TFS is a Global CRO headquartered in Sweden. We genuinely believe that “Global in mind and local at heart” is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.
As a Medical Writer, you will be responsible for the planning and generation of clinical and regulatory documents and related tasks for our major sponsor in medical devices.
Responsibilities:
- Developing documents for regulatory purposes such as IND, Investigator’s Brochure, DSUR, PSUR, Briefing Books for health Authority interactions
- Developing clinical documents such as Clinical Study Reports (CSRs)
- Coordinating the team contributing to the above mentioned documents, schedule and lead initiation and adjudication meetings
- Gathering, evaluating, organizing, managing and collating information in a variety of formats
- Ensuring compliance with regulations set by the regulatory authorities (primarily FDA and EMA as well as European National Agencies)
- Keeping up to date with changes in regulatory legislation and guidelines
- Analysing complex information
- Providing advice about regulations to scientists
- Ensuring that quality standards are met and submissions meet strict deadlines
- Preparing documentation.
Requirements:
- Relevant degree, such as life science, medicine, biology, chemistry, physics, biochemistry, biotechnology, pharmacy, medicinal chemistry
- Previous employment in life sciences in a position as Clinical Medical Writer in a CRO/Pharmaceutical company
- Medical devices experience
- Experience in new EU regulation as well as MEDDEV 2.7.1 Rev 4
- Fluent in English (Written and verbal)
- Knowledge about requirements of document content and formatting
- Good and fast understanding of biological and clinical complex situations
- Certification from a Writer’s association
- Attention to detail and strong organization skills
Benefits
What we offer:
- The opportunity to be part of a friendly, supportive team and work with exciting technologies
- Home based flexibility
- Competitive salary
- Opportunity to work on a complex trial in challenging therapeutic area
