Dawn Health is a leading Digital Health product company that empowers Life Science companies to create elegantly designed digital solutions quickly and in compliance with the highest quality and reliability standards. We are looking for a Medical Writer to join our clinical team in Copenhagen.
The Opportunity:
In this role, you'll dive into a dynamic industry that actively collaborates across the Pharmaceutical, Medical Device, and Technology sectors. As a vital member of our team, you will collaborate closely with experts across the entire organization. We are seeking a dedicated, skilled, and independent Medical Writer to join our team. The successful candidate will play a critical role in ensuring clinical input in all project phases and building up our clinical competencies. You'll enjoy a high degree of freedom to influence your daily work and contribute to the overall development of Dawn Health.
About you:
- You are driven by the same purpose as us, and want to contribute to improving the lives of patients around the world.
- You have a positive and curious mindset.
- You understand how to balance quality and pragmatism to ensure the best possible outcome for a given project.
- You are looking for a fun, friendly, and tolerant working environment in a purpose-driven company where your opinion matters.
- Can work independently, and enjoy building up areas.
Qualifications:
To succeed in this role, we expect you to have:
- A relevant degree within natural sciences (MSc, MSc. Pharm, MD, Nursing, Biology or equivalent).
- Working experience with standards and regulations particularly ISO 14155 and Medical Device Regulation (MDR).
- A strong understanding and experience with clinical documentation, including literature reviews, study protocols, state-of-the-art, post market clinical follow-up plan, and contributions to risk management.
- +3 years of experience working with clinical affairs, medical writing, or similar.
- Full professional proficiency in spoken and written English.
It is a bonus if you have:
- Experience working with Software as a Medical Device (SaMD) or digital health products.
Your Responsibilities:
- Author, edit and provide quality control review on regulatory documents with a primary focus on clinical evaluations, including literature reviews, study protocols, state-of-the-art, post market clinical follow-up plans.
- Clinical data interpretation and presentation.
- Advise the regulatory affairs department on clinical topics. Provide input to clinical and scientific discussions with regulators, notified bodies, and customers.
- Provide oversight on risk management and clinical safety across end-to-end processes.
- Provide input to bidding process as requested.
What We Offer:
- A chance to work alongside innovative colleagues who are great at what they do, and are happy to share their knowledge.
- An open, informal, and friendly atmosphere, that we are proud of and nourish.
- A broad range of meaningful projects and products.
- Autonomy, self-leadership, and confidence in you and your abilities.
- Celebration of our wins and social events on a regular basis to meet and get to know all the Dawn employees.
- Approved training budget.
About Us:
Dawn Health is a digital health company specializing in developing Software as Medical Device (SaMD) and other regulated digital healthcare solutions. We deliver both strategic consulting and development of innovative digital therapies targeting patients on a global scale. Working at Dawn Health is more than just a job. We are not just looking for new employees. We are looking for deeply passionate souls, gifted minds, innovators, team players, entrepreneurs and people who believe they can change the world. We love to build things, change the status quo, and drive a new digital health agenda that will impact more than 1 million patients by 2030.
Our passion not only includes the urge to make a difference, and “Code to Save Lives”, we’re also very focused on our people. There is a great social culture at Dawn Health, and throughout the company you will find warm, helpful, and friendly colleagues. When we hire, we do not just look for professional skills and talent, we look for people who will thrive in our environment and who will make a good addition to the team and contribute to the culture.
Our DNA:
We hire people with a broad set of technical skills who are ready to take on some of technology's greatest challenges and make an impact on millions of patients. At Dawn Health, engineers not only revolutionize the healthcare industry, but they also routinely work on innovation projects with the potential to become large-scale applications and entirely new digital health platforms.
