherapy and we will continue to innovate, develop and market new products and solutions for people with allergy. ALK is a global company with production sites in Denmark, France, Spain and the United States. We were founded in Copenhagen in 1923 and today we employ around 2,300 people around the globe. Our headquarter is based in Hørsholm north of Copenhagen. We know that our employees are our most valuable asset and we believe they do their very best every day in the pursuit of new and better allergy treatments and solutions for people with allergy around the world. If you like to have influence and make a difference ALK is the right place so come join us on our exciting journey.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 30.4.2020, men kan have været deaktiveret og genaktiveret igen.
- Øvrige
- Hørsholm
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