Medical Writer at Studies&Me
Do you want to use your medical writing skills to help change the way clinical trials are conducted – by pushing the boundaries for technological implementation and putting patients first?
Studies&Me is an ambitious startup company, recently spun out of LEO Innovation Lab. As a digital CRO we are pioneering the concept of decentralized clinical trials by leveraging mobile technologies, offering end-to-end clinical trial solutions within hybrid and virtual trials.
We are a rapidly growing company, and our teams are expanding full speed. We therefore need you on board.
As our Medical Writer, you will be responsible for our end-to-end medical writing and communication in a dynamic and cross-functional organization, currently consisting of 50 engaged and ambitious colleagues.
Amongst your responsibilities will be
- You will be our expert and go-to person when it comes to writing and preparing complex scientific and clinical documents for submission to regulatory authorities, such as protocols, investigator brochures, clinical trials reports, and clinical overviews and summaries.
- You will be working with clients and colleagues from all functional areas in our organization, to whom you will ensure high-quality and concise scientific communication.
- Your meticulous writing skills will be applied to the proof of concept studies in our innovative R&D program which will be key to fuelling our ambitious scientific agenda and supporting our ongoing dialogue with regulators and authorities on decentralized clinical trials.
- You will interpret and explain data generated both from internal and external studies.
What the position offers
- You will have the opportunity to shape our medical writing strategy and practices in Studies&Me, and as a communications specialist and advisor, drive the implementation of good medical communication, for instance through establishing mentor programs or other activities in the organization.
- You will have the opportunity to leave your footprint in the scientific community by writing and contributing to high-quality manuscripts for peer-reviewed journals as well as abstracts, posters and oral presentations for scientific congresses.
- In addition, you will grow an international network and foster a strong collaboration with the scientific community, industry and academia to enhance adoption of our offerings within decentralized clinical trials.
The ideal candidate
- You have a university degree in science (M.Sc., M.Sc. Pharm., MD, or equivalent).
- Knowledge of clinical development and ICH GCP, and experience from a similar job within pharma, CRO or biotech industry.
- A proven track record of scientific publications.
- You have a can-do mindset and thrive having many responsibilities and you are comfortable making decisions also when outside of your comfort zone.
- You understand the importance of aligning and communicating clearly across cross-functional teams, projects and departments.
- It is important that you are comfortable handling many tasks simultaneously and that you are able to handle changes in prioritisation of tasks.
- It is an advantage if you have experience with decentralized clinical trials.
Cultural fit is key to our company, and you would definitely fit in, if you have a winning personality and acknowledge that the best results are delivered through team efforts.
What we offer in addition
- A unique opportunity to work in the heart of Copenhagen in an old Bank (Bikuben) with high ceilings and a beautiful yard.
- A dynamic and international organization, which is also reflected in the employee profiles.
- A friendly, social and engaged work environment where all employees play an important role in each other’s successes.
- A great canteen, with the most wonderful chef who cooks us lunch every day. The canteen also offers an always fully stocked snack bar and drinks fridge.
How to apply or ask us questions about the position
In Studies&Me we know that meaningful results require both the right approach and the right people. This is your opportunity to play an important part in pioneering clinical trials for the benefit of patients.
If you have any questions about the position, please contact Head of Dept, Anders Daniel Andersen, firstname.lastname@example.org, (+45 3121 3896)
Apply by sending your resume and preferably also cover letter to email@example.com – with the subject “Medical Writer”
We are looking to fill this role in Copenhagen, Denmark, in Studies&Me as soon as possible.
The role is placed in the Department of Medical Sciences & Safety with a report line to the head of department, Anders Daniel Andersen.
We look forward to receiving your application!