Medical Writer responsible for Clinical Disclosure

Do you want to play a key role in development of the clinical disclosure framework at ALK? Would you like to join a collaborative and enthusiastic team of 7 medical writers in a growing company? Apply today!

The position
Clinical Reporting is a department within Global Clinical Development. We are a growing team of 7 dedicated and skilled medical writers responsible for medical writing and clinical disclosure activities across ALK.

As a Medical Writer responsible for Clinical Disclosure, you will become a central player providing clinical disclosure guidance to development projects across the product portfolio. When joining our team, part of your time will be dedicated to cross-functional work with key stakeholders to continue the development of the clinical disclosure landscape and enhance the concept of transparency by design at ALK.

Your tasks will include:

• Writing and preparing complex scientific and clinical documents for submission to regulatory authorities (e.g., protocols, investigator brochures, clinical study reports, clinical overview and summaries, briefing packages, paediatric investigational plans).
• Participating in cross-functional collaboration related to clinical disclosure and acting as a point-of-contact for clinical disclosure matters.
• Performing surveillance of clinical disclosure legislation and driving development and optimisation of processes, standards, and systems within Global Clinical Development.
• Interpreting and communicating data generated from a variety of sources, including internal and external studies and research documentation.
• Writing and contributing to high-quality manuscripts for peer-reviewed journals.

What you bring
To be a success in this role, you have a background in the natural sciences coupled with a curious mindset and a strong drive to improve existing ways of working. If you are attracted to the idea of implementing new initiatives across the clinical development area, you may be the one we are looking for.

We are driven by a high level of cross-functional collaboration and an open-minded approach, with a supportive team culture where everyone contributes to an inspiring and fun working environment. 

We expect you to have:

• A relevant university degree in the natural sciences (PhD., M.Sc., or equivalent).
• At least 3 years of experience within medical/regulatory writing and a solid understanding of the clinical development value chain.
• Experience with clinical disclosure activities (registries, redaction/anonymisation, lay summaries) and a passion for staying up-to-date in a rapidly evolving field.
• An entrepreneurial spirit and strong collaborative skills, including a flair for training colleagues.
• The ability to thrive in a changing environment while maintaining focus on adding value and ensuring delivery on time.
• Excellent writing and communication skills (fluency in written and spoken English).

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy.

You will be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

If you want to learn more about our company, we encourage you to visit us at www.alk.net. 

Apply
Apply by attaching your CV and a short letter of motivation, no later than 9 February 2025. 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Hence, we prefer that you do not add images in your application documents. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

For further information regarding the position please contact Director, Clinical Reporting, Ida Mosbech Smith on +45 29 88 34 89.

We look forward to hearing from you!