We are expanding the Medical Writer team to support Nykode’s business goal of expanding and delivering on the pipeline as well as supporting the improvements of compliance across the organization. The role will support across all projects, across different development stages and across all development functions including responsibilities for regulatory, clinical and scientific medical writing. The role will collaborate both with internal as well as external stakeholders. The postion is located either at our office in Oslo, Norway or Lyngby, Denmark.
Job title: Medical Writer
Application deadline: 18. June. Applications will be reviewed on a rolling basis
Location: Oslo, Norway / Lyngby, Denmark
The responsibilities of the position include but are not limited to:
- The Medical Writer (MW) is overall accountable for providing professional and strategic medical writing expertise across the portfolio of Nykode’s development projects.
- The MW is responsible for writing or reviewing, preparing, coordinating and managing clinical trial documents (IB, DSUR, Clinical Study Reports and layman summaries), and regulatory documents (e.g., for CTIS/IND submissions and other documents for Health Authority interactions).
- The MW is expected to participate in cross-functional improvement projects focusing on added value and high quality in all aspects of scientific, medical, regulatory and clinical documentation.
- The MW is accountable for high quality writing, preparing and coordination of manuscripts, abstracts, scientific posters and documents for presentation at external congresses and meetings.
- The MW acts as the in-house expert with respect to medical writing activities and key deliverables. The role is a key member of cross-functional clinical trial teams and project development teams.
- The MW will be the in-house expert on clinical trial result data disclosure and will manage / supervise external or internal resources engaged in trial data disclosure. In addition, the Medical Writer will be engaged in all required document redactions prior to releases.
The role will report to Head of Development Operations
Education and Experience
- University degree in life science or equivalent
- Previous experience from pharma/biotech/CRO within drug development / medical writing
- Fluency in written and oral English
- Good knowledge of GCP and other relevant ICH and applicable regulatory guidelines
- A proven ability to plan, drive, manage, structure, and write large, clear, concise, targeted and reader-friendly scientific, regulatory, clinical and medical documents in a collaboration with many stakeholders
- Strong communication skills
- Technology savvy
- Knowledgeable about clinical development requirements
Who are we looking for?
When hiring new employees, we look for people inspired by our technology and our quest to unlock the future of medicine. We embrace new ways of thinking and doing. When growing and building our teams, we look for people inspired by our mission and those seeking to join a collaborative and value-based company culture. An eagerness to learn and continuously develop is a core characteristic of our highly skilled and competent individuals. A career at Nykode Therapeutics is an opportunity to take part in the journey to push the boundaries of human advancement. Our work is meaningful, and we care. We care about the patients, and we care about each other.
The application process
Applications will be reviewed on a rolling basis. We are looking forward to receiving your application! Apply via the link and please note that we do not accept applications by email.
Should you have any further questions regarding the position, do not hesitate to reach out to: Head of Development Operations Gertrud Rasmussen: gkrasmussen@nykode.com or Senior Medical Writer Michael Lundov: mlundov@nykode.com
