Senior Medical Writer - part time
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Smørum
We provide the evidence to show our hearing aids live up to the highest standards. It’s as simple as that. How we do it not so simple, and that’s why we need you!
In collaboration with the other senior medical writers in the clinical affairs team, you ensure, that the clinical evidence for our hearing solutions is established and maintained throughout the entire device life cycle.
Sounds like you? Then read on!
Providing the evidence
The position and the team are quite central because we directly influence the development and improvement of advanced hearing solutions, ensuring they meet the highest clinical standards and regulatory requirements, and in the end, improve the lives of our users.
Specifically, you will be responsible for writing the clinical evaluations and post market clinical follow-up (PMCF) files, including for example systematic literature reviews, and assessing technical documentation. Our device portfolio of hearing solutions ranges from EU MDR class I to class IIa medical devices, wireless electronic devices with both embedded and standalone software and accessories. We keep an eye on the market and are continuously in dialogue with stakeholders throughout the company.
“There is increased focus on our area of expertise, and we are seen as a valuable and essential part of the device life cycle. Boiled down, we provide the clinical evidence that our devices are safe to use and perform the way they are required to, so our users can receive the best help possible to aid their hearing loss.” tells Anja, Manager of the Clinical Affairs team, and continues “And that is why we are looking for an additional colleague to join our team.”
As part of the clinical affairs team, you will also participate in strategic projects aimed at optimizing procedures and standard operating practices (SOPs), enhancing your skills in medical writing and regulatory affairs.
Small team – big reach
In Clinical Affairs we are a team of 5 committed professionals located in Copenhagen. Our team is responsible for ensuring sufficient clinical evidence to demonstrate conformity to regulatory requirements.
“One of the things you will quickly see in our team, is that we really value each other. We value each other’s skills and share our knowledge both between each other and other colleagues, because we believe that the best results come from a team effort.” says Anja and continues “we also genuinely care about each other."
We may not be the biggest team, but we engage with the entire organisation. Some of our key stakeholders are regulatory affairs in QA/RA, usability and technical experts in R&D, and clinical researchers in Centre of Applied Research Audiology, who you will work closely with to gather your information and just in general keep an ear to the ground on what’s going on.
Medical Writer with medtech experience
You are likely to have a degree within audiology, health tech/science, or similar and have solid experience from working with either hearing aids or other medical devices (EU MDR class IIa or higher).
You know your way around research methodology, information management and medical writing and you have a good understanding of regulatory requirements for medical devices. You also know how to prepare clinical evaluations and PMCF files for EU MDR class IIa (active) medical devices.
To ensure the team meets timelines, you must be good at planning, work structured, be proactive when problems arise, and seek input and advice from relevant colleges across the organization.
You are pragmatic, and equally fond of working in the details and keeping the overview.
This part-time (30 hours/week) position is based at the Demant Head Office in Smørum, Denmark. How you want to structure your hours is something we will agree on together.
Don’t hesitate to reach out
To apply for this position please attach your CV and short motivational letter in English no later than 7th August 2024, by using the link “Apply now”.
For more information about the job, please contact Anja Ravn, Manager of Clinical Affairs on [email protected] or +45 26774422.
Please note that we only accept applications sent through our online platform.
We are excited to hear from you!
In collaboration with the other senior medical writers in the clinical affairs team, you ensure, that the clinical evidence for our hearing solutions is established and maintained throughout the entire device life cycle.
Sounds like you? Then read on!
Providing the evidence
The position and the team are quite central because we directly influence the development and improvement of advanced hearing solutions, ensuring they meet the highest clinical standards and regulatory requirements, and in the end, improve the lives of our users.
Specifically, you will be responsible for writing the clinical evaluations and post market clinical follow-up (PMCF) files, including for example systematic literature reviews, and assessing technical documentation. Our device portfolio of hearing solutions ranges from EU MDR class I to class IIa medical devices, wireless electronic devices with both embedded and standalone software and accessories. We keep an eye on the market and are continuously in dialogue with stakeholders throughout the company.
“There is increased focus on our area of expertise, and we are seen as a valuable and essential part of the device life cycle. Boiled down, we provide the clinical evidence that our devices are safe to use and perform the way they are required to, so our users can receive the best help possible to aid their hearing loss.” tells Anja, Manager of the Clinical Affairs team, and continues “And that is why we are looking for an additional colleague to join our team.”
As part of the clinical affairs team, you will also participate in strategic projects aimed at optimizing procedures and standard operating practices (SOPs), enhancing your skills in medical writing and regulatory affairs.
Small team – big reach
In Clinical Affairs we are a team of 5 committed professionals located in Copenhagen. Our team is responsible for ensuring sufficient clinical evidence to demonstrate conformity to regulatory requirements.
“One of the things you will quickly see in our team, is that we really value each other. We value each other’s skills and share our knowledge both between each other and other colleagues, because we believe that the best results come from a team effort.” says Anja and continues “we also genuinely care about each other."
We may not be the biggest team, but we engage with the entire organisation. Some of our key stakeholders are regulatory affairs in QA/RA, usability and technical experts in R&D, and clinical researchers in Centre of Applied Research Audiology, who you will work closely with to gather your information and just in general keep an ear to the ground on what’s going on.
Medical Writer with medtech experience
You are likely to have a degree within audiology, health tech/science, or similar and have solid experience from working with either hearing aids or other medical devices (EU MDR class IIa or higher).
You know your way around research methodology, information management and medical writing and you have a good understanding of regulatory requirements for medical devices. You also know how to prepare clinical evaluations and PMCF files for EU MDR class IIa (active) medical devices.
To ensure the team meets timelines, you must be good at planning, work structured, be proactive when problems arise, and seek input and advice from relevant colleges across the organization.
You are pragmatic, and equally fond of working in the details and keeping the overview.
This part-time (30 hours/week) position is based at the Demant Head Office in Smørum, Denmark. How you want to structure your hours is something we will agree on together.
Don’t hesitate to reach out
To apply for this position please attach your CV and short motivational letter in English no later than 7th August 2024, by using the link “Apply now”.
For more information about the job, please contact Anja Ravn, Manager of Clinical Affairs on [email protected] or +45 26774422.
Please note that we only accept applications sent through our online platform.
We are excited to hear from you!
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Smørum.
Jobbet er oprettet på vores service den 11.7.2024, 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.
- Øvrige
- Smørum
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