Medical Writer to Pharm Assist Sweden AB
Pharm Assist Sweden AB is strengthening our team of Medical Writers. The main task is to author complex regulatory reports for medicinal and medical device products.
The position include:
- Planning and authoring of non-clinical, clinical, pharmaceutical, and medical devices expert reports such as IB, IMPD, Non-Clinical and Clinical Overview and Summary, Clinical Evaluation/Performance Report
- Writing and updating pharmacovigilance/post-market surveillance documents such as RMP, PSUR/PBRER, DSUR
- Performing literature studies, writing ’state of the art’ reports and white papers etc.
- Quality reviews of your colleagues reports
All reports are to be written in accordance with applicable guidelines, for timely submission to our client, health authorities or other required entities.
The position means working independently and in direct contact with our clients. You are surrounded by colleagues with similar tasks to exchange experiences and support with.
Depending on previous experience and competence you may also be offered to work within outer areas such regulatory affairs or pharmacovigilance.
- Doctor’s degree within medicine, pharmacy, or other related science area.
- Minimum 5 years of experience from the pharmaceutical industry, CRO, health authority or similar.
- Experience in medical/regulatory writing, or similar.
- Fluent speaker and writer of science English.
- Experience from the development of medicinal products or medical devices.
- Experience of pharmacovigilance or regulatory affairs.
- Medical Writing certificate (Europe or North America).
- Fluent speaker and writer of Swedish.
- Service minded (keen ear to client’s requests and views)
- Enjoy deep diving into documentation and problems.
- Ability to closely follow guidelines and templates, and at the same time using creativity to find solutions where possible.
- Manage to work within given timelines, and to closely report the time spent.
- The position is located to our offices in central Uppsala (Fyristorg 6), and occasionally to our clients’ offices, usually in the Uppsala/Stockholm area. However, during the corona pandemic we are home-based, with free access to the office when needed.
- You become the member of a group of colleagues with the same role, and a team leader.
- Preferred start date: around 1 May 2021
- Please apply with CV and a personal letter by 1 April 2021 to firstname.lastname@example.org.
- Any questions about the position are directed to team leader Maria Santesson, phone: 0720-45 35 48, e-mail: email@example.com.
Pharm Assist Sweden AB
Pharm Assist Sweden AB is a professional service company offering quality and regulatory solutions for medicinal products and medical devices. Founded in 1996 the company has assisted more than 200 pharmaceutical and medtech companies over the years. Pharm Assist’s highly qualified team of some twenty professional consultants has a strong scientific, business and regulatory experience and puts pride in providing tailor-made professional solutions in regulatory affairs and quality assurance for our clients.
Pharm Assist’s services range from product registrations and maintenance, pharmacovigilance and post-market surveillance, medical and technical writing, GDP, QSR, ISO 13485 and ISO 14971 to MDR/IVDR compliance for medical devices and IVD medical devices, including medical device software.
Our geographic focus is the Nordic countries. However, we work with clients and projects in many international markets as well. through a well-proven and validated network of partners within regulatory affairs, clinical trials/investigations, medical writing, translations and health economics.
Pharm Assist is located 5 minutes’ walk from Uppsala railway station, close to the Swedish Medical Products Agency and the two prominent universities of Uppsala. The Uppsala/Stockholm region has many pharmaceutical and medical technology companies which serve as the client base, as well as a source of employees.
Our goal is to help the pharmaceutical and medical device industry to develop, manufacture and sell safe medicines and medical devices, and to make the world healthier and safer. At Pharm Assist, the team values of respect for clients and co-workers, responsiveness and collaboration are critical and central, while expertise and quality are right at the heart of everything we do.
Pharm Assist consists of approximately 20 employees. We are organised in five service teams representing different and complementary areas of expertise within quality assurance and regulatory affairs: Pharmacovigilance, GDP, Regulatory affairs, Medical Writing, and Medical Devices. Each team has a team leader with responsibility for day-to-day people management, products and expertise as well as generating business. In addition, we have a QA Manager, a Finance & Administration team as well as a CEO. All of us except for Finance & Administration are involved in supporting clients and generating revenues.